← Product Code [EIH](/productcode/EIH) · K961291 # FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS (K961291) _Dentsply Intl. · EIH · May 28, 1996 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K961291 ## Device Facts - **Applicant:** Dentsply Intl. - **Product Code:** [EIH](/productcode/EIH.md) - **Decision Date:** May 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.6660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS are for use with the Finesse™ Low-Fusing Porcelain System in conjunction with non-precious or noble or high noble alloys when used for conventional porcelain-fused-to-metal crowns, bridges or dental prostheses. ## Device Story Auxiliary dental porcelain products; mixtures of frits, opacifiers, and pigments; used with Finesse Low-Fusing Porcelain System. Components include opaque modifiers, opaque correction, dentin correction, stains, and glaze porcelains. Applied by dental technicians in laboratory settings to create varied fusion temperatures, translucencies, and colors for dental prostheses. Enhances aesthetic and functional properties of porcelain-fused-to-metal restorations. ## Clinical Evidence Bench testing only; physical properties meet ISO standards; toxicity testing based on predicate device data. ## Technological Characteristics Mixtures of silicate frits, opacifiers, and pigments. Includes opaque modifiers, opaque correction, dentin correction, stains, and glaze porcelains. Physical properties conform to ISO standards. ## Regulatory Identification Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish. ## Predicate Devices - Finesse™ Low-Fusing Porcelain System ([K954761](/device/K954761.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUMMARY K961291 DENTSPLY MAY 28 1996 NAME & ADDRESS: DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343 P. J. Lehn Telefax (717) 849-4343 CONTACT: P. Jeffery Lehn DATE PREPARED: April 2, 1996 TRADE OR PROPRIETARY NAME: FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS CLASSIFICATION NAME: Porcelain Powder for Clinical Use 872.6660 PREDICATE DEVICE: Finesse™ Low-Fusing Porcelain System K954761 DEVICE DESCRIPTION: The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS contain mixtures of frits, opacifiers and pigments in varied quantities to create an assortment of materials with a variety of fusion temperatures, translucencies and colors. They contain the same silicate frits and opacifiers, and some of the same pigments used in K954761. Additional pigments used are also used in predicate medical devices. The physical properties for FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS meet the appropriate ISO Standards. INTENDED USE: The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS are for use with the Finesse™ Low-Fusing Porcelain System in conjunction with non-precious or noble or high noble alloys when used for conventional porcelain-fused-to-metal crowns, bridges or dental prostheses. TECHNOLOGICAL CHARACTERISTICS: The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS consist of opaque modifiers, opaque correction, dentin correction and stains, and glaze porcelains. These porcelains are substantially equivalent to Finesse Low-Fusing Porcelains (K954761). All of the components in the FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS have been used in predicate medical devices. We believe that the prior use of the FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS components in predicate devices, the performance data, and the results of toxicity testing on the predicate device, support the safety and effectiveness of FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS for the intended uses. 000037 --- **Source:** [https://fda-staging.innolitics.com/device/K961291](https://fda-staging.innolitics.com/device/K961291) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com