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OptraSculpt 759595AN

by Ivoclar Vivadent Aktiengesellschaft

Ref 759595AN

OptraSculpt 759595AN is a device classified as Class IIa in the EU and Class I in the US made by Ivoclar Vivadent Aktiengesellschaft, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 76152082AINST002S5) and listed in FDA GUDID since 13 Mar 2026 (UDI-DI 07615208482423), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76152082AINST002S5 Basic UDI-DI 07615208482423UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07615208482423 UDI-DI Date13 Mar 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76152082AINST002S5 registered 22 May 2026 Active
  • FDA GUDID UDI-DI 07615208482423 listed 13 Mar 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07615208482423
  2. Registered EUDAMED 76152082AINST002S5

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  • Withdrawn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
OptraSculpt Refill Instrument EUDAMED
OptraSculpt GUDID
Generic name
Dental restoration carver, resin
Device name
Optra Sculpt Instrument
Model / Ref / Catalog
759595AN
Primary DI / UDI-DI
07615208482423
Basic UDI-DI
76152082AINST002S5
FDA product code
KXR
EMDN code
L15900699 Dental material processing instruments, reusable - other
GMDN term
Dental restoration carver, resin
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3140
EU registration type
Standard device
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Similar devices in this category

Other devices filed under DENTAL MATERIAL PROCESSING INSTRUMENTS, REUSABLE - OTHER.

Other devices from Ivoclar Vivadent Aktiengesellschaft

See all devices from Ivoclar Vivadent Aktiengesellschaft →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)