Duns Number:315731711
Device Description: 3M™ ESPE™ Sinfony™ Opaquer Powder A3 Shade Dispenser Refill, 49620
Catalog Number
49620
Brand Name
Sinfony™
Version/Model Number
49620
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
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
421536c0-d0b1-4179-ae99-cd4f47f4f229
Public Version Date
September 21, 2018
Public Version Number
5
DI Record Publish Date
August 04, 2017
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 | 232 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 563 |
| U | Unclassified | 3 |