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i-Gen IG2W0918

by Megagen Implant Co. Ltd

Ref IG2W0918

i-Gen IG2W0918 is a device classified as Class IIb in the EU and Class II in the US made by Megagen Implant Co. Ltd, registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI B-08806388221691U8), cleared under FDA 510(k) K131289 on 25 Sep 2013 and listed in FDA GUDID since 25 Jun 2015 (UDI-DI D-08806388221691U8), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131289

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806388221691U8 Basic UDI-DI D-08806388221691U8UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-08806388221691U8 UDI-DI Date25 Jun 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131289 Date25 Sep 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08806388221691U8 registered 21 Sep 2026 Active
  • FDA 510(k) K131289 decided 25 Sep 2013 Active
  • FDA GUDID UDI-DI D-08806388221691U8 listed 25 Jun 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131289
  2. Listed FDA GUDID D-08806388221691U8
  3. Registered EUDAMED B-08806388221691U8

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
i-Gen
Generic name
Dental bone matrix implant, metallic
Model / Ref / Catalog
IG2W0918
Description
i-Gen Type B1
Primary DI / UDI-DI
D-08806388221691U8 EUDAMED
08806388221691 GUDID
Basic UDI-DI
B-08806388221691U8
510(k) Number
FDA product code
JEY
EMDN code
Q010301 Periodontal membranes
GMDN term
Dental bone matrix implant, metallic
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.4760
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-08806388221691U8
GUDID
08806388221691
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-08806388221691U8; FDA GUDID lists 08806388221691), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental bone matrix implant, metallic

Cleared under the same submission (K131289)

and 7 more cleared under K131289

Similar devices in this category

Other devices filed under PERIODONTAL MEMBRANES.

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 (15, all answered No)