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EdgeTemp™ Plus Hydraulic Temporary Restorative Material
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- EdgeTemp™ Plus Hydraulic Temporary Restorative Material FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- EdgeTemp™ Plus is used for fabrication of temporary fillings for use until the permanent prosthetic is ready for installation. It is supplied in a 40g jar in white (tooth-like) color and is individually boxed. EdgeTemp™ Plus is a water-based temporary filling material used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity. FDA UDI
- Model / Reference
- ETEMPPLUS FDA UDI
- Description
- EdgeTemp™ Plus is used for fabrication of temporary fillings for use until the permanent prosthetic is ready for installation. It is supplied in a 40g jar in white (tooth-like) color and is individually boxed. EdgeTemp™ Plus is a water-based temporary filling material used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818365021031 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 40 Gram FDA UDI
Category: Temporary dental crown/bridge
EdgeTemp™ Plus Hydraulic Temporary Restorative Material by Edge Endo Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary dental crown/bridge.
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- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
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
- Edge Endo Llc
Sources (1)
- FDA UDI e6698cf6-3511-45a7-a7ab-35a3ea08bb40 35 fields · synced May 30, 2026