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miniMark Dental Implant System 09280205

by Ace Surgical Supply Co., Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number00614950003006 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1835-2017 FDA Class II initiated 22 Feb 2017

    Incorrect device was packaged.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
miniMark Dental Implant System
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
09280205
Primary DI / UDI-DI
00614950003006
510(k) Number
FDA Product Code
DZE
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution
Size
Length — 15 Millimeter

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K093518)

Show all (12)

Other devices from Ace Surgical Supply Co., Inc.

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Properties

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

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No