Duns Number:119193803
Device Description: Tiny, non-stick Angle Compo-Dots foam sponges condense composites with no voids or open ma Tiny, non-stick Angle Compo-Dots foam sponges condense composites with no voids or open margins. Elastic memory provides an ideal compressive force and prevents "draw-back" of composite upon removal. Angled end is ideal for interproximal composite surfaces in Class II, III, and IV restorations, while concave end addresses Class V applications at the gumline.
Catalog Number
71-05714
Brand Name
Compo-Dots Composite Condensing Dots Angle
Version/Model Number
71-05714
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
8491a889-e67a-436d-b1e4-c01d0c6eaff7
Public Version Date
June 25, 2019
Public Version Number
1
DI Record Publish Date
June 17, 2019
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |