Identity
- Trade Name
- Enamel Plus Temp ® FDA UDI
- Generic Name
- Dental acrylic resin FDA UDI
- Device Name
- ENAMEL PLUS TEMP INTRODUCTORY KIT - 1 TEMP1-CLEAR; TEMP CLEAR 10g - 1 TEMP1-DOD; TEMP DOD 10g - 1 TEMP1-DOL; TEMP DOL 10g - 1 TEMP1-GREY; TEMP GREY 10g - 1 TEMP1-MO; TEMP MO (orange) 10g - 1 TEMP1-MY; TEMP MY (yellow) 10g - 1 TEMP1-PINK; TEMP PINK 10g - 1 TEMP1-UD0; TEMP UD0 10g - 1 TEMP1-UD1; TEMP UD1 10g - 1 TEMP1-UD5; TEMP UD5 10g - 1 TEMP1-UE1; TEMP UE1 10g - 1 TEMP1-UE3; TEMP UE3 10g - 1 TEMP1-WHITE; TEMP WHITE 10g - 1 TEMPL Self Curing 100 ml Liquid - 1 TEMPLC ENAMEL plus TEMP LIQ. FOTOP. 10ml - 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-OF FDA UDI
- Description
- ENAMEL PLUS TEMP INTRODUCTORY KIT - 1 TEMP1-CLEAR; TEMP CLEAR 10g - 1 TEMP1-DOD; TEMP DOD 10g - 1 TEMP1-DOL; TEMP DOL 10g - 1 TEMP1-GREY; TEMP GREY 10g - 1 TEMP1-MO; TEMP MO (orange) 10g - 1 TEMP1-MY; TEMP MY (yellow) 10g - 1 TEMP1-PINK; TEMP PINK 10g - 1 TEMP1-UD0; TEMP UD0 10g - 1 TEMP1-UD1; TEMP UD1 10g - 1 TEMP1-UD5; TEMP UD5 10g - 1 TEMP1-UE1; TEMP UE1 10g - 1 TEMP1-UE3; TEMP UE3 10g - 1 TEMP1-WHITE; TEMP WHITE 10g - 1 TEMPL Self Curing 100 ml Liquid - 1 TEMPLC ENAMEL plus TEMP LIQ. FOTOP. 10ml - 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-OF FDA UDI
- Primary DI / UDI-DI
- EMICTEMP1NOF1 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 — 540 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.
- PYROPLAST POWDER — AMERICAN TOOTH INDUSTRIES · Class II
- Nic Tone, MDC Dental — MDC DENTAL · Class II
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- REPAIR MATERIAL — AMERICAN TOOTH INDUSTRIES · Class II
- QUARZ, MDC Dental — MDC DENTAL · Class II
- ArgenPMMA 98x14-C4 — ARGEN CORPORATION, THE · Class II
- JUSTI- PAKTO POWDER — AMERICAN TOOTH INDUSTRIES · Class II
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 5eb38096-fe85-4e93-b58f-b26f7a0d1ac5 37 fields · synced Jun 8, 2026