Duns Number:119193803
Device Description: Firm Compo-Dots help condense higher viscosity composites more easily. Ideal for use with Firm Compo-Dots help condense higher viscosity composites more easily. Ideal for use with Class I, II and III preps.
Catalog Number
71-05712
Brand Name
Compo-Dots Composite Condensing Dots Firm
Version/Model Number
13113
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
5a993053-ece9-4fa1-8c32-7e082b73e6e0
Public Version Date
November 08, 2018
Public Version Number
2
DI Record Publish Date
July 19, 2018
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 |