Identity
- Trade Name
- Insure Refill Kit FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Insure Regular Refill Kit includes 5 (3 g) syringes of Insure Regular, 1 Simulcure Catalyst (dual-cure catalyst paste), 2 Cosmedent brushes (#1 and #3), and 25 White Nozzle dispensing tips in the Tray. FDA UDI
- Model / Reference
- 602025 FDA UDI
- Description
- Insure Regular Refill Kit includes 5 (3 g) syringes of Insure Regular, 1 Simulcure Catalyst (dual-cure catalyst paste), 2 Cosmedent brushes (#1 and #3), and 25 White Nozzle dispensing tips in the Tray. FDA UDI
Identifiers
- Catalog Number
- 602025 FDA UDI
- Primary DI / UDI-DI
- D7796020253 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
Insure Refill 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
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 d9c4220f-6141-4236-bf4d-785497656e67 34 fields · synced Jun 6, 2026