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: Surgical drill guide, single-use FDA UDI
Device Name: GUIDE AND REMOVER FOR WS CM ZYGOMA FRACTURED THREAD FDA UDI
Model / Reference: 130.104 FDA UDI
Description: GUIDE AND REMOVER FOR WS CM ZYGOMA FRACTURED THREAD FDA UDI

Identifiers

Catalog Number: 130.104 FDA UDI
Primary DI / UDI-DI: 07899878042310 FDA UDI
FDA Product Code: DZA FDA UDI
GMDN Term: Surgical drill guide, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4130 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

Category: Surgical drill guide, single-use

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

Similar devices

Also classified as Surgical drill guide, single-use.

MEDENTiKA — Medentika GmbH · Class I
Nobel Biocare® — Nobel Biocare AG · Class I
Arthrex® — Arthrex, Inc. · Class I
ALARA® 11 Gauge Access Needle with Sheath - Diamond Tip — SURGENTEC LLC · Class I
MEDENTiKA — Medentika GmbH · Class I
Lightning Short Instruments — RESPONSIVE ORTHOPEDICS LLC · Class I
PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP. · Class I
DentaSwiss — Biodenta Swiss AG · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

FDA UDI ab2fd07b-1a91-48f4-9d2c-2d57f8d625da 36 fields · synced Jun 1, 2026