Duns Number:119193803
Device Description: create superior anatomical features for composite or amalgam restorations in less time and create superior anatomical features for composite or amalgam restorations in less time and with fewer instruments. Shape occlusal contours in composites before curing and reduce post-cure cutting for stronger restorations. Instrument features a 21B acorn burnisher on one end with two sizes of rounded pluggers on the other. Also excellent for shaping and burnishing amalgams. 3⁄8" diameter easy-grasp ultralight handle for maximum control and tactile sensitivity. 6-3⁄4" long. Fully sterilizable stainless steel.
Catalog Number
71-29540
Brand Name
Roetzer Posterior Packer Sculptor (PPS) Instrument
Version/Model Number
7129540
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
4c22fc7e-6bc8-40d1-af2a-b14023fc4ab6
Public Version Date
November 08, 2018
Public Version Number
2
DI Record Publish Date
July 19, 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 |