Identity
- Trade Name
- Prime&Bond Elect® Universal Dental Adhesive FDA UDI
- Generic Name
- Dentine adhesive FDA UDI
- Device Name
- Prime&Bond Elect® Universal Dental Adhesive Introductory Kit FDA UDI
- Model / Reference
- 634602 FDA UDI
- Description
- Prime&Bond Elect® Universal Dental Adhesive Introductory Kit FDA UDI
Identifiers
- Catalog Number
- 634602 FDA UDI
- Primary DI / UDI-DI
- D0026346021 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dentine adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDITotal Volume — 3 Milliliter FDA UDI
Category: Dentine adhesive
Prime&Bond Elect® Universal Dental Adhesive by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041343 also covers:
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Xeno® IV One Component Light Cured Self-Etching Dental Adhesive — Dentsply International
- Xeno® IV One Component Light Cured Self-Etching Dental Adhesive — Dentsply International
- Xeno® IV One Component Light Cured Self-Etching Dental Adhesive — Dentsply International
K051463 also covers:
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Prime&Bond Elect® Universal Dental Adhesive — Dentsply International
- Xeno® IV Dual Cure Self-Etching Dental Adhesive — Dentsply International
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
- Dentsply International
Sources (1)
- FDA UDI ea3163a8-222c-48bd-945d-d88c468487ed 38 fields · synced May 30, 2026