Identity
- Trade Name
- DenteShield Sample Opaque with Fluoride FDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Device Name
- DenteShield Sample Opaque with Fluoride FDA UDI
- Model / Reference
- 685DSSAMP FDA UDI
- Description
- DenteShield Sample Opaque with Fluoride FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858290006598 FDA UDI
- FDA Product Code
- EBC FDA UDI
- GMDN Term
- Dental unfilled resin sealant/coating FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3765 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
DenteShield Sample Opaque with Fluoride by Elevate Oral Care, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Elevate Oral Care, LLC
Sources (1)
- FDA UDI e8de7312-6ac3-4b4d-8598-97d9b172c12b 34 fields · synced Jun 9, 2026