Identity
- Trade Name
- KOMET CeraDrill FDA UDI
- Generic Name
- Ceramic dental bur FDA UDI
- Model / Reference
- K210L19.204.028.A1 FDA UDI
Identifiers
- Catalog Number
- K210L19.204.028 FDA UDI
- Primary DI / UDI-DI
- E226033795A11 FDA UDI
- 510(k) Number
- K071352 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Ceramic dental bur FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ceramic dental bur
KOMET CeraDrill by Gebr. Brasseler GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic dental bur.
- CTT CERAMIC TISSUE TRIMMER — Rønvig Dental Manufacturing A/S · Class I
- KOMET CeraDrill — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Dental Ceramic Burs — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Dental Ceramic Burs — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET CeraDrill — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Dental Ceramic Burs — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
Cleared under the same submission
K071352 also covers:
- KOMET CeraDrill — Gebr. Brasseler GmbH & Co. KG
- KOMET CeraDrill — Gebr. Brasseler GmbH & Co. KG
- KOMET CeraDrill — Gebr. Brasseler GmbH & Co. KG
- KOMET CeraDrill — Gebr. Brasseler GmbH & Co. KG
- KOMET CeraDrill — Gebr. Brasseler GmbH & Co. KG
- KOMET CeraDrill — Gebr. Brasseler GmbH & Co. KG
- KOMET CeraDrill — Gebr. Brasseler GmbH & Co. KG
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
- Gebr. Brasseler GmbH & Co. KG
Sources (1)
- FDA UDI 8c6d21a3-3d43-4590-aa18-24f5b749f8c0 34 fields · synced Jun 6, 2026