Roetzer Posterior Packer Sculptor (PPS) Instrument

FDA UDI

Class I (US FDA UDI)

by Practicon, Inc.

Identity

Trade Name: Roetzer Posterior Packer Sculptor (PPS) Instrument FDA UDI
Generic Name: Dental material application tool, single-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 7129540 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 71-29540 FDA UDI
Primary DI / UDI-DI: 00723896008782 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Dental material application tool, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental material application tool, single-use

Roetzer Posterior Packer Sculptor (PPS) Instrument by Practicon, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Practicon, Inc.

Sources (1)

FDA UDI 4c22fc7e-6bc8-40d1-af2a-b14023fc4ab6 34 fields · synced May 31, 2026