(29 days)
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No
The device description and intended use are purely chemical and mechanical, with no mention of AI/ML terms or functionalities.
Yes
The device is used to control sensitivity in teeth, indicating a therapeutic purpose (treatment of a condition).
No
The device is described as a dental desensitizer used to control sensitivity and can be used under various dental restorations or to treat sensitivity. Its mechanism involves bonding with proteins to produce a physiologic barrier, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "mixture of hydroxyethylmethacrylate and glutaraldehyde in water," which is a chemical 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 is to control sensitivity in teeth during dental procedures and to treat existing sensitivity. This is a direct treatment applied to the patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a chemical mixture applied to the tooth structure to create a barrier. This is a therapeutic action, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like blood, urine, or tissue), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pulpdent DESENSITIZER is a dental desensitizer used to control postoperative and microleakage sensitivity in teeth undergoing treatment or restoration. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity.
Product codes
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Device Description
Pulpdent DESENSITIZER is a mixture of hydroxyethylmethacrylate and glutaraldehyde in water, which can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. Pulvdent DESENSITIZER controls dentinal fluid flow by bonding with the proteins in the tubules and thereby producing a physiologic barrier.
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
teeth
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)
American Dental Products Wetting Agent and Desensitizer, Health-Dent Hema-Glu, Miles Inc. Gluma
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
X963652
OCT 11 1996
EXHIBIT 7
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown. MA 02272-0780 USA.
TELEPHONE: (617) 926-6666 FAX: (617) 926-6262 .
PULPDENT Desensitizer DEVICE NAME:
PREDICATE DEVICES: American Dental Products Wetting Agent and Desensitizer Health-Dent Hema-Glu Miles Inc. Gluma
DESCRIPTION AND INTENDED USE: Pulpdent DESENSITIZER is a dental desensitizer used to control postoperative and microleakage sensitivity in teeth undergoing treatment or restoration. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity. Pulpdent DESENSITIZER is a mixture of hydroxyethylmethacrylate and glutaraldehyde in water, which can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. Pulvdent DESENSITIZER controls dentinal fluid flow by bonding with the proteins in the tubules and thereby producing a physiologic barrier.
COMPARISON WITH PREDICATE PRODUCTS: Pulpdent DESENSITIZER is substantially equivalent in composition and intended use as the products. Please see Exhibit 5 for the entire comparison.
SAFETY AND EFFECTIVENESS: According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio... composites ... are relatively trouble free. There is no evidence of short or long term risk ... there is no suspicion of any problems after literally billions of procedures in the United States." Please see Exhibit 6 for the complete journal articles.