Duns Number:119193803
Device Description: Original Amalgam Catches "convert" a mouth mirror into a collection cup that helps prevent Original Amalgam Catches "convert" a mouth mirror into a collection cup that helps prevent amalgam debris from falling down the throat. Plastic clip-on design reduces mirror fogging by shielding the glass from the patient's breath. Adds revenue by increasing valuable scrap recovery and recycling too
Catalog Number
70-14420
Brand Name
Amalgam Catches
Version/Model Number
70-14420
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIF
Product Code Name
Accessories, Retractor, Dental
Public Device Record Key
50f266ad-c3b4-4617-ac0b-751351d51365
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 11, 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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |