National Medical Products Administration: Medical Device Classification Catalog to Include 3D Printing Orthodontic Aligners for the First Time; Smartee’s IPO on Shenzhen Stock Exchange Accepted…

NMPA Seeks Public Comments on Medical Device Classification Catalog Revision, Proposes First-Time Inclusion of 3D-Printed Orthodontic Appliances

On June 26, the National Medical Products Administration (NMPA) proposed for the first time to include additively manufactured orthodontic appliances in the "Medical Device Classification Catalog" as Class III devices, encompassing 16 items. It also restricted the intended use of dental scaling equipment to "not for daily oral cleaning." Public comments are accepted until July 30. Official interpretation states that this revision aims to align device classification management with technological advancements and clinical needs, achieving precise regulation.

Smartee's Shenzhen IPO Accepted, 2025 Revenue Up Approximately 19.4% YoY to RMB 938 Million

On June 29, 2026, the ChiNext IPO application of Zhejiang Zhengya Dental Co., Ltd. (Smartee) was accepted by the Shenzhen Stock Exchange. The company plans to raise RMB 901 million, with RMB 396 million allocated for the expansion of custom-made clear orthodontic appliance production, RMB 122 million for R&D center upgrades, RMB 283 million for marketing and promotion, and RMB 100 million for working capital. Founded in 2004, Smartee held a 28.26% domestic market share in 2025, ranking second. Founder Yao Junfeng directly holds 20.91% of the shares.

Guangdong Oral Medical Service Price System Officially Implemented from June 30, 2026

On June 30, 2026, Guangdong Province officially implemented a new oral medical service price system, consolidating services into 114 items with a Price Ceiling. The Government-guided Price cannot be increased. The prices are being implemented in phases, with the first batch of items effective from January 30, 2026, and subsequent batches on March 30 and June 30. The Price Ceilings for routine procedures like orthodontics, root canal treatment, and tooth extraction are RMB 2,600/course, RMB 180/root canal, and RMB 125/tooth, respectively. The notice requires local medical security bureaus to determine guiding prices for public institutions based on the Price Ceiling, strictly manage internal pricing, and publicly disclose information. Non-profit institutions are under key supervision.

Chongqing Proposes Standardizing Prices for 195 Oral Medical Services, Fully Impacted Wisdom Tooth Extraction Capped at RMB 263.6/Tooth

On June 30, 2026, the Chongqing Municipal Medical Security Bureau issued a notice seeking public opinions on prices for 741 oral services across the city, proposing to standardize prices for 195 items. The Price Ceiling for fully impacted wisdom tooth extraction is set at RMB 263.6/tooth, with the comment period ending July 8. The regulation also clarifies that the Government-guided Price serves as the Price Ceiling, with no lower limit. This systematic standardization of price items will further complement regulatory mechanisms and enhance the standardization of industry charging practices.

Henan Proposes Standardizing Oral Medical Service Prices, Fully Impacted Wisdom Tooth Extraction Capped at RMB 560/Tooth

On June 12, 2026, the Henan Provincial Medical Security Bureau announced unified pricing for 114 oral services. Routine orthodontic treatment for primary dentition is priced at RMB 2,500/course, impacted wisdom tooth extraction at a maximum of RMB 560/tooth, and a 20% Pediatric Surcharge applies for children under 6. The new regulation emphasizes that consumable costs are included in the item price. Provinces like Guangdong, Ningxia, and Sichuan have recently initiated similar price consolidation efforts, all following the 114-item guideline issued by the National Healthcare Security Administration (NHSA).

European Commission Launches First-Ever Antitrust Investigation in Medical Device Industry Against Align Technology

On June 30, 2026, the European Commission in Brussels initiated its first antitrust investigation into a medical device company, targeting Align Technology. The probe focuses on the company's practice of bundling its iTero intraoral scanner with Invisalign clear aligners and restricting interoperability. The investigation notes that since 2017, Align has refused to approve automatic order file submissions from competitor scanners and does not accept standard files generated by other scanners. Align Technology denies unfair competition, stating the Commission's action is merely procedural information gathering, and pledges full cooperation.

