Implant Spacers - Implant Spacers Set#1- for approximating space - Suncoast Dental, Inc

Duns Number:078352849

Device Description: Implant Spacers Set#1- for approximating space between teeth and/or implants - 1.5, 2.0, 2 Implant Spacers Set#1- for approximating space between teeth and/or implants - 1.5, 2.0, 2.5, 3.0, 3.5, & 4.0mm

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More Product Details

Catalog Number

Implant Spacers Set #1

Brand Name

Implant Spacers

Version/Model Number

Implant Spacers Set#1

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

-

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

KMY

Product Code Name

Positioner, Tooth, Preformed

Device Record Status

Public Device Record Key

90d44582-d2c1-490c-9fe8-7852ef3ddb7d

Public Version Date

August 25, 2021

Public Version Number

2

DI Record Publish Date

April 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNCOAST DENTAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 405
2 A medical device with a moderate to high risk that requires special controls. 536