Identity
- Trade Name
- SB-15HR FDA UDI
- Generic Name
- Dental abrasive strip, reusable FDA UDI
- Model / Reference
- SB-15HR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800046027366 FDA UDI
- FDA Product Code
- HRT FDA UDI
- GMDN Term
- Dental abrasive strip, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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: Dental abrasive strip, reusable
Sb-15hr by GNI Co., Ltd — 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
- KOMET Diamond Strip, Polishing Strip — Gebr. Brasseler GmbH & Co. KG · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- KOMET Diamond Strip, Polishing Strip — Gebr. Brasseler GmbH & Co. KG · Class I
- The Orthodontic Store — Young Innovations, Inc. · 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 |
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Manufacturer
- Manufacturer
- GNI Co., Ltd
Sources (1)
- FDA UDI f673932e-1c82-4ca7-af23-39835640cb4c 32 fields · synced May 31, 2026