Angulated Screwdriver

FDA UDI

Class I (US FDA UDI)

by Panthera Dentaire Inc

Identity

Trade Name: Angulated Screwdriver FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous dental implant. It is intended to be used with the following screw patterns: KCS FDA UDI
Model / Reference: KCS 20mm FDA UDI
Description: Reusable dental tool made of phynox and adapted to screw a Panthera Dental angulated screw channel device on an endo-osseous dental implant. It is intended to be used with the following screw patterns: KCS FDA UDI

Identifiers

Catalog Number: 34021 FDA UDI
Primary DI / UDI-DI: 07540204000169 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical screwdriver, 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

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

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

Angulated Screwdriver by Panthera Dentaire Inc — 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: Panthera Dentaire Inc

Sources (1)

FDA UDI 106aeef4-90a6-4cd5-bf61-1a5da54a8476 34 fields · synced May 30, 2026