Duns Number:005473608
Device Description: EQUIA® Forte Intro Kit (48 Capsules of B2, EQUIA Forte Coat, Cavity Conditioner, & accesso EQUIA® Forte Intro Kit (48 Capsules of B2, EQUIA Forte Coat, Cavity Conditioner, & accessories)
Catalog Number
452007
Brand Name
EQUIA®
Version/Model Number
452007
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
K091106,K091106
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
20ff4d27-2e04-4149-b7ec-4f8c5e5dfa2b
Public Version Date
July 21, 2022
Public Version Number
1
DI Record Publish Date
July 13, 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 | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |