Identity
- Trade Name
- Dental Basics FDA UDI
- Generic Name
- Dental surgical power tool motor, pneumatic FDA UDI
- Device Name
- Prophy Angle Air Motor, Air Motor + 3 Nose Cones FDA UDI
- Model / Reference
- AM10 FDA UDI
- Description
- Prophy Angle Air Motor, Air Motor + 3 Nose Cones FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850061028143 FDA UDI
- 510(k) Number
- K170261 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
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
Yes
FDA UDI
Category: Dental surgical power tool motor, pneumatic
Dental Basics by Dental Basics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental surgical power tool motor, pneumatic.
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- MK-dent — MK-Dent GmbH · Class I
- AM-20 E RM — W & H Dentalwerk Bürmoos GmbH · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- SABLE - Hygienist Package — Sable Industries Inc · Class I
- SABLE - Hygienist Package — Sable Industries Inc · Class I
Cleared under the same submission
K170261 also covers:
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
- Dental Basics Inc.
Sources (1)
- FDA UDI de665911-85e6-453b-9555-bf13fb035336 34 fields · synced Jun 7, 2026