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Integrity® Temporary Crown & Bridge Material With Fluorescence Cartridge System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Integrity® Temporary Crown & Bridge Material With Fluorescence Cartridge System FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- Integrity Temporary Crown and Bridge Material, A3, Cartridge Refill Package FDA UDI
- Model / Reference
- 666360 FDA UDI
- Description
- Integrity Temporary Crown and Bridge Material, A3, Cartridge Refill Package FDA UDI
Identifiers
- Catalog Number
- 666360 FDA UDI
- Primary DI / UDI-DI
- D0026663600 FDA UDI
- 510(k) Number
- K013674 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 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
- Weight — 76 Gram FDA UDI
Category: Temporary dental crown/bridge
Integrity® Temporary Crown & Bridge Material With Fluorescence Cartridge System by Dentsply International — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Temporary dental crown/bridge.
- Visalys Temp — Kettenbach GmbH & Co. KG · Class II
- artBloc Temp — Merz Dental GmbH · Class II
- VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
- VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
- IDODENTINE — UNION DENTAL SA · Class II
- 10TEMP — UNION DENTAL SA · Class II
- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
Cleared under the same submission
K013674 also covers:
- Luxatemp® Automix Plus — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Automix Plus — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Automix Plus — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Automix Plus — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Automix Plus — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Automix Plus — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Automix Plus — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Automix Solar — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Fluorescence — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Fluorescence — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Fluorescence — DMG Chemisch-Pharmazeutische Fabrik GmbH
- Luxatemp® Fluorescence — DMG Chemisch-Pharmazeutische Fabrik GmbH
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 08bcf042-cbd4-49db-ac3d-b23da960ed72 38 fields · synced May 30, 2026