Identity
- Trade Name
- GC KommonBaseTM FDA UDI
- Generic Name
- Light-cured dental restorative composite resin FDA UDI
- Device Name
- GC KommonBaseTM LV Pink 2 syringe pack FDA UDI
- Model / Reference
- 90-1300-0000 FDA UDI
- Description
- GC KommonBaseTM LV Pink 2 syringe pack FDA UDI
Identifiers
- Catalog Number
- 90-1300-0000 FDA UDI
- Primary DI / UDI-DI
- E53590130000001 FDA UDI
- 510(k) Number
- K143667 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Light-cured dental restorative composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3750 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
Category: Light-cured dental restorative composite resin
GC KommonBaseTM by GC Orthodontics America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Light-cured dental restorative composite resin.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Herculite Ultra Flow — KERR CORPORATION · Class II
- Herculite Ultra — KERR CORPORATION · Class II
- Herculite Ultra — KERR CORPORATION · Class II
- Herculite Ultra — KERR CORPORATION · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- STARTFLOW — DANVILLE MATERIALS, LLC · Class II
- Vivid NuFill Unit Dose A3 — PEARSON DENTAL SUPPLIES, INC. · Class II
Cleared under the same submission
K143667 also covers:
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
- GC Orthodontics America Inc.
Sources (1)
- FDA UDI f8153392-fc10-450b-a898-d0e93756ee73 37 fields · synced May 30, 2026