Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Handpiece, Air-Powered, Dental

FDA product code EFB · 248 cleared devices

Class 1 Dental
Regulation
21 CFR 872.4200
Review panel
DE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1976-08-11 – 2026-09-23
EFB 2024-11-12

High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)

Applicant Foshan Soco Precision Instrument Co., Ltd.

K number K241074

View details →
↑