NobelProcera® - NobelProcera® Zirconia Abutment NB N1™ Base A1 RP - Nobel Biocare AB

Duns Number:353939929

Device Description: NobelProcera® Zirconia Abutment NB N1™ Base A1 RP

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More Product Details

Catalog Number

87146

Brand Name

NobelProcera®

Version/Model Number

87146

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

c7acea08-6c3c-4c5e-9dfa-57e52f3d40c4

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOBEL BIOCARE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 782
2 A medical device with a moderate to high risk that requires special controls. 3680