Identity
- Trade Name
- AirLight M800 FDA UDI
- Generic Name
- Dental power tool system handpiece, pneumatic FDA UDI
- Device Name
- M800-M/ST, STAR Backend, Triple Spray, Direct-LED FDA UDI
- Model / Reference
- HP3054 FDA UDI
- Description
- M800-M/ST, STAR Backend, Triple Spray, Direct-LED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628504370810 FDA UDI
- 510(k) Number
- K112623 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental power tool system handpiece, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental power tool system handpiece, pneumatic
AirLight M800 by Beyes Dental Canada Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental power tool system handpiece, pneumatic.
- MK-dent Germany® — MK-Dent GmbH · Class I
- AG Neovo — ASSOCIATED INDUSTRIES CHINA, INC. · Class I
- MicroP Dental — Microp Technology (Taiwan), Inc. · Class I
- AG Neovo — ASSOCIATED INDUSTRIES CHINA, INC. · Class I
- SurgiPro — HENRY SCHEIN, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- PROPHY SPORT — HANDPIECE PARTS & REPAIRS, INC. · Class I
- MK-dent Germany® — MK-Dent GmbH · Class I
Cleared under the same submission
K112623 also covers:
- AirLight M800 45 — Beyes Dental Canada Inc
- AirLight M800 45 — Beyes Dental Canada Inc
- AirLight M800 45 — Beyes Dental Canada Inc
- AirLight M800 45 — Beyes Dental Canada Inc
- AirLight M800 45 — Beyes Dental Canada Inc
- AirLight M800P — Beyes Dental Canada Inc
- AirLight M800P — Beyes Dental Canada Inc
- AirLight M800P — Beyes Dental Canada Inc
- AirLight M800P — Beyes Dental Canada Inc
- AirLight M800P — Beyes Dental Canada Inc
- AirLight M800P — Beyes Dental Canada Inc
- AirLight M800X — Beyes Dental Canada Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beyes Dental Canada Inc
Sources (1)
- FDA UDI 13b048ac-52d4-4c08-8786-2d09bbc2e727 34 fields · synced May 30, 2026