Identity
- Trade Name
- A-dec FDA UDI
- Generic Name
- Tooth dryer FDA UDI
- Device Name
- Toothdryer ASSY-CE FDA UDI
- Model / Reference
- 11.0232.00 FDA UDI
- Description
- Toothdryer ASSY-CE FDA UDI
Identifiers
- Catalog Number
- 11.0232.00 FDA UDI
- Primary DI / UDI-DI
- 10194665001414 FDA UDI
- 510(k) Number
- K000968 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Tooth dryer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tooth dryer
A-dec by A-Dec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tooth dryer.
- DEPUY STYLE CAN GLEN REMR LG — Biomet Orthopedics, Inc. · Class II
- A-dec — A-Dec, Inc. · Class I
- A-dec — A-Dec, Inc. · Class I
Cleared under the same submission
K000968 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 |
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Manufacturer
- Manufacturer
- A-Dec, Inc.
Sources (1)
- FDA UDI 43bed41e-f707-4752-a4c5-af3165b6a9dc 35 fields · synced Jun 6, 2026