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Paltop 56-70036

by Paltop Advanced Dental Solutions Inc.

Ref 56-70036

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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

Overview

The Paltop device is a prefabricated dental implant suprastructure, temporary, single-use device used for oral soft-tissue healing and sculpturing during the period before the fabrication/rehabilitation and installation of final prosthesis/restoration. It typically includes specialized features such as burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in various shapes, sizes, and materials.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290108696677 Basic UDI-DI 07290108696677UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108696677 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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Plastic Snap-On Closed Tray Impression Coping with Abutment WP EUDAMED
Paltop GUDID
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Device Name
Prosthetic Components
Model / Ref / Catalog
56-70036
Primary DI / UDI-DI
07290108696677
Basic UDI-DI
B-07290108696677
510(k) Number
FDA Product Code
NHA
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Greece
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, temporary, preformed, single-use

Cleared under the same submission (K131451)

Show all (12)

Other devices from Paltop Advanced Dental Solutions Inc.

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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