Tri

FDA UDI

Class II (US FDA UDI)

by Tri Dental Implants Int. AG

Identity

Trade Name: TRI FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Model / Reference: A FDA UDI

Identifiers

Catalog Number: SCRW-3.25 FDA UDI
Primary DI / UDI-DI: 07640149886276 FDA UDI
FDA Product Code: NHA FDA UDI
DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Screw endosteal dental implant, two-piece

This sterile dental implant device, screw endosteal type, is designed for single-tooth or overdenture applications. It provides a means of support and retention for dental prostheses in the form of two pieces: an anchorage component (implant body) implanted into bone and a retention component (implant abutment) attached to the anchorage component after implantation.

Similar devices

Also classified as Screw endosteal dental implant, two-piece.

ET III NH Ultra-Wide Fixture No-Mount — HIOSSEN INC. · Class II
SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD. · Class II
LW Solid Abutment — Ossvis Co., Ltd. · Class II
LW Vis Abutment — Ossvis Co., Ltd. · Class II
s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
LW Vis Abutment — Ossvis Co., Ltd. · Class II
PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II

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 0a98fa59-2cbe-415f-8889-b07764da854a 33 fields · synced Aug 3, 2026