SIC invent Dental Implant Systems

FDA UDI

Class I (US FDA UDI)

by SIC invent AG

Identity

Trade Name: SIC invent Dental Implant Systems FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Device Name: SIC Extension Drill Ø 3.75 mm for Depth Stop FDA UDI
Model / Reference: 935220 FDA UDI
Description: SIC Extension Drill Ø 3.75 mm for Depth Stop FDA UDI

Identifiers

Primary DI / UDI-DI: 04260516870900 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Fixture/appliance dental drill bit, 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

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fixture/appliance dental drill bit, reusable

SIC invent Dental Implant Systems by SIC invent AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Fixture/appliance dental drill bit, reusable.

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Prima Plus — Keystone Dental Inc. · Class I
FTN Tapered Drill — DIO Corporation · Class I
Prima — Keystone Dental Inc. · Class I
Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
Stopper Drill — Megagen Implant Co. Ltd · Class I

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: SIC invent AG

Sources (1)

FDA UDI 8b52e80e-c668-46f8-915c-106094a5033a 34 fields · synced May 31, 2026