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Z5-Tl-4012

by Z-Systems AG

Ref Z5-TL-4012

Z5-Tl-4012 is a device classified as Class IIb in the EU and Class II in the US made by Z-Systems AG, registered in EUDAMED on 28 Apr 2026 (Basic UDI-DI B-07640166768937), cleared under FDA 510(k) K201712 on 1 Dec 2020 and listed in FDA GUDID since 12 Feb 2024 (UDI-DI 07640166768937), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201712

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07640166768937 Basic UDI-DI 07640166768937UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640166768937 UDI-DI Date12 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201712 Date1 Dec 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07640166768937 registered 28 Apr 2026 Active
  • FDA 510(k) K201712 decided 1 Dec 2020 Active
  • FDA GUDID UDI-DI 07640166768937 listed 12 Feb 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201712
  2. Listed FDA GUDID 07640166768937
  3. Registered EUDAMED B-07640166768937

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  • Withdrawn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
Z5-Tl
Generic name
Screw endosteal dental implant, two-piece
Device name
Z5-Tl-4012
Model / Ref / Catalog
Z5-TL-4012
Primary DI / UDI-DI
07640166768937
Basic UDI-DI
B-07640166768937
510(k) Number
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Screw endosteal dental implant, two-piece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 12 Millimeter
Outer Diameter — 4 Millimeter

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: Screw endosteal dental implant, two-piece

Cleared under the same submission (K201712)

and 1 more cleared under K201712

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Z-Systems AG

See all devices from Z-Systems AG →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)