Neodent

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 111.048Model Instrument

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

Identity

Trade Name: Neodent FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: Drilling Instruments EUDAMED
BONE TAP FOR ZIRCONIA IMPLANT FDA UDI
Model / Reference: 111.048 EUDAMEDFDA UDI
Instrument EUDAMED
Description: BONE TAP FOR ZIRCONIA IMPLANT FDA UDI

Identifiers

Catalog Number: 111.048 FDA UDI
Primary DI / UDI-DI: 07899878053484 EUDAMEDFDA UDI
Basic UDI-DI: 987800043VH EUDAMED
FDA Product Code: NDP FDA UDI
EMDN Code: L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term: Bone tap, reusable FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA 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

Dimensions & Sizes

Size: Outer Diameter — 4.3 Millimeter FDA UDI

Category: Bone tap, reusable

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 Bone tap, reusable.

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Insite — TORNIER, INC. · Class I
ReLine — Nuvasive, Inc. · Class I
Mariner MIS — SeaSpine Orthopedics Corporation · Class I
Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I

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 1e74d395-01ec-4000-92f2-4c35b3dc3b83 37 fields · synced Jul 17, 2026
EUDAMED 5a8a21fb-b6cc-4547-a49d-b4eb81c577b4 61 fields · synced Jul 17, 2026