Identity
- Trade Name
- Airlight EUDAMEDFDA UDI
- Generic Name
- Pneumatic dental handpiece coupler FDA UDI
- Device Name
- M800-M/PD EUDAMEDM800-M/PD, Direct-LED, Triple Ports FDA UDI
- Model / Reference
- HP6018 EUDAMEDFDA UDI
- Description
- M800-M/PD, Direct-LED, Triple Ports FDA UDI
Identifiers
- Catalog Number
- M800-M/PD FDA UDI
- Primary DI / UDI-DI
- 00990010302167 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00990010302167 EUDAMED
- 510(k) Number
- K112623 FDA UDI
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Pneumatic dental handpiece coupler FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Airlight by Beyes Dental Canada Inc — Class I — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 (2)
- FDA UDI a7ad4110-f89b-445e-b5e6-b6a07ef94bbf 35 fields · synced Oct 6, 2026
- EUDAMED 6f2e9eee-0db0-4a5c-8128-ef4e585c8aab 61 fields · synced Jul 9, 2026