Identity
- Trade Name
- A-dec FDA UDI
- Generic Name
- Pneumatic dental power tool system handpiece tip, reusable FDA UDI
- Device Name
- Air LS Package,181P,Prophy Wiz,OTC FDA UDI
- Model / Reference
- 54.0880.00 FDA UDI
- Description
- Air LS Package,181P,Prophy Wiz,OTC FDA UDI
Identifiers
- Catalog Number
- 54.0880.00 FDA UDI
- Primary DI / UDI-DI
- 10194665004514 FDA UDI
- 510(k) Number
- K073478 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Pneumatic dental power tool system handpiece tip, reusable 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
Moist Heat or Steam Sterilization FDA UDI
Category: Pneumatic dental power tool system handpiece tip, reusable
A-dec by A-Dec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic dental power tool system handpiece tip, reusable.
- Hydrolux by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- Athena Champion — YOUNG DENTAL MANUFACTURING I, LLC · Class I
- A-dec — A-Dec, Inc. · Class I
- A-dec — A-Dec, Inc. · Class I
- A-dec — A-Dec, Inc. · Class I
- A-dec — A-Dec, Inc. · Class I
- A-dec — A-Dec, Inc. · Class I
- A-dec — A-Dec, Inc. · Class I
Cleared under the same submission
K073478 also covers:
- A-dec — A-Dec, Inc.
- EXPERT LUX Case 680465LRN — KaVo Dental GmbH
- EXPERTmatic E15 C — KaVo Dental GmbH
- EXPERTmatic E15 L — KaVo Dental GmbH
- EXPERTmatic E20 C — KaVo Dental GmbH
- EXPERTmatic E25 C — KaVo Dental GmbH
- EXPERTmatic E25 L — KaVo Dental GmbH
- EXPERTmatic E31 C — KaVo Dental GmbH
- EXPERTtorque E675 LMW — KaVo Dental GmbH
- EXPERTtorque E679 L — KaVo Dental GmbH
- EXPERTtorque LUX E680 L — KaVo Dental GmbH
- EXPERTtorque LUX E680 LM — KaVo Dental 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- A-Dec, Inc.
Sources (1)
- FDA UDI c9563ea2-cc70-4806-895a-184fc620067e 35 fields · synced Jun 8, 2026