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Paltop 40-70113

by Paltop Advanced Dental Solutions Inc.

Ref 40-70113

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290108695236 Basic UDI-DI 07290108695236UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108695236 UDI-DI Date2 Mar 2021ListedStatusListed 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 on shared 510(k) K112795

    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 on shared 510(k) K112795
    • Terminated Z-1062-2019 FDA Class II initiated 22 Feb 2019 on shared 510(k) K112795
    • Terminated Z-1063-2019 FDA Class II initiated 22 Feb 2019 on shared 510(k) K112795
    • Terminated Z-1064-2019 FDA Class II initiated 22 Feb 2019 on shared 510(k) K112795

    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

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

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  • Withdrawn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
Titanium Base Abutment Internal Hex. SP H3mm Engage S EUDAMED
Paltop GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Prosthetic Components
Model / Ref / Catalog
40-70113
Primary DI / UDI-DI
07290108695236
Basic UDI-DI
B-07290108695236
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 market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Dental implant suprastructure, permanent, preformed

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

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • 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
  • Expiration Date: No
  • Manufacturing Date: No