Elos Driver

FDA UDI

Class I (US FDA UDI)

by Elos Medtech Pinol A/S

Identity

Trade Name: Elos Driver FDA UDI
Generic Name: Surgical torque wrench adaptor FDA UDI
Device Name: A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures. FDA UDI
Model / Reference: C20895 FDA UDI
Description: A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures. FDA UDI

Identifiers

Primary DI / UDI-DI: 05712821007599 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical torque wrench adaptor 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical torque wrench adaptor

Elos Driver by Elos Medtech Pinol A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Elos Medtech Pinol A/S

Sources (1)

FDA UDI c5baceab-272c-458e-9a44-83c24b1f2b32 33 fields · synced Jun 6, 2026