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Paltop 40-70024

by Paltop Advanced Dental Solutions Inc.

Ref 40-70024

Paltop 40-70024 is a device classified as Class IIb in the EU and Class II in the US made by Paltop Advanced Dental Solutions Inc., registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI B-07290108690422), cleared under FDA 510(k) K130462 on 27 Aug 2013 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 07290108690422), 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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130462

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-07290108690422 Basic UDI-DI 07290108690422UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108690422 UDI-DI Date28 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130462 Date27 Aug 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290108690422 registered 9 Oct 2026 Active
  • FDA 510(k) K130462 decided 27 Aug 2013 Active
  • FDA GUDID UDI-DI 07290108690422 listed 28 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0836-2020 FDA Class II initiated 18 Nov 2019 on shared 510(k) K130462

    Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K130462
  2. Listed FDA GUDID 07290108690422
  3. Recall initiated FDA recalls Z-0836-2020
  4. Registered EUDAMED B-07290108690422

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  • Withdrawn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
Titanium Straight Abutment Internal Hex. NP H1mm EUDAMED
Paltop GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Prosthetic Components
Model / Ref / Catalog
40-70024
Primary DI / UDI-DI
07290108690422
Basic UDI-DI
B-07290108690422
510(k) Number
FDA product code
NHA
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Height — 1 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: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K130462)

and 8 more cleared under K130462

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Paltop Advanced Dental Solutions Inc.

See all devices from Paltop Advanced Dental Solutions Inc. →

Properties

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