Duns Number:001006089
Device Description: Jumbo Kit: 2 x 25 mL syringes gel (64 gm), 5 x 3 mL empty syringes, 50 applicator tips37% Jumbo Kit: 2 x 25 mL syringes gel (64 gm), 5 x 3 mL empty syringes, 50 applicator tips37% Phosphoric Acid
Catalog Number
-
Brand Name
ETCH ROYALE™ DENTAL ETCHING GEL
Version/Model Number
ER50
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
78395b5d-fdb4-4140-b49f-0b1a617af0c1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 11, 2016
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |