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Temp Silicon Brush TPS2

by Micerium SpA

Part of a family of 28 devices: see the family page

Ref TPS2

Temp Silicon Brush TPS2 is a Class I device made by Micerium SpA, registered in EUDAMED on 8 Feb 2022 (Basic UDI-DI ++EMICFAM1DVD) and listed in FDA GUDID since 25 Nov 2019 (UDI-DI EMICTPS21), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EMICFAM1DVD Basic UDI-DI EMICTPS21UDI-DIDate8 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberEMICTPS21 UDI-DI Date25 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++EMICFAM1DVD registered 8 Feb 2022 Active
  • FDA GUDID UDI-DI EMICTPS21 listed 25 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID EMICTPS21
  2. Registered EUDAMED ++EMICFAM1DVD

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Temp Silicon Brush
Generic name
Dental material application tool, reusable
Device name
Ena / Enamel Plus
Model / Ref / Catalog
TPS2
Primary DI / UDI-DI
EMICTPS21
Basic UDI-DI
++EMICFAM1DVD
FDA product code
EJB
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Dental material application tool, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Length — 14.7 Centimeter

Related devices

Category: Dental material application tool, reusable

Similar devices in this category

Other devices filed under CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from Micerium SpA

See all devices from Micerium SpA →

Properties

  • Reprocessed single-use device
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)