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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
Dental implant kit FDA UDI
Device Name
EASY PACK HELIX GM 3.75X8/SMART ABUTMENT 4.5X1.5 FDA UDI
Model / Reference
138.028 FDA UDI
Description
EASY PACK HELIX GM 3.75X8/SMART ABUTMENT 4.5X1.5 FDA UDI

Identifiers

Catalog Number
138.028 FDA UDI
Primary DI / UDI-DI
07899878052111 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Dental implant kit 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 3.75 Millimeter FDA UDI

Category: Dental implant kit

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

Similar devices

Also classified as Dental implant kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

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

Sources (1)

  • FDA UDI 4eb83850-aea2-468d-8dce-3f0370159786 37 fields · synced Jun 6, 2026