TRUBYTE SOFT RELINE SYSTEM
K964040 · Dentsply Intl. · EBI · Dec 6, 1996 · Dental
Device Facts
| Record ID | K964040 |
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| Device Name | TRUBYTE SOFT RELINE SYSTEM |
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| Applicant | Dentsply Intl. |
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| Product Code | EBI · Dental |
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| Decision Date | Dec 6, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 872.3760 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended 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.
Indications for Use
Indicated for patients requiring long-term resilient lining for removable dentures.
Regulatory Classification
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)
- Molloplast B (Unknown)
- PermaSoft (K933468)
Reference Devices
- Triad® DuaLine™ Material (K926406)
- Lucitone® 199 Denture Base (Pre-1976)
- Precise™ Denture Base (K952351)
- Kadon (Pre-1976)
Related Devices
- K112445 — SOFRELINER TOUGH S · Tokuyama Dental Corporation · Oct 28, 2011
- K111178 — JUELL SOFT CURE · Juell Dental · Sep 12, 2011
- K981691 — SILICONE SOFT RELINE · Harry J. Bosworth Co. · Nov 3, 1998
- K060844 — SILKLINE SOFT RELINING KIT, MODEL 28-100100 · J. Morita USA, Inc. · Jun 6, 2006
- K153253 — GC Reline II · GC America, Inc. · Mar 3, 2016
Submission Summary (Full Text)
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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).
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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.
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