Duns Number:017524666
Device Description: Dental Implant Guide - Single Tooth Set
Catalog Number
D015-003-P
Brand Name
EZ Stent
Version/Model Number
D015-003-P
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
-
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
73524ae9-837f-481b-97c4-3d9b8a26ed85
Public Version Date
March 23, 2022
Public Version Number
1
DI Record Publish Date
March 15, 2022
Package DI Number
10814639020004
Quantity per Package
200
Contains DI Package
00814639020007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |