(79 days)
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No
The summary describes a composite filling material and its physical properties, with no mention of AI or ML.
No
The device, a composite filling material, is used for dental restorations and repairs, which is a structural and restorative function rather than a therapeutic one designed to treat a disease or improve a health condition.
No
This device is described as a "composite filling material" used for "fillings" and "repairing facings on crowns and bridges," which are treatment procedures, not diagnostic ones.
No
The device description clearly states it is a "composite filling material," which is 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 describes the device as a composite filling material for dental restorations. This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The description confirms it's a composite filling material.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The anatomical site is teeth, which are the target of the restorative treatment, not the source of a diagnostic sample.
IVD devices are used to perform tests in vitro (outside the body) on samples taken from the body to provide diagnostic information. This device is used in vivo (within the body) for a restorative purpose.
N/A
Intended Use / Indications for Use
The modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials, and are indicated for the following uses: (1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.
Product codes
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Device Description
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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
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Key Metrics
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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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§ 872.3690 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
K962440
SEP 11 1996
II. 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submission for tooth shade resin material, tradenamed Pertac®-Hybrid® (K900510). The modified materials, referred to by the tradenames Pertac® II and Pertac® II Aplitip®, are intended as composite filling materials, and are indicated for the following uses: (1) fillings in Class I, III, IV, V and small Class II cavities; (2) fillings in deciduous teeth; (3) eroded and abraded cervical areas (wedge-shaped defects); (4) fabricating indirect anterior laminate veneers and tooth colored inlays; and (5) repairing facings on crowns and bridges.
ESPE is claiming substantial equivalence to its previously cleared Pertac®-Hybrid® product. These products have almost identical intended uses and similar ingredient compositions. To support substantial equivalence to predicate products, the physical and technical characteristics of Pertac® II/Pertac® II Aplitip® have been compared to those of Pertac®-Hybrid®. In addition, certain tests have been performed by the manufacturer, Peroxid-Chemie, on the peroxide component added to Pertac®
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1
II/Pertac® II Aplitip® to confirm safe use of the product, including skin irritation, eye irritation, Ames and acute toxicity.
Pertac® II and Pertac® II Aplitip® meet the requirements of relevant DIN and ISO standards for dental composite material.
ESPE's 510(k) has been submitted on June 19, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395) .