Identity
- Trade Name
- Glisten™ Provisional Resin Glaze FDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Device Name
- Provisional Resin Glaze FDA UDI
- Model / Reference
- 151207 FDA UDI
- Description
- Provisional Resin Glaze FDA UDI
Identifiers
- Catalog Number
- 151207 FDA UDI
- Primary DI / UDI-DI
- 00359883003814 FDA UDI
- 510(k) Number
- K082115 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental unfilled resin sealant/coating FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Dental unfilled resin sealant/coating
Glisten™ Provisional Resin Glaze by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental unfilled resin sealant/coating.
- UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
- UltraSeal XT Plus — ULTRADENT PRODUCTS, INC. · Class II
- Ribbon — TULSA DENTAL PRODUCTS LLC · Class II
- UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
- Champ — CENTRIX, INC. · Class II
- OptiGuard — KERR CORPORATION · Class II
- OPTIGLAZE™ — Gc America Inc. · Class II
- RE-GEN Pit & Fissure Sealant — Vista Dental · Class II
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
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 92d483bb-9543-4969-892e-c03f4aea02b1 38 fields · synced Jun 9, 2026