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: TV40-01 FDA UDI
Primary DI / UDI-DI: 07640149881332 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

Yes

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

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 8978429c-3fb2-4e14-a359-03b9eba9c0ba 34 fields · synced May 31, 2026