Identity
- Trade Name
- Airlight FDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Device Name
- M800-M/PD/NS, SMART, Single Stream, Non-Spray, Safeguard Air Technology FDA UDI
- Model / Reference
- HP3057 FDA UDI
- Description
- M800-M/PD/NS, SMART, Single Stream, Non-Spray, Safeguard Air Technology FDA UDI
Identifiers
- Catalog Number
- M800-M/PD/NS FDA UDI
- Primary DI / UDI-DI
- 00990010302129 FDA UDI
- 510(k) Number
- K112623 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Pneumatic dental handpiece coupler 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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Pneumatic dental handpiece coupler
Airlight by Beyes Dental Canada Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pneumatic dental handpiece coupler.
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- MK-dent — MK-Dent GmbH · Class I
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- MK-dent Germany® — MK-Dent GmbH · Class I
- COUPLING MULTIFLEX 4H L — BIEN-AIR PORTUGAL, UNIPESSOAL, LDA · Class I
- StarDental Instrument Solutions — DENTALEZ, INC. · Class I
- SABLE - Kavo Multiflex — Sable Industries Inc · Class I
- Johnson-Promident — Young Innovations, Inc. · Class I
Cleared under the same submission
K112623 also covers:
- AirLight M800 — 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 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
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 |
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Manufacturer
- Manufacturer
- Beyes Dental Canada Inc
Sources (1)
- FDA UDI c0ec0b59-3c31-4793-b7c2-1e7dd224bf75 35 fields · synced May 31, 2026