Identity
- Trade Name
- COMFORTtronic 4894 FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- This is a medical device. FDA UDI
- Model / Reference
- 1.005.0169 FDA UDI
- Description
- This is a medical device. FDA UDI
Identifiers
- Catalog Number
- 4894 FDA UDI
- Primary DI / UDI-DI
- EKAV100501690 FDA UDI
- 510(k) Number
- K080677 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental delivery system
COMFORTtronic 4894 by KaVo Dental GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Forest — Ls Enterprises, Inc. · Class I
Cleared under the same submission
K080677 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
- KaVo Dental GmbH
Sources (1)
- FDA UDI f6799ccf-09c6-48af-b034-631f0f1e36f6 37 fields · synced Jun 8, 2026