N/A - Conometric Temporization Cap, Ø4.5/5.8, single - Dentsply Implants Manufacturing GmbH

Duns Number:344038836

Device Description: Conometric Temporization Cap, Ø4.5/5.8, single tooth

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More Product Details

Catalog Number

31072114

Brand Name

N/A

Version/Model Number

31072114

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

-

Product Code Details

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Record Status

Public Device Record Key

05e5ef5a-5a7e-4b01-ac93-563caaf34c3c

Public Version Date

November 26, 2020

Public Version Number

1

DI Record Publish Date

November 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY IMPLANTS MANUFACTURING GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1379
2 A medical device with a moderate to high risk that requires special controls. 2266