Identity
- Trade Name
- Insure FDA UDI
- Generic Name
- Fatty acid dental cement FDA UDI
- Model / Reference
- 602101 FDA UDI
Identifiers
- Catalog Number
- 602101 FDA UDI
- Primary DI / UDI-DI
- D7796021010 FDA UDI
- 510(k) Number
- K873356 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Fatty acid dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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: Fatty acid dental cement
Insure by Cosmedent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fatty acid dental cement.
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- Rely-a-Bond — LANCER ORTHODONTICS, INC. · Class II
- Burkhart Non-Eugenol Temporary Cement Automix Syringe 5mL — BURKHART DENTAL SUPPLY CO., THE · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
Cleared under the same submission
K873356 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 |
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Manufacturer
- Manufacturer
- Cosmedent, Inc.
Sources (1)
- FDA UDI f802b7fa-91a2-4d6d-b508-2afa29228b41 34 fields · synced Jun 8, 2026