Skip to content

i-Gen Screw IA1650

by Megagen Implant Co. Ltd

Ref IA1650

i-Gen Screw IA1650 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-08806388220205SS), cleared under FDA 510(k) K150537 on 21 Jul 2015 and listed in FDA GUDID since 27 Jul 2015 (UDI-DI D-08806388220205SS), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150537

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806388220205SS Basic UDI-DI D-08806388220205SSUDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-08806388220205SS UDI-DI Date27 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150537 Date21 Jul 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08806388220205SS registered 21 Sep 2026 Active
  • FDA 510(k) K150537 decided 21 Jul 2015 Active
  • FDA GUDID UDI-DI D-08806388220205SS listed 27 Jul 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150537
  2. Listed FDA GUDID D-08806388220205SS
  3. Registered EUDAMED B-08806388220205SS

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  • Withdrawn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 Screw
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
IA1650
Description
Common M1.6/ C=5
Primary DI / UDI-DI
D-08806388220205SS EUDAMED
08806388220205 GUDID
Basic UDI-DI
B-08806388220205SS
510(k) Number
FDA product code
NHA
EMDN code
P010299 Odontological prostheses - other
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-08806388220205SS
GUDID
08806388220205
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-08806388220205SS; FDA GUDID lists 08806388220205), 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 implant suprastructure, permanent, preformed

Cleared under the same submission (K150537)

and 8 more cleared under K150537

Similar devices in this category

Other devices filed under ODONTOLOGICAL PROSTHESES - OTHER.

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)