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IPS e.max Press 635560

by Ivoclar Vivadent Aktiengesellschaft

Part of a family of 192 devices: see the family page

Ref 635560

IPS e.max Press 635560 is a device classified as Class IIb in the EU and Class II in the US made by Ivoclar Vivadent Aktiengesellschaft, registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI 76152082BABUT003JC) and listed in FDA GUDID since 8 Aug 2024 (UDI-DI 07615208361322), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76152082BABUT003JC Basic UDI-DI 07615208361322UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07615208361322 UDI-DI Date8 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76152082BABUT003JC registered 11 Jun 2026 Active
  • FDA GUDID UDI-DI 07615208361322 listed 8 Aug 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07615208361322
  2. Registered EUDAMED 76152082BABUT003JC

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  • Withdrawn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
IPS e.max Press Impulse Opal 1 5pcs. EUDAMED
IPS e.max Press GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
635560
Primary DI / UDI-DI
07615208361322
Basic UDI-DI
76152082BABUT003JC
Unit of use DI
07615208512243
FDA product code
EIH
EMDN code
P01020101 Dental implants
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.6660
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 implant suprastructure, permanent, preformed

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Ivoclar Vivadent Aktiengesellschaft

See all devices from Ivoclar Vivadent Aktiengesellschaft →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)