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MEDENTiKA

FDA UDI

Class I (US FDA UDI)

by Medentika GmbH

Identity

Trade Name
MEDENTiKA FDA UDI
Generic Name
Dental prosthesis/implant abutment screw analog, reusable FDA UDI
Device Name
Laboratory screw FDA UDI
Model / Reference
R 60 L-ET FDA UDI
Description
Laboratory screw FDA UDI

Identifiers

Catalog Number
R 60 L-ET FDA UDI
Primary DI / UDI-DI
EMKAR60LET9 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental prosthesis/implant abutment screw analog, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Dental prosthesis/implant abutment screw analog, reusable

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

Similar devices

Also classified as Dental prosthesis/implant abutment screw analog, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medentika GmbH

Sources (1)

  • FDA UDI bfa3acf1-3a37-4687-b652-52a00773854f 36 fields · synced May 30, 2026