MATCHMAKER/PROPAQUE PORCELAIN

K960770 · Davis Schottlander & Davis, Ltd. · ELL · Nov 19, 1996 · Dental

Device Facts

• Record ID: K960770
• Device Name: MATCHMAKER/PROPAQUE PORCELAIN
• Applicant: Davis Schottlander & Davis, Ltd.
• Product Code: ELL · Dental
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.

Device Story

Feldspathic porcelain powder; mixed with liquid to form paste or supplied as pre-mixed paste; applied to metal sub-structure in layers (opaque, dentine, enamel) to replicate natural tooth aesthetics; fired in dental furnace under vacuum; used by dental technicians in laboratory settings to create crowns and bridges; provides aesthetic restoration for patients requiring dental prosthetics.

Clinical Evidence

Bench testing only. Conformance to ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material standard, including testing for flexural strength, chemical solubility, fired porosity, coefficient of expansion, glass transition temperature, and metallo-ceramic bond characterization.

Technological Characteristics

Feldspathic porcelain powder; conforms to ISO 9693:1991; supplied in opaque, dentine, and enamel layers; requires furnace firing; physical properties include specific coefficient of expansion and flexural strength per ISO standard.

Indications for Use

Indicated for use in dentistry as a metallo-ceramic restorative material for the fabrication of crowns and bridges to replicate natural tooth color layers.

Regulatory Classification

Identification

A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.

Predicate Devices

• Creation

Submission Summary (Full Text)

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K960770
NOV 19 1996
Schottlander

# 510(K) Notification for Matchmaker/Propaque Porcelain

## 7. 510(K) Summary of the safety and effectiveness information upon which the substantial equivalence determination for Matchmaker/Propaque porcelains are based

| Name of contact person: | Mr B D Schottlander |
| --- | --- |
| Date that Summary was prepared | 16 February 1996 |
| Trade name | Matchmaker/Propaque porcelains |
| Common name | Bonding porcelain or metallo ceramic |
| Classification name | 872.6660-porcelain powder for clinical use |

The legally marketed device to which we are claiming equivalence is called Creation.

The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.

Comparison to predicate device.

## Chemical Similarities

Both products are feldspathic porcelains conforming to ISO 9693:1991 and are used in dentistry for fusing to a metal frame work to form an enamel porcelain layer. Both products are supplied with different layers ie; opaque, dentine, enamel etc. in order to replicate different colour layers in a natural tooth. Both products fall within the same class and part numbers. Both products are claimed on the labelling and directions for use to have essentially the same properties and usage.

## Application Similarities

Both products are supplied as a powder for mixing together with a liquid to form a paste or as a pre-mixed paste. Both products are supplied with different layers ie; opaque, dentine, enamel etc. in order to replicate different colour layers in a natural tooth and these layers are built up and fired in a furnace in the same order and at similar temperatures (see also below).

## Performance similarities.

Both products have essentially the same firing characteristics including low temperature for insertion into the furnace, drying time, final temperature and requirement for vacuum. Both products are manufactured to conform to ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material. This standard specifies performance criteria such as flexural strength, chemical solubility, fired porosity, coefficient of expansion, glass transition temperature and metallo-ceramic bond characterisation.

From the above information it is concluded that Matchmaker/Propaque porcelain possess substantial equivalence to the predicate device.