(59 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a dental relining system, with no mention of AI or ML.
No.
The device is a material for relining dentures, which is a structural and supportive purpose rather than a direct therapeutic intervention for a disease or condition.
No
The device text describes a material used for relining removable dentures, focusing on its physical properties and biocompatibility. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly outlines physical components (silicone putty, liquid bonder, liquid solvent) and a manufacturing process involving heat polymerization and bonding. This is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use as a long-term resilient lining material for removable dentures." This describes a material used on a medical device (dentures) within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The components are materials used to create a physical lining for dentures (silicone putty, bonder, adhesive remover). They are not reagents, instruments, or software designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
- Performing tests in a laboratory setting
The device is a material used in the fabrication and maintenance of dentures, which are medical devices, but the material itself is not an IVD.
N/A
Intended Use / Indications for Use
The TRUBYTE® SOFT RELINE SYSTEM is for use as a long-term resilient lining material for removable dentures.
Product codes
Not Found
Device Description
The TRUBYTE® SOFT RELINE SYSTEM consists of three components: TRUBYTE® Soft Reline Material, TRUBYTE® Soft Reline Bonder, and TRUBYTE® Adhesive Remover.
TRUBYTE® Soft Reline Material is a silicone putty that is heat polymerizable. It is a one-component material based on an elastomer and benzoyl peroxide.
TRUBYTE® Soft Reline 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 Reline Material is bonded to the denture with the TRUBYT® Soft Reline Bonder, packed and compressed, and then heat cured. TRUBYTE Adhesive Remover is used to clean an existing denture prior to relining. The Adhesive is completely eliminated prior to using Soft Reline Material and Bonder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
New Per-Fit Improved K901621, Molloplast B Unknown, PermaSoft K933468
Reference Device(s)
Triad DuaLine™ Material (K926406), Lucitone® 199 Denture Base (Pre-1976 Device), Precise™ Denture Base (K952351), Kadon (Pre-1976 Device)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
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.(b)
Classification. Class II.
0
510(k) SUMMA DFC - 6 1996
Page 1 of 2
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 7171845-7511 Fax 17171 854-2343 P. J. Lehn Telefax
CONTACT : P. Jeffery Lehn DATE PREPARED:
September 26, 1996
TRUBYTE® SOFT RELINE SYSTEM TRADE NAME:
CLASSIFICATION NAME: Relining, repairing or rebasing denture base resin
PREDICATE DEVICES: New Per-Fit Improved K901621 Molloplast B Unknown PermaSoft K933468
The TRUBYTE® SOFT RELINE SYSTEM consists of three DEVICE DESCRIPTION: TRUBYTE® Soft Reline Material, TRUBYTE® Soft Reline Bonder, and components: TRUBYTE® Adhesive Remover.
TRUBYTE® Soft Reline Material is a silicone putty that is heat polymerizable. It is a one-component material based on an elastomer and benzoyl peroxide.
TRUBYTE® Soft Reline 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 Reline Material is bonded to the denture with the TRUBYT® Soft Reline Bonder, packed and compressed, and then heat cured. TRUBYTE Adhesive Remover is used to clean an existing denture prior to relining. The Adhesive is completely eliminated prior to using Soft Reline Material and Bonder.
The TRUBYTE® SOFT RELINE SYSTEM is for use as a long-term INTENDED USE: 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).
LI
1
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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