Identity
- Trade Name
- Airlight FDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Device Name
- Direct-LED, Triple Ports,Direct-LED, Triple Ports FDA UDI
- Model / Reference
- HP3022P FDA UDI
- Description
- Direct-LED, Triple Ports,Direct-LED, Triple Ports FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00837699000307 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
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: 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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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 99ccdbb0-decb-4024-97a5-f0415665b765 34 fields · synced Jun 6, 2026