(57 days)
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No
The device description details a chemical bonding agent and its application process, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a bonding agent used in restorative dental procedures, not a device intended to treat or cure a disease or condition.
No
The device is a bonding agent used in dental restorative procedures, not for diagnosing conditions.
No
The device description clearly indicates it is a chemical bonding agent, a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental bonding agent used in vivo (on a living patient's tooth) for restorative procedures. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a material applied directly to the tooth surface and light-cured, which is consistent with a dental restorative product, not an IVD.
- Anatomical Site: The anatomical site is the tooth, which is part of the living body.
Therefore, PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a dental device used for treatment and restoration, not an IVD used for diagnostic purposes.
N/A
Intended Use / Indications for Use
PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish.
Product codes
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Device Description
PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a one-component, no-mix visible light curable dental bonding agent.
The new bonding agent consists of a mixture of monomers and an adhesion promoter in an acetone solution. Additionally, the mixture contains photo-initiators, accelerators and polymerization inhibitors which allow for a shelf stable material that can be polymerized using visible light energy.
Once the tooth to be restored has been prepared, PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is applied, left on the surface for 20-30 seconds, air dried, and then light cured for 10 seconds. A second application may be applied for direct restorative procedures, but this is not required for indirect procedures.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 877 ork. PA 17405-0872 171 845-7511 x (717) 854-2343
P. J. Lehn Telefax (717) 849-4343
CONTACT : P. Jeffery Lehn DATE PREPARED: February 27, 1996 TRADE OR PROPRIETARY NAME: PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT COMMON OR USUAL NAME: Bonding agent CLASSIFICATION NAME: Resin tooth bonding agent 21 CFR, 872.3200 LEGALLY MARKETED DEVICE: Prime & Bond™ Direct Composite Bonding Agent K931812 Prime & Bond - New Uses K951864
DEVICE DESCRIPTION: PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a one-component, no-mix visible light curable dental bonding agent.
The new bonding agent consists of a mixture of monomers and an adhesion promoter in an acetone solution. Additionally, the mixture contains photo-initiators, accelerators and polymerization inhibitors which allow for a shelf stable material that can be polymerized using visible light energy.
Once the tooth to be restored has been prepared, PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is applied, left on the surface for 20-30 seconds, air dried, and then light cured for 10 seconds. A second application may be applied for direct restorative procedures, but this is not required for indirect procedures.
INTENDED USE: PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish.
TECHNOLOGICAL CHARACTERISTICS: All of the components of PRIME & BOND™ 2.0 SELF-PRIMING DENTIN/ENAMEL BONDING AGENT have been used in Dentsply legally marketed predicate devices.
In K931812, Prime & Bond™ Direct Composite Bonding Agent was evaluated for cytotoxicity and for irritation and found to be non-cytotoxic and a non-irritant. Due to the similarity of the new formulation to this predicate device, we believe that additional toxicity testing for PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is unnecessary.
We believe that the prior use of the PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT components in predicate devices, the performance data presented, and the results of toxicity testing on predicate devices, support the safety and effectiveness of PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT for the intended uses.