Identity
- Trade Name
- MK-dent FDA UDI
- Generic Name
- Dental surgical power tool motor, pneumatic FDA UDI
- Device Name
- Air Motor FDA UDI
- Model / Reference
- ACCESSORIES FDA UDI
- Description
- Air Motor FDA UDI
Identifiers
- Catalog Number
- AM0002 FDA UDI
- Primary DI / UDI-DI
- E490AM00021 FDA UDI
- 510(k) Number
- K051872 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental surgical power tool motor, 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
Yes
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
Yes
FDA UDI
Category: Dental surgical power tool motor, pneumatic
MK-dent by MK-Dent GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K051872 also covers:
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
- MK-dent — MK-Dent GmbH
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
- MK-Dent GmbH
Sources (1)
- FDA UDI 84be1aa7-c328-443e-96e9-1a64c9e37015 35 fields · synced May 30, 2026