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Paltop 21-70018

by Paltop Advanced Dental Solutions Inc.

Ref 21-70018

Paltop 21-70018 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-07290108695625), cleared under FDA 510(k) K130462 on 27 Aug 2013 and listed in FDA GUDID since 14 Dec 2020 (UDI-DI 07290108695625), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-07290108695625 Basic UDI-DI 07290108695625UDI-DIDate9 Oct 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-07290108695625 Basic UDI-DI 07290108695625UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108695625 UDI-DI Date14 Dec 2020ListedStatusListed 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-07290108695625 registered 9 Oct 2026 Active· +1 more in the status table
  • FDA 510(k) K130462 decided 27 Aug 2013 Active
  • FDA GUDID UDI-DI 07290108695625 listed 14 Dec 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-0836-2020 FDA Class II initiated 18 Nov 2019

    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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K130462
  2. Recall initiated FDA recalls Z-0836-2020
  3. Listed FDA GUDID 07290108695625
  4. Registered EUDAMED B-07290108695625

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Dynamic Dental Implant Ø3.25mm L10mm EUDAMED
Paltop GUDID
Generic name
Screw endosteal dental implant, two-piece
Device name
Dental Implants
Model / Ref / Catalog
21-70018
Primary DI / UDI-DI
07290108695625
Basic UDI-DI
B-07290108695625, 729010869P2170001W6
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)
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Length — 10 Millimeter
Outer Diameter — 3.25 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 (K130462)

and 8 more cleared under K130462

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Paltop Advanced Dental Solutions Inc.

See all devices from Paltop Advanced Dental Solutions Inc. →

Properties

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