Duns Number:320744915
Device Description: Automix-Dispenser Type 50 1:1. Suitable for Honigum Pro Mono, Honigum Pro Heavy, Honigum P Automix-Dispenser Type 50 1:1. Suitable for Honigum Pro Mono, Honigum Pro Heavy, Honigum Pro Heavy Scan, Honigum Mono, Honigum Heavy, O-Bite, O-Bite Scan, Honigum Pro Light, Honigum Light. Content: 1 dispenser.
Catalog Number
999507
Brand Name
Automix-Dispenser Type 50 1:1
Version/Model Number
999507
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
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
8289298a-ef5d-471a-ba69-35db511f87ec
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |