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Ena Temp and Enamel Plus Temp

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K103474Ref TEMP6Model TEMPRef TPENMS-1Ref CHFF25Ref TPENMSRef TEMPTRef TPENS2Ref TRBGRef TDRK1Ref TPENMC-1Ref COSPEN11Ref TEMPLRef TPENSX

by Micerium S.p.A.

Identity

Trade Name
ENA / ENAMEL PLUS EUDAMED
Ena Brush FDA UDI
Enamel Plus Temp ® FDA UDI
Enamel Plus Stain & Instruments FDA UDI
Generic Name
Dental restoration carver, resin FDA UDI
Dental acrylic resin FDA UDI
Dental material application tool, reusable FDA UDI
Device Name
ENA / ENAMEL PLUS EUDAMED
ENA BRUSH C for colour FDA UDI
ENAMEL PLUS TEMP TEMPL Self Curing 100 ml Liquid FDA UDI
Enamel Plus Stain and Instruments - 5 Spare blue rubber brush tips sterilizable - 190/180 degrees titl metal handle for compiste modelling FDA UDI
Model / Reference
COSPEN11 EUDAMEDFDA UDI
TEMPL EUDAMEDFDA UDI
TPENMS EUDAMEDFDA UDI
TEMP EUDAMED
TEMP6 EUDAMED
TPENMS-1 EUDAMED
CHFF25 EUDAMED
TEMPT EUDAMED
TPENS2 EUDAMED
TRBG EUDAMED
TDRK1 EUDAMED
TPENMC-1 EUDAMED
TPENSX EUDAMED
Description
ENA BRUSH C for colour FDA UDI
ENAMEL PLUS TEMP TEMPL Self Curing 100 ml Liquid FDA UDI
Enamel Plus Stain and Instruments - 5 Spare blue rubber brush tips sterilizable - 190/180 degrees titl metal handle for compiste modelling FDA UDI

Identifiers

Catalog Number
COSPEN11 FDA UDI
TEMPL FDA UDI
TPENMS FDA UDI
Primary DI / UDI-DI
EMICCOSPEN111 EUDAMEDFDA UDI
EMICTEMPL1 EUDAMEDFDA UDI
EMICTPENMS1 EUDAMEDFDA UDI
EMICTEMP61 EUDAMED
EMICTPENMS11 EUDAMED
+EMICCHFF2512 EUDAMED
EMICTEMPT1 EUDAMED
EMICTPENS21 EUDAMED
EMICTRBG1 EUDAMED
EMICTDRK11 EUDAMED
EMICTPENMC11 EUDAMED
EMICTPENSX1 EUDAMED
Basic UDI-DI
++EMICFAM439 EUDAMED
++EMICFAM1DVD EUDAMED
510(k) Number
K103474 FDA 510(k)FDA UDI
FDA Product Code
EBG FDA 510(k)FDA UDI
EJB FDA UDI
EMDN Code
Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
GMDN Term
Dental restoration carver, resin FDA UDI
Dental acrylic resin FDA UDI
Dental material application tool, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3770 FDA 510(k)
Regulation Number
872.3770 FDA 510(k)FDA UDI
872.4565 FDA UDI
Market of Registration
Italy EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMEDEUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDIFDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.8 Millimeter FDA UDI
Total Volume — 100 Milliliter FDA UDI

This device is a dental material classified as a dental restorative material and temporary filling material, designed for use in restorative dentistry. It is a composite-based system intended for temporary restoration of prepared teeth, providing mechanical support and protection while awaiting definitive treatment. The material is formulated to bond to tooth structure and offer durability during the interim period.

The Ena Temp and Enamel Plus Temp is supplied as a two-component system for dental professionals in clinical settings. It is intended for single-use per application and requires mixing before placement. The product is regulated under FDA 510K and MDR authorisations, with a product code of EBG under the Dental advisory committee. Storage conditions and sterility are manufacturer-specified, though exact details are not provided in the regulatory data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Micerium S.p.A.

Sources (16)

  • FDA 510(k) K103474 24 fields · synced Sep 18, 2026
  • FDA UDI fd94f698-3220-457a-889d-9f18a29bd7d0 35 fields · synced May 24, 2026
  • FDA UDI 8bd5cb47-63a4-4f91-83a9-75c484fdea22 37 fields · synced May 30, 2026
  • FDA UDI e9a87403-2de9-485f-8cd2-b752d511aeda 34 fields · synced May 30, 2026
  • EUDAMED e80558e2-6bae-4f7a-a64c-852536919bf9 61 fields · synced Jul 8, 2026
  • EUDAMED fb12d67b-54dd-405b-9c2e-247914fe38b2 61 fields · synced Jul 12, 2026
  • EUDAMED c09371b0-ce49-4745-a36b-c354e3bd1795 61 fields · synced Jul 14, 2026
  • EUDAMED e5f6dc6b-15cb-4839-b009-4d743ff7f8c4 61 fields · synced Jul 17, 2026
  • EUDAMED 88441cef-1c2a-44d1-87a2-b856c0936099 61 fields · synced Jul 18, 2026
  • EUDAMED 9e08d3ae-22ec-4f30-b90e-23fcaba68cce 61 fields · synced Jul 21, 2026
  • EUDAMED 44058f95-463b-4733-92bd-2802a3cbf5bc 61 fields · synced Jul 22, 2026
  • EUDAMED 9985e0a5-a089-4d79-8dd1-a7f8009d4054 61 fields · synced Jul 23, 2026
  • EUDAMED bb56ebea-5336-4bf1-a2ef-77106ce14017 61 fields · synced Jul 30, 2026
  • EUDAMED ea48a307-201b-4ca7-a705-a8e5040c68a1 61 fields · synced Aug 1, 2026
  • EUDAMED 9ec3c841-f189-4ddf-9629-035a8e5a1fb8 61 fields · synced Aug 3, 2026
  • EUDAMED a58f00c4-e5ca-4c49-aa2c-030cd5bf19da 61 fields · synced Aug 4, 2026