(36 days)
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No
The device description and performance studies focus on the chemical and mechanical properties of a traditional dental composite adhesive, with no mention of AI or ML.
No.
The device is an adhesive used to bond orthodontic brackets to teeth, which is a structural or supportive function, not a therapeutic one that treats or prevents a disease or condition.
No
The device is an adhesive used for bonding orthodontic brackets, not for diagnosing medical conditions.
No
The device description clearly describes a physical adhesive material (primer and base paste) used for bonding orthodontic brackets, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the adhesion of orthodontic brackets to acid etched enamel." This describes a physical process of bonding a medical device (orthodontic brackets) to a biological structure (tooth enamel).
- Device Description: The description details a dental adhesive system used for bonding brackets to teeth. It involves a chemical reaction (polymerization) that occurs in situ on the tooth surface.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health or condition. This device does not perform any such diagnostic testing on biological specimens.
The device is a dental adhesive used in a clinical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
ORTHO-ONE is indicated for the adhesion of orthodontic brackets to acid etched enamel.
Product codes
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Device Description
ORTHO-ONE is identical to the Predicate Device (Rely A.Bond). Bisco, Inc. manufacturers both products in the sam facility using the same Device Master Record. The comments noted above for the IDENTIFICATION OF THE PREDICATE DEVICE pertain to the applicant product. That is, the applicant product has solved one of the major complaints with one-step orthodontic adhesive systems, namely bond strength. It is formulated with a highly filled paste that combines with a unique primer to produce a bond strength to etched enamel that virtually eliminates bonding failures. The catalyst insures that the material reaches maximum bond strength within five minutes. The paste is comprised of a high percentage of small particles that result in a tacky consistency. Bracket flotation is said to be totally eliminated with Relv.A. The paste flows easily onto the bracket pad and spreads evenly under the pad upon placement.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The physical data and performance characteristics of ORTHO-ONE are statistically identical to RELY . A BOND as would be expected. The flexural modulus (4.2 GPa), diametral tensile strength (39 MPa), and compressive strength (266 MPa) are statistically indistinguishable for the predicate and applicant product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
0
K9629
510(k) SUMMARY
As Required By the Safe Medical Devices Act of 1990
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
PREDICATE DEVICE
RELY . A . BOND™
RELY • A•BOND is claimed to have solved one of the major complaints with one-step orthodontic adhesive systems, namely bond strength. It is formulated with a highly filled paste that combines with a unique primer to produce a bond strength to etched enamel that virtually eliminates bonding failures. The catalyst insures that the material reaches maximum bond strength within five minutes. The paste is comprised of a high percentage of small particles that result in a tacky consistency. Bracket flotation is said to be totally eliminated with Rely A.BOND. The paste flows easily onto the bracket pad and spreads evenly under the pad upon placement.
DESCRIPTION OF APPLICANT PRODUCT
ORTHO-ONE™
ORTHO-ONE is identical to the Predicate Device (Rely A.Bond). Bisco, Inc. manufacturers both products in the sam facility using the same Device Master Record. The comments noted above for the IDENTIFICATION OF THE PREDICATE DEVICE pertain to the applicant product. That is, the applicant product has solved one of the major complaints with one-step orthodontic adhesive systems, namely bond strength. It is formulated with a highly filled paste that combines with a unique primer to produce a bond strength to etched enamel that virtually eliminates bonding failures. The catalyst insures that the material reaches maximum bond strength within five minutes. The paste is comprised of a high percentage of small particles that result in a tacky consistency. Bracket flotation is said to be totally eliminated with Relv.A. The paste flows easily onto the bracket pad and spreads evenly under the pad upon placement.
INTENDED USES OF APPLICANT DEVICE
ORTHO-ONE is indicated for the adhesion of orthodontic brackets to acid etched enamel.
SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS
ORTHO-ONE and RELY . A.BOND (K875143) are identical products manufactured in the same facility using the same Device Master Record. ORTHO-ONE is a no-mix direct bonding orthodontic adhesive. The micromechanical bond to enamel utilizes the acid etch technique and Bisco's unique composite chemistry. ORTHO-ONE will bond to metal or plastic brackets without additional conditioners.
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BISCO, INC., 1500 W. Thorndate Ave., Itasca, IL 60143 510(k) submission for ORTHO-ONE
510(k) SUMMARY (continued) As Required By the Safe Medical Devices Act of 1990
SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS (continued)
ORTHO-ONE, unlike conventional dental adhesives, does not require mixing in the traditional sense. That is, one is not required to mix a base and a catalyst on a mixing pad and deliver the mixed material to the mouth. The product is a two part system employing a primer and an adhesive base paste. Without mixing, the primer is applied to the base paste is applied to the bracket. The orthodontist places the bracket against the tooth with a slight twisting motion causing the primer to activate the base paste, resulting in curing of the adhesive.
ORTHO-ONE is a traditional dental composite formulation utilizing a silica filled dimethacrylate resin base paste and an unfilled dimethacrylate primer. The adhesive cures through a conventional amine activated benzoyl peroxide initiated free radical addition polymerization.
The physical data and performance characteristics of ORTHO-ONE are statistically identical to RELY . A BOND as would be expected. The flexural modulus (4.2 GPa), diametral tensile strength (39 MPa), and compressive strength (266 MPa) are statistically indistinguishable for the predicate and applicant product.
BIOCOMPATIBILITY of APPLICANT DEVICE
Agarose diffusion method for cytotoxicity using L-929 mouse fibroblast cells was used to assess cytotoxicity: results were negative relative to a negative and a positive control. That is, ORTHO ONE was found to be non-toxic for L-929 mouse fibroblast cells under the described test parameters.
Jamu L. Sandise
James L. Sandrik, Ph.D Bisco, Inc. Itasca, IL 60143
July 25, 1996