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
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
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
KMY
Product Code Name
Positioner, Tooth, Preformed
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |