Identity

Trade Name
Neodent FDA UDI
Generic Name
Dental bridge, ceramic FDA UDI
Device Name
NEODENT DIGITAL CROWN, ZrO2 LT FDA UDI
Model / Reference
191.043 FDA UDI
Description
NEODENT DIGITAL CROWN, ZrO2 LT FDA UDI

Identifiers

Catalog Number
191.043 FDA UDI
Primary DI / UDI-DI
07899878018384 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental bridge, ceramic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental bridge, ceramic

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 bridge, ceramic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 8b1ec4be-c786-4e31-93ee-344a0cd8f9b7 36 fields · synced May 29, 2026