Duns Number:811180298
Device Description: Type I fast-setting and Type II normal-setting.454g bagTo take dental impressions in which Type I fast-setting and Type II normal-setting.454g bagTo take dental impressions in which fine details can be reproduced, existing in the oral cavity.
Catalog Number
-
Brand Name
MDC Dental
Version/Model Number
Max Print
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K011785
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
71596b2a-5b4f-4d47-9cff-a05cadb2220d
Public Version Date
January 28, 2022
Public Version Number
1
DI Record Publish Date
January 20, 2022
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |