Identity
- Trade Name
- CosmeSeal FDA UDI
- Generic Name
- Dental pit/fissure sealant FDA UDI
- Model / Reference
- 61710W FDA UDI
Identifiers
- Catalog Number
- 61710W FDA UDI
- Primary DI / UDI-DI
- D77961710W0 FDA UDI
- 510(k) Number
- K042823 FDA UDI
- FDA Product Code
- EBC FDA UDI
- GMDN Term
- Dental pit/fissure sealant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3765 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: Dental pit/fissure sealant
CosmeSeal by Cosmedent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental pit/fissure sealant.
- ICE — Sdi , Ltd. · Class II
- ICE — Sdi , Ltd. · Class II
- Opal Seal — ULTRADENT PRODUCTS, INC. · Class II
- PREVENT SEAL — ITENA CLINICAL · Class II
- AURA — Sdi , Ltd. · Class II
- GLACIER — Sdi , Ltd. · Class II
- SciPharm Pit & Fissure Sealer Bonding Agent — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- Seal-Rite™ Low Viscosity — Pulpdent Corporation · Class II
Cleared under the same submission
K042823 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
- Cosmedent, Inc.
Sources (1)
- FDA UDI 39f16a90-37c7-4dc8-a98b-fc767409362b 34 fields · synced Jun 1, 2026