AnyOne Internal Fixture

FDA UDI

Class II (US FDA UDI)

by Megagen Implant Co. Ltd

Identity

Trade Name: AnyOne Internal Fixture FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: AnyOne Internal Implant System (C6.6) Ø7.0/ L15.0 FDA UDI
Model / Reference: IF7015 FDA UDI
Description: AnyOne Internal Implant System (C6.6) Ø7.0/ L15.0 FDA UDI

Identifiers

Catalog Number: IF7015XAC FDA UDI
Primary DI / UDI-DI: 08809822767922 FDA UDI
510(k) Number: K123988 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Screw endosteal dental implant, two-piece

Learn about the AnyOne Internal Fixture, a surgical implant device designed to provide support and retention for dental prostheses. This two-piece device consists of an anchorage component implanted into bone and a retention component attached to the anchorage component after implantation. Its unique design features a threaded screw and a gingival-protected abutment, making it suitable for various dental applications.

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Also classified as Screw endosteal dental implant, two-piece.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Megagen Implant Co. Ltd

Sources (1)

FDA UDI c4bf7ad5-3431-40dc-81a3-8ba21fd1be4f 35 fields · synced Jul 31, 2026

AnyOne Internal Fixture

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)