FDA UDI
In Commercial Distribution
🇺🇸 United States
QuikGlaze
DI: D816200130GB0
·
Model: 200130GB
·
ALL DENTAL PRODX
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QuikGlaze
- Primary DI
- D816200130GB0
- Version / Model
- 200130GB
- Company Name
- ALL DENTAL PRODX
- Labeler DUNS
- 002287223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-06-12
- Public Version Status
- Update
- Public Device Record Key
- e7572890-8862-4853-a809-3c14da434b35
Device Description
A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45294 | Dental restorative material varnish | A liquid substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration (especially when a dental silicate or glass ionomer cement is used as a filling material). The device typically consists of dissolved artificial resins. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D816200130GB0 | HIBCC |
Customer Contacts
- Phone
- 877-647-7639
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 78 Degrees Fahrenheit