Duns Number:830016148
Device Description: 3M™ ESPE™ Paradigm™ MZ100 Blocks for CEREC™ System Refill, Shade A1, Size 10, 5 Blocks/Pac 3M™ ESPE™ Paradigm™ MZ100 Blocks for CEREC™ System Refill, Shade A1, Size 10, 5 Blocks/Pack, 2710A1-S
Catalog Number
2710A1-S
Brand Name
Paradigm™
Version/Model Number
2710A1-S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2021
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)
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
9848e684-ccd9-4550-9f61-133ea471f6fb
Public Version Date
June 30, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50605861012176
Quantity per Package
10
Contains DI Package
30605861012172
Package Discontinue Date
June 30, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |