AccessGUDID - DEVICE: Roetzer Posterior Packer Sculptor (PPS) Instrument (00723896008782)

GUDID

Device Identifier (DI) Information

Brand Name: Roetzer Posterior Packer Sculptor (PPS) Instrument
Version or Model: 7129540
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-29540
Company Name: PRACTICON, INC.

Primary DI Number: 00723896008782
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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