SPARE SOFT RETENTION SPRING - SPARE SOFT RETENTION SPRING - SWEDEN & MARTINA SPA

Duns Number:433815198

Device Description: SPARE SOFT RETENTION SPRING

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More Product Details

Catalog Number

MOL2-CAP-TIT-1

Brand Name

SPARE SOFT RETENTION SPRING

Version/Model Number

MOL2-CAP-TIT-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K142242

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

b9998151-89ef-4782-8283-1d3be61b5291

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SWEDEN & MARTINA SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1248
2 A medical device with a moderate to high risk that requires special controls. 1062