Duns Number:315731711
Device Description: 3M™ RelyX™ Fiber Post Drill, 56873, White, Size 0
Catalog Number
56873
Brand Name
3M™ RelyX™
Version/Model Number
56873
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
-
Product Code
DZA
Product Code Name
DRILL, DENTAL, INTRAORAL
Public Device Record Key
bf9cd277-a56a-4025-9ef4-df2fef8962eb
Public Version Date
September 06, 2022
Public Version Number
1
DI Record Publish Date
August 29, 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 | 232 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 563 |
| U | Unclassified | 3 |