Home › PRACTICON, INC. › Roetzer Posterior Packer Sculptor (PPS) Instrument
Roetzer Posterior Packer Sculptor (PPS) Instrument
PRACTICON, INC. · Model 7129540 · UDI-DI 00723896008782
10
510(k) clearances
663
Adverse events
2
Recalls
383
Facilities
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-12-22 | Ultradent Products, Inc. | Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through |
| 2011-12-12 | Ormco/Sybronendo | The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.