Align Technology Appoints New China Head, Han Junhao Promoted to APAC EVP

Recently, Align Technology completed a leadership transition in its China operations. Former China Vice President and Managing Director Han Junhao was promoted to Executive Vice President and Managing Director for the Asia-Pacific region, while Cai Lanping succeeded him as China Vice President and Managing Director. The company's global revenue for the full year 2025 reached USD 4.035 billion, a 0.9% year-over-year increase. The European Commission initiated its first medical device antitrust investigation on June 30, 2026, focusing on the bundling of iTero intraoral scanners and Invisalign clear aligners.

Henan Proposes Standardizing Surgical Assistance Fees: Intraoperative Microscopic Imaging Assistance at RMB 240/Procedure

On June 12, 2026, the Henan Provincial Medical Security Bureau released a draft proposal standardizing fees for 37 surgical assistance procedures, including intraoperative microscopic imaging assistance at RMB 240/procedure. Other standardized fees include 3D reconstruction at RMB 280/procedure, model printing at RMB 460/piece, guide plate printing at RMB 1,450/piece, micro-power assistance at RMB 170/procedure, Surgical Navigation at RMB 1,000/procedure, and robotic arm assistance ranging from RMB 1,800 to RMB 25,000/procedure depending on the level. Ningxia and Jiangxi provinces have also introduced corresponding fee standards.

NMPA Center for Medical Device Evaluation Seeks Comments on Comparative Clinical Evaluation for Oral Filling and Repair Materials for Implantation Use

On June 29, 2026, the Center for Medical Device Evaluation (CMDE) of the NMPA released a draft guidance principle for the comparative clinical evaluation of Oral Filling and Repair Materials for Implantation Use, with comments accepted until July 25, 2026. The guidance applies to naturally absorbable Dental Barrier Membranes and Xenogeneic bone graft material classified under code 17-08-06. The CMDE had previously issued registration review guidance principles for Dental Barrier Membranes and oral bone grafting materials for implantation use in April 2025.

National Bureau of Statistics: Dental Equipment Manufacturing Industry Profit Grows 26.4% in Jan-May

On June 27, 2026, the National Bureau of Statistics released industrial enterprise profit data for January-May 2026. The profit of the dental equipment and器具 manufacturing industry increased by 26.4% year-over-year, outpacing the overall growth of industrial enterprises above the designated size by 7.6 percentage points and the manufacturing sector by 6.4 percentage points. During the same period, profits for industrial enterprises above the designated size nationwide grew by 18.8%, manufacturing by 20.0%, and high-tech manufacturing by 44.7%. According to sub-sector data, the pharmaceutical manufacturing industry recorded operating revenue of RMB 944.57 billion in Jan-May, a 1.5% year-over-year decrease, and total profit of RMB 129.05 billion, a 1.3% decrease.

TOPCHOICE MEDICAL CORPORATION Plans Share Buyback and Cancellation Worth Up to RMB 100 Million

On June 27, 2026, TOPCHOICE MEDICAL CORPORATION announced a share buyback plan. The company intends to use between RMB 50 million and RMB 100 million to repurchase approximately 830,000 to 1.66 million shares at a price not exceeding RMB 60.12 per share, representing 0.19% to 0.37% of total share capital. The repurchased shares will be cancelled to reduce registered capital. The buyback funds account for approximately 0.8% of the company's assets. The buyback period will end 12 months from the date of approval by the 2025 shareholders' meeting.

Henry Schein Partners with US Dental Talent Platform GoTu

On June 30, 2026, the dental platform GoTu (formerly TempMee) integrated with Dental Recruitment Services, a wholly-owned subsidiary of Henry Schein, Inc., to provide temporary and permanent dental staffing, alleviating clinic personnel shortages. Founded in 2019 and headquartered in Miami, GoTu has a team of over 120 people and has completed over 500,000 placements. Henry Schein reported dental distribution revenue of USD 1.766 billion in Q1 2026, a 9% year-over-year increase. With over 25,000 employees operating in 34 countries, this partnership further expands its dental human resources service layout.

