FDA UDI
In Commercial Distribution
🇺🇸 United States
Glaze
DI: D8370170020
·
Model: Liquid - 16 oz
·
Taub Products
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Glaze
- Primary DI
- D8370170020
- Version / Model
- Liquid - 16 oz
- Catalog Number
- 01-7002
- Company Name
- Taub Products
- Labeler DUNS
- 067488114
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-19
- Public Version
- 4
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 1dd449bd-ac1d-4444-8609-dd76e6bf69c5
Device Description
Glaze contains a translucent acrylic and thinner that gives a gloss coating to provisional and permanent acrylic, and composite restorations. Glaze is quick setting and cures and bonds to all dental resins, including ethyl and methyl methacrylates, bis-acryl resins, polycarbonates, vinyl methacrylate copolymers, resin crowns and laminates, denture base, acrylic denture teeth and composite resins.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBD | Coating, Filling Material, Resin | Dental | 872.3310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45236 | Temporary dental crown/bridge resin | A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8370170020 | HIBCC |
Customer Contacts
- Phone
- +1.201.798.5353
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 16 | Fluid Ounce |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from open flame. See SDS.