Duns Number:036623932
Device Description: 37% Phosphoric Acid Etch designed to etch and prepare dentin and enamel. Standard Kit Inc 37% Phosphoric Acid Etch designed to etch and prepare dentin and enamel. Standard Kit Includes: (4) 1.2mL prefilled syringes & (25) 22ga Pre-bent tips.
Catalog Number
-
Brand Name
Best Etch
Version/Model Number
502115
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
K984503,K984503
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
a32a7055-e6e0-414e-9c78-aa63213b949b
Public Version Date
September 06, 2018
Public Version Number
1
DI Record Publish Date
August 06, 2018
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 | 316 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |
| U | Unclassified | 36 |