Identity
- Trade Name
- Optiglaze™ FDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- Optiglaze™ Brush Flat #1, 10 pieces per box FDA UDI
- Model / Reference
- 001534 FDA UDI
- Description
- Optiglaze™ Brush Flat #1, 10 pieces per box FDA UDI
Identifiers
- Catalog Number
- 001534 FDA UDI
- Primary DI / UDI-DI
- D0470015341 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
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Also classified as Dental material application tool, single-use.
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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 |
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Manufacturer
- Manufacturer
- Gc America Inc.
Sources (1)
- FDA UDI 2101b4c6-cb16-4fa1-82e1-ba21caa37c95 35 fields · synced Jun 8, 2026