Duns Number:315731711
Device Description: 3M™ ESPE™ Photac™ Fil Quick Aplicap™ Light-Cured Glass Ionomer Restorative Shade A1 Refill 3M™ ESPE™ Photac™ Fil Quick Aplicap™ Light-Cured Glass Ionomer Restorative Shade A1 Refill, 61010
Catalog Number
61010
Brand Name
Photac™ Fil Quick Aplicap™
Version/Model Number
61010
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
a1b33597-0d2a-42e1-8344-53e5e3510909
Public Version Date
September 21, 2018
Public Version Number
3
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 |