Kontact

FDA UDI

Class I (US FDA UDI)

by Biotech Dental

Identity

Trade Name: KONTACT FDA UDI
Generic Name: Dental implant system FDA UDI
Device Name: Drill Stop Ø5.4mm L08mm short drill and L12mm long drill FDA UDI
Model / Reference: KB54C8L12 FDA UDI
Description: Drill Stop Ø5.4mm L08mm short drill and L12mm long drill FDA UDI

Identifiers

Catalog Number: KB54C8L12 FDA UDI
Primary DI / UDI-DI: 03701045241263 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental implant system 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

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 implant system

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

Similar devices

Also classified as Dental implant system.

Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Implant Regular — BIO CONCEPT Co., Ltd. · Class II
TRI — Tri Dental Implants Int. AG · 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 a8f6ae13-d467-49a6-9717-3f1b0490d389 35 fields · synced May 31, 2026