Duns Number:435782248
Catalog Number
0120038
Brand Name
ACRY PLUS EVO
Version/Model Number
ACRY PLUS EVO 8 UPPER
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
PZY
Product Code Name
Additively Manufactured, Preformed, Resin Denture Tooth
Public Device Record Key
c7b57925-ed7f-4fb3-9e21-0073410fb875
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
February 26, 2020
Package DI Number
28056865012388
Quantity per Package
12
Contains DI Package
08056865012384
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-