Tri

FDA UDI

Class II (US FDA UDI)

by Tri Dental Implants Int. AG

Identity

Trade Name: TRI FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Model / Reference: A FDA UDI

Identifiers

Catalog Number: TV60-02 FDA UDI
Primary DI / UDI-DI: 07640149881608 FDA UDI
FDA Product Code: DZE FDA UDI
NHA FDA UDI
GMDN Term: Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
872.3630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

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: Screw endosteal dental implant, two-piece Fluted surgical drill bit, reusable

Tri by Tri Dental Implants Int. AG — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Tri Dental Implants Int. AG

Sources (1)

FDA UDI 7d44bcd5-ae51-4d24-ad52-9e5a3212c7a7 34 fields · synced May 30, 2026