TRUBYTE SOFT RELINE SYSTEM

K964040 · Dentsply Intl. · EBI · Dec 6, 1996 · Dental

Device Facts

• Record ID: K964040
• Device Name: TRUBYTE SOFT RELINE SYSTEM
• Applicant: Dentsply Intl.
• Product Code: EBI · Dental
• Decision Date: Dec 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• 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.

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)

Submission Summary (Full Text)

{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 [phone]

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