Who is the manufacturer of MYERSON'S ECONOMY DENTURE BASE MATERIAL?

Austenal, Inc. filed the 510(k) submission for MYERSON'S ECONOMY DENTURE BASE MATERIAL (K970522).

What is the FDA product code for MYERSON'S ECONOMY DENTURE BASE MATERIAL?

EBI. It is classified under 21 CFR 872.3760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for MYERSON'S ECONOMY DENTURE BASE MATERIAL?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MYERSON'S ECONOMY DENTURE BASE MATERIAL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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.

Related Devices

K220680 — Denture Base Polymers · Shandong Huge Dental Material Corporation · Aug 12, 2022
K102654 — VERTEX RAPID SIMPLIFIED · Vertex-Dental B.V. · Dec 3, 2010
K130076 — PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS · Merz Dental GmbH · Aug 22, 2013
K102874 — NEW STETIC ACRYLICS · New Stetic · Mar 28, 2011
K230115 — Denture Base Resin · Aidite (Qinhuangdao) Technology Co., Ltd. · Mar 17, 2023

Submission Summary (Full Text)

{0} AUSTENAL K970522 4101 W. 51ST STREET CHICAGO IL 60632-4287 TEL 312.735.0800 800.621.0381 FAX 312.735.3940 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.