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i-Gen IGM1522

by Megagen Implant Co. Ltd

i-Gen IGM1522 is a Class II device made by Megagen Implant Co. Ltd, cleared under FDA 510(k) K131289 on 25 Sep 2013 and listed in FDA GUDID since 25 Jun 2015 (UDI-DI 08806388221752), 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) K131289

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 Number08806388221752 UDI-DI Date25 Jun 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131289 Date25 Sep 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131289 decided 25 Sep 2013 Active
  • FDA GUDID UDI-DI 08806388221752 listed 25 Jun 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131289
  2. Listed FDA GUDID 08806388221752

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
i-Gen
Generic name
Dental bone matrix implant, metallic
Model / Ref / Catalog
IGM1522
Description
i-Gen Type D1
Primary DI / UDI-DI
08806388221752
510(k) Number
FDA product code
JEY
GMDN term
Dental bone matrix implant, metallic
Device class
Class II
Regulation number
872.4760
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental bone matrix implant, metallic

Cleared under the same submission (K131289)

and 7 more cleared under K131289

Similar devices

Other devices filed under FDA product code JEY (Plate, Bone).

Other devices from Megagen Implant Co., Ltd.

See all devices from Megagen Implant Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)