Kontact

FDA UDI

Class I (US FDA UDI)

by Biotech Dental

Identity

Trade Name: KONTACT FDA UDI
Generic Name: Dental prosthesis/implant abutment screw FDA UDI
Device Name: Castable sleeve for narrow conical abutment +KECEEAVGCNV screw FDA UDI
Model / Reference: KECEEAGCNV FDA UDI
Description: Castable sleeve for narrow conical abutment +KECEEAVGCNV screw FDA UDI

Identifiers

Catalog Number: KECEEAGCNV FDA UDI
Primary DI / UDI-DI: 03701045270799 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental prosthesis/implant abutment screw 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dental prosthesis/implant abutment screw

Kontact by Biotech Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental prosthesis/implant abutment screw.

Azure — TERRATS MEDICAL SL. · Class II
Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
KLOCKNER — SOADCO, S.L. · Class II
DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
Implant Prosthetics — PREAT Corporation · Class II
INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
MEDENTiKA — Medentika GmbH · Class II
Azure — TERRATS MEDICAL SL. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Biotech Dental

Sources (1)

FDA UDI bc1f0468-9d8b-40c4-b6e5-fb672d61b6a8 35 fields · synced May 30, 2026