FDA UDI
In Commercial Distribution
🇺🇸 United States
GC RELINE™ II
DI: 14548161321365
·
Model: 010258
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GC RELINE™ II
- Primary DI
- 14548161321365
- Version / Model
- 010258
- Catalog Number
- 010258
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-05
- Public Version
- 1
- Public Version Date
- 2022-08-15
- Public Version Status
- New
- Public Device Record Key
- 99f1eb2c-fbfd-4a58-8dbb-ab90694fb49d
Device Description
GC RELINE™ II Intro Kit Soft contains: 1 GC RELINE II Cartridge Soft 61g(48mL), 1 GC RELINE II Primer for Resin 8g(10mL), 1 GC RELINE II Point for Trimming, 1 GC RELINE II Wheel for Finishing, 1 GC RELINE II Remover for Resin 5g(5.5mL), 6 pieces Mixing Tip II L, 3 Disposable brushes, 1 plastic spatula
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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17610 | Denture reliner, soft, professional | A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). 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 | 14548161321365 | GS1 |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153253 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius