Identity
- Trade Name
- DELTON® FDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Device Name
- DELTON® Regular Kit Light Curing Pit and Fissure Sealant, Clear. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays. FDA UDI
- Model / Reference
- 27965 FDA UDI
- Description
- DELTON® Regular Kit Light Curing Pit and Fissure Sealant, Clear. Contents: 2 sealant bottles of 2.mL, Etchant bottle of 7 mL, Applicator with Tubes, Disposable Mixing Trays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D003279651 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
- 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 unfilled resin sealant/coating
Delton® by Dentsply Professional — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Dentsply Professional
Sources (1)
- FDA UDI 1eafbe54-0268-4dfe-980e-a8410a0ee467 35 fields · synced Jun 8, 2026