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Paltop 20-70008

by Paltop Advanced Dental Solutions Inc.

Ref 20-70008

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290108690071 Basic UDI-DI 07290108690071UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108690071 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

5 recalls · FDA

    • Terminated Z-0019-2020 FDA Class II initiated 30 May 2019

    Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.

  • 4 recalls, same reason

    • Terminated Z-1061-2019 FDA Class II initiated 22 Feb 2019
    • Terminated Z-1062-2019 FDA Class II initiated 22 Feb 2019
    • Terminated Z-1063-2019 FDA Class II initiated 22 Feb 2019
    • Terminated Z-1064-2019 FDA Class II initiated 22 Feb 2019

    Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Advanced Dental Implant Ø4.2mm L11.5mm EUDAMED
Paltop GUDID
Generic Name
Screw endosteal dental implant, two-piece
Device Name
Dental Implants
Model / Ref / Catalog
20-70008
Primary DI / UDI-DI
07290108690071
Basic UDI-DI
B-07290108690071
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 market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 11.5 Millimeter
Outer Diameter — 4.2 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Screw endosteal dental implant, two-piece

Cleared under the same submission (K112795)

Show all (12)

Other devices from Paltop Advanced Dental Solutions Inc.

See all devices from Paltop Advanced Dental Solutions Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No