MEDENTiKA

FDA UDI

Class II (US FDA UDI)

by Medentika GmbH

Identity

Trade Name: MEDENTiKA FDA UDI
Generic Name: Screw endosteal dental implant, one-piece FDA UDI
Device Name: MINICONE Implant FDA UDI
Model / Reference: 5-01-08 FDA UDI
Description: MINICONE Implant FDA UDI

Identifiers

Catalog Number: 5-01-08 FDA UDI
Primary DI / UDI-DI: 04251574849724 FDA UDI
510(k) Number: K200906 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, one-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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Screw endosteal dental implant, one-piece

MEDENTiKA by Medentika GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Infinity External Hex System — ACE SURGICAL SUPPLY CO., INC. · Class II
KJ Mini Implant System — Kj Meditech · Class II
VERSALIS S PLUS — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
Zirlux — HENRY SCHEIN, INC. · Class II
KLOCKNER — SOADCO, S.L. · Class II
Tryon — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
KJ Mini Implant System — Kj Meditech · Class II
Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II

Cleared under the same submission

K200906 also covers:

MEDENTiKA — Medentika GmbH

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: Medentika GmbH

Sources (1)

FDA UDI b282405b-b7dd-4d60-abbe-1b91db88b5e4 37 fields · synced May 31, 2026