Tri

FDA UDI

Class II (US FDA UDI)

by Tri Dental Implants Int. AG

Identity

Trade Name: TRI FDA UDI
Generic Name: Dental implant system FDA UDI
Model / Reference: A FDA UDI

Identifiers

Catalog Number: TV10-41-F FDA UDI
Primary DI / UDI-DI: 07640149881271 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dental implant system

The TRI dental implant system is a high-quality, single-use dental implant solution designed for optimal support and retention of dental prostheses. Made from sterile endosteal materials and featuring a combination of surgical instruments, this system provides a reliable means of implantation and placement into the alveolar or basal bone of the mandible or maxilla.

Similar devices

Also classified as Dental implant system.

Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Implant Regular — BIO CONCEPT Co., Ltd. · Class II
Denture Retention Attachments — IMPLANT ATTACHMENTS LLC · 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 ba6f2819-61ae-4e28-990e-0e8967672186 34 fields · synced Jul 21, 2026