Duns Number:690922612
Device Description: Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a dent Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Light Pink.
Catalog Number
TS01US
Brand Name
Acrylic Block
Version/Model Number
MCL-010-A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2018
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
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
8e2c11f2-e526-46c6-a556-0c049178d39a
Public Version Date
August 02, 2019
Public Version Number
4
DI Record Publish Date
November 07, 2016
Package DI Number
24560227799007
Quantity per Package
4
Contains DI Package
14560227799000
Package Discontinue Date
May 01, 2018
Package Status
Not in Commercial Distribution
Package Type
Cardboard
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |