IDS Insight Dental Implant System

FDA UDI

Class II (US FDA UDI)

by Titan Implant Systems, Llc

Identity

Trade Name: IDS Insight Dental Implant System FDA UDI
Generic Name: Dental implant system FDA UDI
Device Name: 3.8x8mm Tissue Level Finished System FDA UDI
Model / Reference: 380108 FDA UDI
Description: 3.8x8mm Tissue Level Finished System FDA UDI

Identifiers

Primary DI / UDI-DI: 00855992007151 FDA UDI
FDA Product Code: DZE FDA UDI
NHA FDA UDI
NDP FDA UDI
GMDN Term: Dental implant system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
872.3630 FDA UDI
872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 8 Millimeter FDA UDI
Width — 3.8 Millimeter FDA UDI

Category: Dental implant system

IDS Insight Dental Implant System by Titan Implant Systems, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant system.

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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
TRI — Tri Dental Implants Int. AG · 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: Titan Implant Systems, Llc

Sources (1)

FDA UDI 5fbff67b-e72a-4c15-a9dc-543bb09a60f5 35 fields · synced May 30, 2026