Neodent - Healing GM 6.5 - JJGC Indústria e Comércio de Materiais Dentários S/A.

Duns Number:906713888

Device Description: Healing GM 6.5

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More Product Details

Catalog Number

106255

Brand Name

Neodent

Version/Model Number

106255

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

K163194

Product Code Details

Product Code

NHA

Product Code Name

Abutment, implant, dental, endosseous

Device Record Status

Public Device Record Key

928be8d9-80d4-4b3d-9881-9defb1586603

Public Version Date

May 12, 2022

Public Version Number

1

DI Record Publish Date

May 04, 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