Matchmaker/Propaque Porcelain
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K960770 FDA 510(k)
- FDA Product Code
- ELL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3920 FDA 510(k)
- Regulation Number
- 872.3920 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Matchmaker/Propaque Porcelain is a dental porcelain material designed for dental restorations, specifically for use in teeth. Classified as a porcelain dental device, it is intended for applications requiring precise matching of natural tooth color and structure, ensuring aesthetic and functional integration within the oral cavity.
This device is supplied in multiple reference codes and is used in dental laboratories and clinics for fabricating porcelain restorations such as crowns, bridges, and veneers. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD authorization. The material is non-sterile and intended for single-use in dental procedures, with specific lot numbers and batch identifiers listed for traceability.
Frequently asked questions
What types of dental restorations can the Matchmaker/Propaque Porcelain be used for, and where is it typically applied?
The Matchmaker/Propaque Porcelain is specifically designed for fabricating dental restorations such as crowns, bridges, and veneers. It is intended for use in dental laboratories and clinics to create restorations that closely match the natural color and structure of teeth, ensuring both aesthetic and functional integration within the oral cavity.
Is the Matchmaker/Propaque Porcelain sterile when supplied, and how should it be handled to ensure proper use?
The Matchmaker/Propaque Porcelain is supplied in a non-sterile state, meaning it is not pre-sterilized for direct patient use. Since it is intended for single-use in dental procedures, it should be handled in a clean environment and used immediately after opening to avoid contamination. Each lot has unique identifiers for traceability, ensuring proper inventory and quality control.
What regulatory pathways has the Matchmaker/Propaque Porcelain undergone, and what does that mean for its use in clinical settings?
The Matchmaker/Propaque Porcelain has received FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for Class II dental devices. This classification means it has been evaluated for safety and effectiveness in dental restorations, allowing its use in clinical settings under established guidelines. The device is categorized under the Dental (DE) Advisory Committee and falls under product code ELL, which pertains to dental porcelain materials.
Are there multiple versions or sizes of the Matchmaker/Propaque Porcelain, and how are they differentiated?
Yes, the Matchmaker/Propaque Porcelain is supplied in multiple reference codes (e.g., 3038718579, 3009161350, etc.), which likely correspond to different shades, opacities, or formulations tailored for specific dental restoration needs. While the exact variations aren’t detailed here, these codes help clinicians and labs select the appropriate porcelain for precise color matching and structural integration in crowns, bridges, or veneers.
How should the Matchmaker/Propaque Porcelain be stored to maintain its integrity before use?
Since the porcelain is non-sterile and intended for single-use, it should be stored in a dry, clean environment away from direct sunlight or extreme temperatures to prevent degradation. Proper labeling and tracking of lot numbers ensures traceability, while sealed packaging helps preserve its properties until use. Always follow manufacturer guidelines for storage duration and conditions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K960770 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Davis Schottlander & Davis Ltd
- FDA Applicant
- Davis Schottlander & Davis, Ltd.
Sources (2)
- FDA 510(k) K960770 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026