Neodent - DRIVE SMART IMPLANT - JJGC Indústria e Comércio de Materiais Dentários S/A.

Duns Number:906713888

Device Description: DRIVE SMART IMPLANT

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More Product Details

Catalog Number

109.790

Brand Name

Neodent

Version/Model Number

109.790

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

K133510

Product Code Details

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Record Status

Public Device Record Key

0ca2145e-d6a4-461b-9744-19095560ab07

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2015

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