TRI-PHASIX CHROMATIC ALGINATE

K962741 · Parkell, Inc. · ELW · Sep 6, 1996 · Dental

Device Facts

• Record ID: K962741
• Device Name: TRI-PHASIX CHROMATIC ALGINATE
• Applicant: Parkell, Inc.
• Product Code: ELW · Dental
• Decision Date: Sep 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

The product is intended for use as impression material as defined in §872.3660 of CFR 21, "to reproduce the structure of a patient's teeth and gums ... to provide models for study and for production of restorative prosthetic devices," etc.

Device Story

Vanilla-flavored chromatic alginate impression material; changes color (violet to pink to white) to indicate mixing completion, tray loading readiness, and impressioning readiness. User-adjustable water-to-powder ratios allow for heavy, medium, or light body consistencies. Used by dental professionals in clinical settings to capture dental anatomy; output is a physical impression used to create gypsum models for study or prosthetic restoration. Benefits include visual cues for optimal handling and 50-micron detail reproduction.

Clinical Evidence

Bench testing only. Complies with ISO 1563/1990. Reproduces 50-micron detail. Mixing time 45 seconds; total working time 2 minutes 25 seconds.

Technological Characteristics

Chromatic alginate impression material; vanilla flavored. Complies with ISO 1563/1990. Compatible with dental model gypsum. Reproduces 50-micron detail.

Indications for Use

Indicated for dental patients requiring impressions of teeth and gums for study models or restorative prosthetic device fabrication.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Chromaclone Color Changing Alginate
• Orthalgenat Impression Material
• Algidenco
• Algiprint Impress Material
• Dental Alginate Impression Material
• Proof Alginate Impression Material
• Cutter-Jel Alginate Impression Material

Submission Summary (Full Text)

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K 962741
SEP - 6 1996
parkell

# 510(k) SUMMARY

## Submitter:
Nelson J. Gendusa, DDS
Director of Research
Parkell Products, Inc.
155 Schmitt Blvd.
Farmingdale, NY 11735
TEL: [phone]
FAX: [phone]

## Contact:
Same as above

## Date of Submission:
July 9, 1996

## Trade Name:
Parkell TriPhasix Chromatic Alginate

## Common Name:
Alginate Impression Material

## Classification Name:
Impression Material (21 CFR §872.3660)

## Equivalence:
Chromaclone Color Changing Alginate Orthalgenat Impression Material Algidenco and Algiprint Impress Material Dental Alginate Impression Material Proof Alginate Impression Material Cutter-Jel Alginate Impression Material

## Description and Intended Use:
TriPhasix Chromatic Alginate may be described as a vanilla flavored alginate impression which changes color from violet to pink to white to indicate completion of mixing, appropriate consistency for tray loading and appropriate consistency for impressioning, respectively. Slight alteration of water-to-powder ratios will deliver "heavy", "medium", or "light" body mixtures as preferred by the user. The product is intended for use as impression material as defined in §872.3660 of CFR 21, "to reproduce the structure of a patient's teeth and gums ... to provide models for study and for production of restorative prosthetic devices," etc.

The above-cited material complies with ISO 1563/1990 FOR ALGINATE. It contains no hazardous materials. Mixing time is 45 seconds. Total working time is 2 minutes 25 seconds. It is compatible with dental model gypsum and reproduces 50 micron detail.

155 Schmitt Blvd. • P.O. Box 376 • Farmingdale, New York 11735 U.S.A.
Phone: [phone] • Fax: [phone]