Identity
- Trade Name
- Porcelain Repair Kit (Green) FDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- Porcelain Repair Kit (Green) includes 1 (2.5 cc) PorcelETCH™ Green, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray. FDA UDI
- Model / Reference
- 661005 FDA UDI
- Description
- Porcelain Repair Kit (Green) includes 1 (2.5 cc) PorcelETCH™ Green, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray. FDA UDI
Identifiers
- Catalog Number
- 661005 FDA UDI
- Primary DI / UDI-DI
- D7796610053 FDA UDI
- GMDN Term
- Dental repair kit, ceramic FDA UDI
Classification
- 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
Yes
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: Dental repair kit, ceramic
Porcelain Repair Kit (Green) by Cosmedent, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Cosmedent, Inc.
Sources (1)
- FDA UDI e3bf4b76-a807-487b-8adf-d9ab7eebcf0b 34 fields · synced May 29, 2026