Dental Putty Syringe 2.0cc - Synthetic bone void filler for dental applications - NOVABONE PRODUCTS, LLC

Duns Number:828813290

Device Description: Synthetic bone void filler for dental applications

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More Product Details

Catalog Number

NA1612

Brand Name

Dental Putty Syringe 2.0cc

Version/Model Number

NA1612

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

K100671

Product Code Details

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Device Record Status

Public Device Record Key

e8baaa5e-08b7-4b2d-9686-927b76a22d87

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVABONE PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 80