← Product Code [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI) · K964040 # TRUBYTE SOFT RELINE SYSTEM (K964040) _Dentsply Intl. · EBI · Dec 6, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K964040 ## Device Facts - **Applicant:** Dentsply Intl. - **Product Code:** [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI.md) - **Decision Date:** Dec 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3760 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The TRUBYTE® SOFT RELINE SYSTEM is for use as a long-term resilient lining material for removable dentures. ## Device Story System comprises silicone putty (Soft Refine Material), methacrylate-based liquid (Soft Refine Bonder), and D-Limonene solvent (Adhesive Remover). Used by dental professionals to reline removable dentures. Process: clean denture with Adhesive Remover; apply Bonder; pack and compress silicone putty; heat cure. Provides resilient lining to improve denture fit and patient comfort. Components utilize established dental materials; safety validated via biocompatibility testing. ## Clinical Evidence Bench testing only. Biocompatibility testing performed: Cytotoxicity Elution Test, Primary Skin Irritation Study, Salmonella Mutagenicity Test, FHSA Regulation Acute Mucosal, and Kligman Maximization Study. Results confirmed material is non-cytotoxic, non-irritant, non-mutagenic, and non-sensitizer. ## Technological Characteristics Silicone elastomer putty (heat polymerizable); methacrylate monomer/polymer blend bonder; D-Limonene solvent. Heat-cured system. Materials previously used in predicate dental devices. ## Regulatory 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. ## Predicate Devices - New Per-Fit Improved ([K901621](/device/K901621.md)) - Molloplast B (Unknown) - PermaSoft ([K933468](/device/K933468.md)) ## Reference Devices - Triad® DuaLine™ Material ([K926406](/device/K926406.md)) - Lucitone® 199 Denture Base (Pre-1976) - Precise™ Denture Base ([K952351](/device/K952351.md)) - Kadon (Pre-1976) ## 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} K964040 DEC -6 1996 510(k) SUMMARY DENTSPLY 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: September 26, 1996 TRADE NAME: TRUBYTE® SOFT RELINE SYSTEM CLASSIFICATION NAME: Relining, repairing or rebasing denture base resin PREDICATE DEVICES: New Per-Fit Improved K901621 Molloplast B Unknown PermaSoft K933468 DEVICE DESCRIPTION: The TRUBYTE® SOFT RELINE SYSTEM consists of three components: TRUBYTE® Soft Refine Material, TRUBYTE® Soft Refine Bonder, and TRUBYTE® Adhesive Remover. TRUBYTE® Soft Refine Material is a silicone putty that is heat polymerizable. It is a one-component material based on an elastomer and benzoyl peroxide. TRUBYTE® Soft Refine Bonder is a heat polymerizable methacrylate monomer and methacrylate polymer blend liquid. TRUBYTE® Adhesive Remover is D-Limonene, a liquid food-grade solvent, intended for use in removing impression material tray adhesives. TRUBYTE® Soft Refine Material is bonded to the denture with the TRUBYTE® Soft Refine Bonder, packed and compressed, and then heat cured. TRUBYTE® Adhesive Remover is used to clean an existing denture prior to refining. The Adhesive is completely eliminated prior to using Soft Refine Material and Bonder. INTENDED USE: The TRUBYTE® SOFT RELINE SYSTEM is for use as a long-term resilient lining material for removable dentures. TECHNOLOGICAL CHARACTERISTICS: All of the components of the TRUBYTE® SOFT RELINE SYSTEM have been used in DENTSPLY predicate devices: Triad® DuaLine™ Material (K926406), Lucitone® 199 Denture Base (Pre-1976 Device), Precise™ Denture Base (K952351), and Kadon (Pre-1976 Device). 000013 {1} 510(k) SUMMARY (cont'd.) Page 2 of 2 # TRADE NAME: TRUBYTE® SOFT RELINE SYSTEM TRUBYTE® SOFT RELINE MATERIAL was evaluated and found to be non-cytotoxic, a non-irritant, non-mutagenic and a non-sensitizer. The following tests were performed on the MATERIAL: Cytotoxicity Elution Test, Primary Skin Irritation Study, Salmonella Mutagenicity Test, FHSA Regulation Acute Mucosal, and Kligman Maximization Study. The BONDER, used with the cured MATERIAL and Lucitone® 199 Denture Base, was tested by the Cytotoxicity Elution Test and found to be non-cytotoxic. We believe that the prior use of the TRUBYTE® SOFT RELINE SYSTEM's components in predicate devices, the performance data presented, and the results of toxicity and sensitization testing support the safety and effectiveness of TRUBYTE® SOFT RELINE SYSTEM for the intended use. 000014 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K964040](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K964040) **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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