Spanish Dental Chain Shifts from Franchise to Company-Owned Model, Private Equity Platform Exits with Nearly 3x Return

On June 26, 2026, private equity platform Otium sold its majority stake in Spain's Dental Company to Metric Capital Partners Fund V, achieving a nearly 3x return. Dental Company has transitioned from a franchise model to a company-owned model and plans to expand its store network to approximately 200 by 2028. ARCANO acted as the exclusive financial advisor for the transaction.

Dental AI Platform DentScribe Launches AI Patient Profiling Feature to Enhance DSO Treatment Communication and Acceptance Conversion

On July 1, 2026, dental AI platform DentScribe launched Patient Profiles and Treatment Coordinator Intelligence in Sunnyvale, California. Patient Profiles identifies prevention, surgical intent, emergency tendencies, and treatment acceptance patterns based on SOAP (Subjective, Objective, Assessment, Plan) records, generating profiles only when sufficient evidence exists. Treatment Coordinator Intelligence captures conversations between patients and coordinators or financial staff regarding costs, insurance, and financing, generating structured records and quantifying factors leading to treatment delays. Chairman Ratinder Paul Singh Ahuja emphasized that combining SOAP records with communication data bridges the gap between clinical intent and business execution.

MegaGen Launches Absorbable Collagen Membrane Aimed at Improving Predictability of GBR and GTR Procedures

On June 25, 2026, South Korean dental implant manufacturer MegaGen Implant Co., Ltd. launched the soft-type absorbable collagen membrane Meg-CoL, which received approval from the Ministry of Food and Drug Safety (MFDS) of Korea. The membrane's tensile strength reached up to 1.4 times that of comparison samples in internal tests, making it suitable for GBR (Guided Bone Regeneration) and GTR (Guided Tissue Regeneration) procedures. The product was pre-released at SIDEX 2026 in Seoul, with plans to expand clinical use through promotion.

Pearl Releases National Oral Examination Report: AI Detects 8.7 Times More Carious Teeth Than Traditional Methods

On June 29, 2026, dental AI company Pearl released the "Pearl Oral Health Index." AI imaging detection revealed an average of 6.07 decayed teeth per person, 8.7 times the 0.7 teeth detected by traditional NHANES visual-tactile examination. The report, covering 15 million adult patients across the US, indicated that in areas lacking dentists, the rate of damaged teeth being extracted was 20.8%, compared to 14.9% in dentist-dense areas. Additionally, 36% of carious lesions were not observed again during follow-up, potentially involving clinical changes or AI detection consistency issues.

Two US Dental Chains Hit by Consecutive Hacker Attacks, Over 260GB of Data Breached

On April 29, 2026, Park Dental Research was attacked by INTERLOCK ransomware, resulting in the leak of approximately 260 GB of sensitive patient and employee data. The company filed a notification with Massachusetts regulators on June 26, offering affected individuals 24 months of credit monitoring and up to USD 1 million in insurance compensation. Concurrently, on June 28, 1-800-Dentist was allegedly targeted by the Russia-linked group Qilin, which claimed to have stolen data and demanded a ransom. However, the company has not yet confirmed any cybersecurity incident.

Xi'an Dental Clinic Fined Approximately RMB 280,000 for Operating Nearly 10 Months Without a License

On June 22, 2026, the Health Bureau of Weiyang District, Xi'an, imposed a fine of RMB 250,900 on a dental clinic in Xi'an for operating without a practice license, confiscating illegal income of RMB 27,900 and medical devices. The clinic violated Article 23 of the "Regulations on the Administration of Medical Institutions" and was subject to administrative penalties according to the law.

Wuhan University Team's Oral Imaging Model Published in Nature Sub-Journal, Achieves Clinical-Grade Analysis with 100,000-Level Data Support

On June 25, 2026, the team led by Meng Liuyan from the Hospital of Stomatology, Wuhan University, released the DentFound model. Utilizing imaging data from over 101,000 patients covering 98 oral diseases, the model achieves automatic diagnosis and report generation for dental panoramic radiography (OPG), with performance comparable to radiologists. The model is expected to assist in oral diagnosis and treatment in remote areas. The research was supported by multiple grants, including the National Natural Science Foundation of China.