Neodent

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name: Neodent FDA UDI
Generic Name: Dental implant internal thread shaping tool FDA UDI
Device Name: RECTIFIER SET FDA UDI
Model / Reference: 130.017 FDA UDI
Description: RECTIFIER SET FDA UDI

Identifiers

Catalog Number: 130.017 FDA UDI
Primary DI / UDI-DI: 07899878011187 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental implant internal thread shaping tool FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

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 — 1.6 Millimeter FDA UDI

Category: Dental implant internal thread shaping tool

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

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Also classified as Dental implant internal thread shaping tool.

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MEDENTiKA — Medentika GmbH · Class I
MEDENTiKA — Medentika GmbH · Class I
MEDENTiKA — Medentika GmbH · Class I
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: JJGC Indústria e Comércio de Materiais Dentários S/A.

Sources (1)

FDA UDI c197d33c-e1b0-4029-89f7-380fb188f891 37 fields · synced May 30, 2026