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UD Implant System UDH6525

by Medimecca Co., Ltd.

UD Implant System UDH6525 is a Class II device made by Medimecca Co., Ltd., cleared under FDA 510(k) K131682 on 5 Dec 2013 and listed in FDA GUDID since 7 Nov 2016 (UDI-DI 08806394600688), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K131682

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806394600688 UDI-DI Date7 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131682 Date5 Dec 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131682 decided 5 Dec 2013 Active
  • FDA GUDID UDI-DI 08806394600688 listed 7 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131682
  2. Listed FDA GUDID 08806394600688

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
UD Implant System
Generic name
Dental implant system
Model / reference
UDH6525
Primary DI / UDI-DI
08806394600688
510(k) Number
FDA product code
NHA
GMDN term
Dental implant system
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Medimecca Co., Ltd.

See all devices from Medimecca Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)