← Product Code [ELW](/productcode/ELW) · K964692 # PERFECTIM (K964692) _J. Morita USA, Inc. · ELW · Feb 25, 1997 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K964692 ## Device Facts - **Applicant:** J. Morita USA, Inc. - **Product Code:** [ELW](/productcode/ELW.md) - **Decision Date:** Feb 25, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use To take dental impressions. ## Device Story Perfectim is a line of vinyl polysiloxane dental impression materials used by dental professionals to capture intraoral impressions. The system consists of a polymer, crosslinker, and platinum complex, with various fillers (e.g., silica, barium sulfate, magnesium silicate, Aerosil) added to adjust viscosity, rheology, thixotropy, and durometer. The material is applied intraorally to record dental structures; it sets to form a stable mold. The thixotropic properties prevent uncontrolled flow, reducing patient gagging. After removal, the impression is disinfected using hospital-level disinfectants or aqueous sterilants to prevent cross-contamination between the dental office and the laboratory. The device provides high dimensional stability and tear strength, facilitating the fabrication of accurate dental restorations or appliances. ## Clinical Evidence No clinical data provided. The device relies on established scientific evaluations and the long-standing history of vinyl polysiloxane impression materials in dentistry since 1973. Safety is supported by the lack of reported adverse reactions in dental and other health-related applications. ## Technological Characteristics Vinyl polysiloxane impression material consisting of a polymer, crosslinker, and platinum complex. Fillers include silica (crystalline, amorphous, fumed, diatomaceous), barium sulfate for radiopacity, and magnesium silicate/Aerosil for thixotropy. Material properties (viscosity, durometer, elasticity, tear strength) are tuned via filler selection. The system is chemically stable and compatible with hospital-level disinfectants and aqueous sterilants. ## Regulatory Identification Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. ## Special Controls *Classification.* Class II (Special Controls). ## Predicate Devices - Blue Velvet ([K930248](/device/K930248.md), [K871409](/device/K871409.md), [K781083](/device/K781083.md)) - 30 Second Blue Velvet ([K930248](/device/K930248.md), [K871409](/device/K871409.md), [K781083](/device/K781083.md)) - Flexi-Velvet ([K930248](/device/K930248.md), [K871409](/device/K871409.md), [K781083](/device/K781083.md)) - Single Phase Body ([K872745](/device/K872745.md), [K871409](/device/K871409.md), [K781083](/device/K781083.md)) - Final Wash ([K801380](/device/K801380.md), [K871409](/device/K871409.md), [K781083](/device/K781083.md)) - Preliminary Phase ([K930248](/device/K930248.md), [K871409](/device/K871409.md), [K781083](/device/K781083.md)) - Secondary Wash ([K801380](/device/K801380.md), [K871409](/device/K871409.md), [K781083](/device/K781083.md)) - Putty ([K801380](/device/K801380.md), [K781083](/device/K781083.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} K96469Z rlc 25 1997 # J.MORITA USA ## 510(k) Summary The following summary regarding 510(k) safety and effectiveness information for the Perfectim dental impression materials device, regulated under 21 C.F.R. Section 872.3660, was prepared November 4, 1996 and is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 and 21 C.F.R. Section 807.92. ## Applicant: J.Morita USA, Inc. 14712 Bentley Circle Tustin, California 92680 Contact Person: Terry G. Mahn Fish & Richardson 601 13th Street, N.W. Suite 500 North Washington, D.C. 20005 Phone: (202) 783-5070 Fax: (202) 783-2331 ## Classification Name: Impression material ## Usual Name: Dental impression material ## Proprietary Name: Perfectim J.MORITA CORPORATION 14712 BENTLEY CIRCLE, TUSTIN, CA 92780 • (714) 544-2854 • FAX (714) 730-1048 {1} # Predicate Devices The Perfectim line of dental impression materials have the same technological, safety, and effectiveness characteristics, and are substantially equivalent to, the following predicate devices: | PERFECTIM PRODUCT | PREDICATE DEVICE | | --- | --- | | Blue Velvet | K930248; K871409; K781083 | | 30 Second Blue Velvet | K930248; K871409; K781083 | | Flexi-Velvet | K930248; K871409; K781083 | | Single Phase Body | K872745; K871409; K781083 | | Final Wash | K801380; K871409; K781083 | | Preliminary Phase | K930248; K871409; K781083 | | Secondary Wash | K801380; K871409; K781083 | | Putty | K801380; K781083 | # Intended Use To take dental impressions. # Description of Device This 510(k) application is for a line of dental impression materials. Vinyl polysiloxane impression materials have been used in the dental field since 1973. There are presently at least twelve manufacturers worldwide of this type impression material and more than 30 companies selling impression products under private label. Based upon the total impression market, which would include all types of impression materials used, the vinyl addition products have gained the majority share according to current trade reports. Clinical studies as well as scientific evaluations have shown that the handling characteristics and the physical properties of the vinyl polysiloxane impression materials are superior to all previous impression materials. With the many impression techniques that are used in dentistry today, the vinyl addition system manufacturers have developed a great variety of different materials to satisfy these diverse requirements. To create these various viscosities and rheological changes in the vinyl system, the type of filler used is changed. Radiopacity can be added by using a small percentage of barium sulfate in the filler addition (K872745, July 1987). Thixotropy to overcome the uncontrolled flow of impression materials which can cause gagging can be accomplished by altering the filler system. Instead of using extending fillers, bulking fillers are used. Aeorsil is an example of such a filler. Fillers generally are not involved in the chemical reaction between the polymer, crosslinker and platinum complex. The filler particles interspersed between the silicone rubber matrix can alter the viscosity and durometer as well as the elasticity and tear strength of the set material. The efficacy and safety of the product is not altered since the addition silicone reaction is not dependent on the fillers used. The excellent dimensional stability of the vinyl system is also unaffected. {2} The available fillers that can be used in formulating vinyl polysiloxane impression systems are numerous and each one has a specific characteristic. For example, silica is available in several forms. The crystalline type, the amorphous type, the fumed type or the diatomaceous type all have different characteristics when used in system design. When more than one silica is used in a system the change in rheology can be as a result of the properties imparted by each filler. A further filler that can be used is combining the fumed silica with magnesium silicate, creating a rheologically altered impression material that is very thixotropic, yet fluffy and non-flowing except when some external force is applied. The resultant material can be used for impressions without the inconvenience of uncontrolled flow, which in many instances cause gagging. Vinyl addition silicone products are used in other health related fields such as rehabilitation and occupational therapy for scar control after primary wound healing and in hearing restoration with externally worn hearing aids by the use of impressions of the outer and part of the middle ear. To our knowledge no reports have been published indicating any untoward reactions when vinyl polysiloxane materials are used in any application including the high volume usage in the dental field. When used intraorally in dentistry, the impression is contaminated with saliva and blood. Vinyl addition impressions can be disinfected with any hospital level disinfectant or aqueous sterilant to prevent the spread of pathogens from the dental office environment to the dental laboratory technician, thus eliminating possible cross contamination. --- **Source:** [https://fda-staging.innolitics.com/device/K964692](https://fda-staging.innolitics.com/device/K964692) **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. 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