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Certain® PSKT35

by ZimVie US Corp LLC

Part of a family of 32 devices: see the family page

Ref PSKT35

Certain® PSKT35 is a device classified as Class IIa in the EU and Class I in the US made by ZimVie US Corp LLC, registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI 844868ALJE) and listed in FDA GUDID since 24 Mar 2016 (UDI-DI 00844868014638), 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 Number844868ALJE Basic UDI-DI 00844868014638UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868014638 UDI-DI Date24 Mar 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868ALJE registered 10 Jun 2026 Active
  • FDA GUDID UDI-DI 00844868014638 listed 24 Mar 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00844868014638
  2. Registered EUDAMED 844868ALJE

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  • Withdrawn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
Certain®
Generic name
Dental implant/prosthesis surgical procedure kit
Device name
Populated non-sterile Kits
Model / reference
PSKT35
Primary DI / UDI-DI
00844868014638
Basic UDI-DI
844868ALJE
FDA product code
NDP
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental implant/prosthesis surgical procedure kit
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00844868014638: EUDAMED states Yes, FDA GUDID states No.

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.

Related devices

Category: Dental implant/prosthesis surgical procedure kit

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)