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Paltop 44-70046

by Paltop Advanced Dental Solutions Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 closed

Documents

None

No authorization documents

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 Number07290108699753 UDI-DI Date2 Mar 2021ListedStatusListed GUDID: in commercial distribution

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

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Paltop
Generic Name
Dental implant suprastructure kit
Model / Ref / Catalog
44-70046
Primary DI / UDI-DI
07290108699753
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
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Dental implant suprastructure kit

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
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • 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