Identity
- Trade Name
- Enamel Plus Temp ® FDA UDI
- Generic Name
- Dental acrylic resin FDA UDI
- Device Name
- ENAMEL PLUS TEMP INTRODUCTORY KIT - 1 TEMPL Self Curing 100 ml Liquid - 1 TEMP50BLUE, BLUE 50G POWDER - 1 TEMP50UD2, UD2 50g POWDER - 1 TEMP50UD3, UD3 50g POWDER - 1 TEMP50UD3,5 UD3.5 50g POWDER - 1 TEMP50UD4, UD4 50g POWDER - 1 TEMP50UE2, UE2 50g POWDER FDA UDI
- Model / Reference
- TEMP1N FDA UDI
- Description
- ENAMEL PLUS TEMP INTRODUCTORY KIT - 1 TEMPL Self Curing 100 ml Liquid - 1 TEMP50BLUE, BLUE 50G POWDER - 1 TEMP50UD2, UD2 50g POWDER - 1 TEMP50UD3, UD3 50g POWDER - 1 TEMP50UD3,5 UD3.5 50g POWDER - 1 TEMP50UD4, UD4 50g POWDER - 1 TEMP50UE2, UE2 50g POWDER FDA UDI
Identifiers
- Catalog Number
- TEMP1N FDA UDI
- Primary DI / UDI-DI
- EMICTEMP1N1 FDA UDI
- 510(k) Number
- K103474 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Dental acrylic resin 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
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 400 Gram FDA UDI
Category: Dental acrylic resin
Enamel Plus Temp ® by Micerium Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental acrylic resin.
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Cleared under the same submission
K103474 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micerium Spa
Sources (1)
- FDA UDI db908a51-b11c-440a-a2a1-9e826ce2cec9 37 fields · synced Jun 8, 2026