(79 days)
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No
The device is a dental filling material and bonding agent, with no mention of software, algorithms, or data processing that would suggest AI/ML.
No.
The device is a dental filling material and bonding agent, which are used to restore teeth, not to treat a disease or condition in a therapeutic sense.
No
The device is described as a compomer filling material and a light-cured bonding agent, intended for filling teeth. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the device is a "compomer filling material" and a "light cured bonding agent," which are physical substances, 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 the device as a dental filling material and bonding agent used for treating cavities and other dental issues. This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The description confirms it's a filling material and bonding agent.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) to diagnose a condition, monitor treatment, or screen for diseases.
- Performance Studies: The performance studies focus on physical and technical characteristics, toxicity, and sensitization, which are relevant to the safety and efficacy of a dental material used in the mouth, not for in vitro diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health status. This device does not fit that description.
N/A
Intended Use / Indications for Use
Hytac® Aplitip® is a compomer filling material indicated for the following uses: (1) fillings in deciduous teeth; (2) fillings in Class V cavities; (3) eroded and abraded cervical areas; (4) fillings in Class III cavities; and (5) temporary fillings in Class I and II cavities. Hytac® OSB is a light cured bonding agent for use with compomer filling materials.
Product codes
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Device Description
Hytac® Aplitip® and Hytac® OSB are dental materials. Hytac® Aplitip® is a compomer filling material, and Hytac® OSB is a light cured bonding agent for use with compomer filling materials.
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)
Physical and technical characteristics, as well as water soluble fluoride content, of Hytac® Aplitip® were compared to Pertac®-Hybrid® and Ivoclar's Compoglass®. Tests performed on final Hytac® product included cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity and sensitization, with results indicating no adverse toxicity.
Physical and technical characteristics of Hytac® OSB were compared to Pertac® Universal Bond and Ivoclar's Compoglass® SCA. A sensitization test on the final Hytac® OSB product showed no sensitization.
Both products meet requirements of relevant DIN and ISO standards for dental composite material.
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
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submissions for tooth shade resin material, tradenamed Pertac®-Hybrid® (K900510), and the corresponding bonding agent, tradenamed Pertac® Universal Bond (K904289). The modified materials, referred to by the tradenames Hytac® Aplitip® and Hytac® OSB, respectively, are intended as compomer filling material and corresponding bonding agent. Hytac® Aplitip® is a compomer filling material indicated for the following uses: (1) fillings in deciduous teeth; (2) fillings in Class V cavities; (3) eroded and abraded cervical areas; (4) fillings in Class III cavities; and (5) temporary fillings in Class I and II cavities. Hytac® OSB is a light cured bonding agent for use with compomer filling materials.
With respect to Hytac® Aplitip®, ESPE is claiming substantial equivalence to its previously cleared Pertac®-Hybrid® product and Ivoclar's Compoglass® (K951836). These products have similar intended uses and, in the case of Compoglass®, the same principal ingredient composition. To support substantial equivalence to predicate products, the physical and technical
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characteristics, as well as the water soluble fluoride content, of Hytac® Aplitip® have been compared to those of Pertac®-Hybrid® and Ivoclar's Compoglass®. In addition, certain tests have been undertaken on the final Hytac® product, including cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity and sensitization. Results of these studies indicate that the final product shows no adverse toxicity results.
With respect to Hytac® OSB, ESPE is claiming substantial equivalence to its previously cleared Pertac® Universal Bond and to Ivoclar's Compoglass® SCA (K951836). All products have the same intended use and all but one of the same components. To support substantial equivalence to predicate products, the physical and technical characteristics of Hytac® OSB have been compared to those of Pertac® Universal Bond and Ivoclar's Compoglass® SCA. In addition, the sensitization test has been performed on the final Hytac® OSB product to confirm safe use of the product, and test results show no sensitization.
Hytac® Aplitip® and Hytac® OSB meet the requirements of relevant DIN and ISO standards for dental composite material.
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ESPE's 510(k) has been submitted on June 17, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).