(66 days)
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No
The summary describes a dental cement material and its physical properties, with no mention of AI or ML technologies.
No
The device is a glass ionomer cement material used for dental fillings and core build-ups, which are restorative rather than therapeutic actions.
No
Explanation: The device is a dental cement material used for fillings and core build-ups, not for diagnosing a condition or disease.
No
The device description clearly states it is a "slightly modified glass ionomer cement 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 uses listed are all related to dental procedures performed directly on a patient's teeth (fillings, linings, core build-ups). IVDs are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The device is described as a "glass ionomer cement material," which is a substance used in dental restorations, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, Ketac-Molar® Aplicap® is a dental material used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: (1) linings for Class I and II cavities filled with composite; (2) core build-ups; (3) fillings in deciduous teeth; (4) fillings in Class I cavities located in non-occlusal load bearing areas; (5) fillings in Class V cavities if the aesthetics are not of primary importance; and (6) temporary fillings in Class I and II cavities.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Ketac-Molar® Aplicap® is a glass ionomer cement material, created by modifications to Ketac-Bond® Aplicap® and Ketac-Silver® Aplicap, to provide for an improved compressive strength.
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)
To support substantial equivalence to predicate products, the physical and technical characteristics, as well as the water soluble fluoride content, of Ketac-Molar® Aplicap® have been compared to those of Ketac-Bond® Aplicap® and Ketac-Silver® Aplicap®. Ketac-Molar® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement.
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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§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
510 (X) SUMMERY OF SAFITY AND EXERCLY FRIEND II.
ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submissions for dental cement material, tradenamed Ketac-Bond® Aplicap® (K874788) and Ketac-Silver® Aplicap (K843566), to create slightly modified glass ionomer cement material, referred to by the tradename Ketac-Molar Aplicap®. The reason for this modification is to provide for an improved compressive strength. Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: (1) linings for Class I and II cavities filled with composite; (2) core build-ups; (3) fillings in deciduous teeth; (4) fillings in Class I cavities located in non-occlusal load bearing areas; (5) fillings in Class V cavities if the aesthetics are not of primary importance; and (6) temporary fillings in Class I and II cavities.
ESPE is claiming substantial equivalence to its previously cleared Ketac-Bond® Aplicap® and Ketac-Silver® Aplicap® products. These products have similar intended uses and, in the case of Ketac-Bond® Aplicap®, the same principal ingredient composition.
To support substantial equivalence to predicate products, the physical and technical characteristics, as well as the water soluble fluoride content, of Ketac-Molar® Aplicap® have been compared to those of Ketac-Bond® Aplicap® and Ketac-Silver®
WA01A/A31059.1
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1
Aplicap®. Ketac-Molar® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement.
ESPE's 510(k) has been submitted on March 6, 1996, by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).
WA01A/A31069.1
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