Identity
- Trade Name
- Optiglaze™ FDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- Optiglaze™ Brush Holder, 2 pieces per box FDA UDI
- Model / Reference
- 001535 FDA UDI
- Description
- Optiglaze™ Brush Holder, 2 pieces per box FDA UDI
Identifiers
- Catalog Number
- 001535 FDA UDI
- Primary DI / UDI-DI
- 14548161391948 FDA UDI
- FDA Product Code
- EBD FDA UDI
- GMDN Term
- Dental material application tool, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material application tool, single-use
Optiglaze™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental material application tool, single-use.
- Ultrabrush — YOUNG MICROBRUSH LLC · Class I
- MAXMICRO — PLASDENT CORP. · Class I
- Accessory — BISCO INC. · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- Sponge Pellets (Small) - Container. — Vista Dental · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- HU-FRIEDY — HU-FRIEDY MFG CO., LLC · Class I
- Benda Brush — CENTRIX, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gc America Inc.
Sources (1)
- FDA UDI d3786443-5122-4865-b8db-24343b9ce96e 35 fields · synced May 30, 2026