Identity
- Trade Name
- Renamel® NANO™ +plus Compule Starter Kit FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel NANO plus unit dose Starter Kit includes 5 Packages of Renamel NANO plus Compule (20 compules 0.25 g ea./package). FDA UDI
- Model / Reference
- 600605 FDA UDI
- Description
- Renamel NANO plus unit dose Starter Kit includes 5 Packages of Renamel NANO plus Compule (20 compules 0.25 g ea./package). FDA UDI
Identifiers
- Catalog Number
- 600605 FDA UDI
- Primary DI / UDI-DI
- D7796006053 FDA UDI
- GMDN Term
- Dental composite resin 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 composite resin
Renamel® NANO™ +plus Compule Starter Kit by Cosmedent, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Manufacturer's product page: Renamel NANO Plus
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cosmedent, Inc.
Sources (1)
- FDA UDI 6123c4da-0397-4937-a8f9-c2f8f129b99b 34 fields · synced May 30, 2026