Duns Number:830016148
Device Description: 3M™ ESPE™ MDI Mini Dental Implant O-Ball Prosthetic Head - Collared Standard 2.1 x 10mm, I 3M™ ESPE™ MDI Mini Dental Implant O-Ball Prosthetic Head - Collared Standard 2.1 x 10mm, IOB-10
Catalog Number
IOB-10
Brand Name
3M™ ESPE™ MDI Collared Intermediate O-Ball
Version/Model Number
2.1 mm x 10 mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2021
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
713c0c48-731e-4b30-8886-11b2647695bd
Public Version Date
September 30, 2021
Public Version Number
3
DI Record Publish Date
October 23, 2015
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |