Airlight HP3021P
by Beyes Dental Canada Inc 2 variants
Airlight HP3021P (M800P-S/W) is a pneumatic dental handpiece coupler (FDA Class I; FDA product code EFB, Handpiece, Air-Powered, Dental) made by Beyes Dental Canada Inc, cleared under FDA 510(k) K112623 on 16 Dec 2011 and listed in FDA GUDID since 11 May 2023 (UDI-DI 00990010302075), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00990010302075 | Date11 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112623 | Date16 Dec 2011 | StatusActive |
Official records
- AccessGUDID record 00990010302075
- FDA 510(k) database K112623
Across registries
- FDA 510(k) K112623 decided 16 Dec 2011 Active
- FDA GUDID UDI-DI 00990010302075 listed 11 May 2023 Listed
Timeline
- Cleared FDA 510(k) K112623
- Listed FDA GUDID 00990010302075
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Airlight
- Generic name
- Pneumatic dental handpiece coupler
- Model / Ref / Catalog
- HP3021P, M800P-S/W
- Primary DI / UDI-DI
- 00990010302075
- 510(k) Number
- FDA product code
- EFB
- GMDN term
- Pneumatic dental handpiece coupler
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Safe
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