AnyOne Internal Fixture IF7008

by Megagen Implant Co. Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08806388221462 UDI-DI	Date25 Jun 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: AnyOne Internal Fixture
Generic name: Screw endosteal dental implant, two-piece
Model / Ref / Catalog: IF7008
Description: AnyOne Internal Ø7/ L=8.5

Primary DI / UDI-DI: 08806388221462
510(k) Number: K123988
FDA product code: DZE
GMDN term: Screw endosteal dental implant, two-piece

Device class: Class II
Regulation number: 872.3640
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Serial number
Expiration date
Manufacturing date

Other properties (7)

Sterilise before use: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No