Neodent

FDA UDI

Class II (US FDA UDI)

by JJGC Indústria e Comércio de Materiais Dentários S/A.

Identity

Trade Name: Neodent FDA UDI
Generic Name: Screw endosteal dental implant, one-piece FDA UDI
Device Name: GM TITAMAX ACQUA IMPLANT FDA UDI
Model / Reference: 140.918 FDA UDI
Description: GM TITAMAX ACQUA IMPLANT FDA UDI

Identifiers

Catalog Number: 140.918 FDA UDI
Primary DI / UDI-DI: 07899878024811 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, one-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 4 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI

Category: Screw endosteal dental implant, one-piece

Neodent by JJGC Indústria e Comércio de Materiais Dentários S/A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Zirlux — HENRY SCHEIN, INC. · Class II
KLOCKNER — SOADCO, S.L. · Class II
Tryon — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
KJ Mini Implant System — Kj Meditech · Class II
Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · 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: JJGC Indústria e Comércio de Materiais Dentários S/A.

Sources (1)

FDA UDI 910a0f94-ea5b-4463-8239-d6086bbdc8f4 37 fields · synced May 30, 2026