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Paltop 44-72565

by Paltop Advanced Dental Solutions Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K130462

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290108693850 UDI-DI Date2 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130462 Date27 Aug 2013DecidedStatusActive

Official records

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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Paltop
Generic name
Dental implant suprastructure kit
Model / Ref / Catalog
44-72565
Primary DI / UDI-DI
07290108693850
510(k) Number
FDA product code
NHA
GMDN term
Dental implant suprastructure kit
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental implant suprastructure kit

Cleared under the same submission (K130462)

Show all (12)

Other devices from Paltop Advanced Dental Solutions Inc.

See all devices from Paltop Advanced Dental Solutions Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number

Other properties (11)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: 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