Neodent

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 105.162Model Instrument

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

Identity

Trade Name: Neodent FDA UDI
Generic Name: Dental implant system FDA UDI
Device Name: Manual Connections and Screwdrivers EUDAMED
NGS GM NARROW DRIVER FOR TORQUE WRENCH FDA UDI
Model / Reference: Instrument EUDAMED
105.162 EUDAMED
105162 FDA UDI
Description: NGS GM NARROW DRIVER FOR TORQUE WRENCH FDA UDI

Identifiers

Catalog Number: 105.162 FDA UDI
Primary DI / UDI-DI: 07899878046899 EUDAMEDFDA UDI
Basic UDI-DI: 987800068VZ EUDAMED
FDA Product Code: NDP FDA UDI
EMDN Code: P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term: Dental implant system FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.3980 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5 Millimeter FDA UDI

Category: Dental implant system

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

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
TRI — Tri Dental Implants Int. AG · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
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 (2)

FDA UDI 685356d5-3b3c-496f-aead-3d0e2abe46c0 37 fields · synced Jun 18, 2026
EUDAMED 9bbb29e5-dcb7-42e8-a4aa-ee3484512c77 61 fields · synced Jun 18, 2026