Identity
- Trade Name
- Seal-Rite™ Procedure Kit FDA UDI
- Generic Name
- Dental pit/fissure sealant FDA UDI
- Device Name
- Kit: 4 x 1.2 mL syringes: 2 Seal-Rite, 1 Etch-Rite, FDA UDI
- Model / Reference
- RITE FDA UDI
- Description
- Kit: 4 x 1.2 mL syringes: 2 Seal-Rite, 1 Etch-Rite, FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701RITE2 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
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 pit/fissure sealant
Seal-Rite™ Procedure Kit by Pulpdent Corporation — 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
- Pulpdent Corporation
Sources (1)
- FDA UDI 4ec6fcaf-7ad5-4f3c-a485-fa9f9d91e348 33 fields · synced Jun 9, 2026