SDS1.2 - SDS1.2 healing cap-disc 9x12 - SDS Swiss Dental Solutions AG

Duns Number:487103033

Device Description: SDS1.2 healing cap-disc 9x12

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More Product Details

Catalog Number

-

Brand Name

SDS1.2

Version/Model Number

SDS1.2_HC-disc-9x12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K181953

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

51793562-1fa6-47b1-8f6c-e68081d66bd0

Public Version Date

August 13, 2020

Public Version Number

1

DI Record Publish Date

August 05, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SDS SWISS DENTAL SOLUTIONS AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 43