Neodent - NGM EXACT TITANIUM BASE - JJGC Indústria e Comércio de Materiais Dentários S/A.

Duns Number:906713888

Device Description: NGM EXACT TITANIUM BASE

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More Product Details

Catalog Number

135.420-ET

Brand Name

Neodent

Version/Model Number

135.420-ET

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K220251

Product Code Details

Product Code

NHA

Product Code Name

Abutment, implant, dental, endosseous

Device Record Status

Public Device Record Key

2d3d64de-bd9c-49d1-ad55-c15e0358a797

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S/A." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 2219