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PROVITEMP Automix syringe

by Itena Clinical

Ref PTEMP1-10

PROVITEMP Automix syringe (PTEMP1-10) is a device classified as Class IIa in the EU and Class II in the US made by Itena Clinical, registered in EUDAMED on 17 Jun 2026 (Basic UDI-DI B-03760260221030), cleared under FDA 510(k) K122551 on 14 Jun 2013 and listed in FDA GUDID since 15 Oct 2016 (UDI-DI 03760260221030), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122551

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760260221030 Basic UDI-DI 03760260221030UDI-DIDate17 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760260221030 UDI-DI Date15 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK122551 Date14 Jun 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760260221030 registered 17 Jun 2026 Active
  • FDA 510(k) K122551 decided 14 Jun 2013 Active
  • FDA GUDID UDI-DI 03760260221030 listed 15 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122551
  2. Listed FDA GUDID 03760260221030
  3. Registered EUDAMED B-03760260221030

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Provitemp
Generic name
Dental composite resin
Model / Ref / Catalog
PTEMP1-10, Automix syringe
Primary DI / UDI-DI
03760260221030
Basic UDI-DI
B-03760260221030
510(k) Number
FDA product code
EMA
EMDN code
Q0101010203 Temporary dental cements
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3275
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PTEMP1-10
GUDID
Automix syringe
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental composite resin

Cleared under the same submission (K122551)

Similar devices in this category

Other devices filed under TEMPORARY DENTAL CEMENTS.

Other devices from Itena Clinical

See all devices from Itena Clinical →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)