Identity
- Trade Name
- KOMET Diamond Strip, Polishing Strip FDA UDI
- Generic Name
- Dental abrasive strip, reusable FDA UDI
- Model / Reference
- DS37D.000..A4 FDA UDI
Identifiers
- Catalog Number
- DS37D.000. FDA UDI
- Primary DI / UDI-DI
- E226019695A41 FDA UDI
- FDA Product Code
- EHM FDA UDI
- GMDN Term
- Dental abrasive strip, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 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
Yes
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: Dental abrasive strip, reusable
KOMET Diamond Strip, Polishing Strip by Gebr. Brasseler GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive strip, reusable.
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Defend — Young Innovations, Inc. · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- SB-60HR — GNI Co., Ltd · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- SB-15HD — GNI Co., Ltd · Class I
- SB-40HL — GNI Co., Ltd · Class I
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
- Gebr. Brasseler GmbH & Co. KG
Sources (1)
- FDA UDI d806f987-c1c9-4cc7-b325-8fa6142b40d6 33 fields · synced May 30, 2026