202602 | Dental Implant Navigation Systems Approved for Two Consecutive Months, Digital Processing Material Systems Advance on Multiple Paths

Preface

Medical device registration data serves as a crucial reference for observing the progress of domestic production and shifts in clinical demand structures. In February 2026, a total of 20 dental medical device registrations were completed nationwide, unchanged from February 2025, representing a 0% year-on-year change and a 33.3% month-on-month increase. The registration volume rebounded from the low point in January to the recent normal operating range but remained below the average of the past 14 months (25.3 items/month).

This month, 16 products were registered domestically, accounting for 80.0%; 4 products were registered as imports, accounting for 20.0%. Analyzing the categories of imported registered products, among the 4 imported items this month, abutments and accessories accounted for 2, with one each for tooth bleaching agents and gingival retraction cords. No dental implant systems or digital equipment categories were registered. The registrants were from Israel (MIS), Germany (Alpha Dent), Japan, and South Korea, showing a relatively more dispersed origin compared to the same period last year (concentrated in South Korea). The product categories also shifted from surgical instruments towards precision prosthetic accessories and consumable materials.

From a product structure perspective, abutments and accessories topped this month's registration list with 7 items, covering three tiers: universal, custom-made, and machinable abutment blanks, with participation from both domestic and foreign companies. There were 4 dental implant system registrations, with registrants distributed across Weihai, Guangdong, Xiamen, and Changzhou, marking a relatively high number of domestic implant approvals for a single month recently. Two additive manufacturing materials completed registration, corresponding to metal powder bed fusion and photopolymerization process routes, respectively. Among them, dental selective laser melting cobalt-chromium alloy powder was one of the less common product types on this month's registration list. Additionally, Shanghai Yangshan Medical Technology Co., Ltd. (Shenzhen) completed the Class III registration for an oral implant surgical navigation and positioning system. Following a similar product from Fangtian Yichuang approved in January, this represents the consecutive launch of active devices integrating software and hardware in this category.

The following:

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