MYERSON'S ECONOMY DENTURE BASE MATERIAL

K970522 · Austenal, Inc. · EBI · May 14, 1997 · Dental

Device Facts

• Record ID: K970522
• Device Name: MYERSON'S ECONOMY DENTURE BASE MATERIAL
• Applicant: Austenal, Inc.
• Product Code: EBI · Dental
• Decision Date: May 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Myerson Economy Denture Base Material is intended for use in the fabrication of full and partial dentures.

Device Story

Conventional dough pack heat cure denture base material; consists of polymethyl methacrylate polymer powder and methyl methacrylate monomer; includes crosslinker (EGDMA or TEGDMA) and UV light absorber; pigments simulate gum tissue color. Used by dental laboratory technicians to fabricate prosthetic dentures. Output is a cured denture base. Benefits include restoration of oral function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

No clinical data; safety and effectiveness supported by dental literature and compliance with ADA standards.

Technological Characteristics

Dough pack heat cure denture base material; polymethyl methacrylate polymer; methyl methacrylate monomer; EGDMA or TEGDMA crosslinker; 0-1% UV light absorber; FDA-approved pigments. Complies with ADA standards for denture base materials.

Indications for Use

Indicated for patients requiring full or partial dentures.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Submission Summary (Full Text)

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AUSTENAL K970522

4101 W. 51ST STREET

CHICAGO IL 60632-4287

TEL [phone]

800.621.0381

FAX [phone]

MAY 14 1997

# 510(k) Notification Summary—Myerson Economy Denture Base Material

Myerson Economy Denture Base Material is intended for use in the fabrication of full and partial dentures.

The Myerson Economy Denture Base Material is a conventional dough pack heat cure denture base material that consists of a polymethyl methacrylate polymer powder with a heat cure monomer consisting of methyl methacrylate, crosslinker (either EGDMA or TEGDMA), 0-1% UV Light Absorber.

The polymer is shaded to simulate the color of gum tissue using pigments that appear on the FDA list of approved products.

This product is substantially equivalent to predicate denture base systems currently on the market which are either pre-amendment devices marketed via 510(K) notification.

The safety and effectiveness of these systems are well documented in the dental literature and the subject products have been formulated to comply with the applicable American Dental Association Standards for denture base materials and refine and repair denture base materials.