Identity
- Trade Name
- Self Cure Activator FDA UDI
- Generic Name
- Dentine adhesive FDA UDI
- Device Name
- Self Cure Activator Refill FDA UDI
- Model / Reference
- 634354 FDA UDI
- Description
- Self Cure Activator Refill FDA UDI
Identifiers
- Catalog Number
- 634354 FDA UDI
- Primary DI / UDI-DI
- D0026343540 FDA UDI
- 510(k) Number
- K964525 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
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
Dimensions & Sizes
- Size
- Total Volume — 4.5 Milliliter FDA UDI
Category: Dentine adhesive
Self Cure Activator by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentine adhesive.
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- Peak Universal Bond — ULTRADENT PRODUCTS, INC. · Class II
- E-ON — BENCO DENTAL SUPPLY CO. · Class II
- PermaFlo DC — ULTRADENT PRODUCTS, INC. · Class II
- SciPharm Cure-On Touch Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
Cleared under the same submission
K964525 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 |
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Manufacturer
- Manufacturer
- Dentsply International
Sources (1)
- FDA UDI 8af264fd-c39b-483c-9223-4af51e11ce92 38 fields · synced May 29, 2026