FDA UDI
Not in Commercial Distribution
🇺🇸 United States
UniFil®
DI: D6584210011
·
Model: 421001
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UniFil®
- Primary DI
- D6584210011
- Version / Model
- 421001
- Catalog Number
- 421001
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 4
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 0288ded4-be1c-4721-8b24-7faa68d7d559
- Distribution End Date
- 2021-08-27
Device Description
UniFil® UniFil Bond Starter Kit (1 x 6mL bottle of UniFil Bond Self-Etching Primer, 1 x 6mL bottle of UniFil Bonding agent & accessories)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KLE | AGENT, TOOTH BONDING, RESIN | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34782 | Dentine bonding agent/set | A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. 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 | D6584210011 | HIBCC |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 46.4 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius