(285 days)
Not Found
No
The device is a prophy paste, a physical substance used for cleaning teeth, and the summary contains no mention of AI or ML.
No.
The primary purpose of the device is to remove stains and plaque, which is a cosmetic and cleaning procedure rather than treating or preventing a disease or condition. While maintaining oral hygiene is important for health, this specific function of stain removal does not inherently classify it as a therapeutic device.
No
The device is a prophy paste used for cleaning teeth, not for diagnosing medical conditions.
No
The device description clearly states it is a "prophy paste," which is a physical substance used in dentistry, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove materia alba, plaque, and stains from teeth. This is a physical cleaning action performed on the surface of the teeth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a prophy paste used for cleaning teeth. This aligns with the intended use and does not suggest any diagnostic function.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Anatomical Site: The anatomical site is "teeth," which are external structures. IVDs typically involve analysis of internal biological samples or processes.
In summary, the device's function is purely mechanical cleaning of the tooth surface, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The device is a prophy paste which is used by dental professionals to help remove resistant stains from the surface of the teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
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 the limitations in § 872.9.
0
I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1. Name and Address
This Summary of Safety and Effectiveness is being submitted by Challenge Products, Inc., Lake Road 54-22 P.O. Box 468, Osage Beach, Missouri 65065.
2. Name of the Device
The device is generally known as a prophy paste.
3. Identification of Predicate Device(s)
Challenge Products, Inc. Prophy Paste, FDA control number K940496.
4. Description of the Device
The device is a prophy paste which is used by dental professionals to help remove resistant stains from the surface of the teeth.
5. Intended Use of the Device
The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.
6. Comparison of Technological Characteristics
The differences between Challenge's new prophy paste and the predicate device are minor and do not impact the safety and effectiveness of the device in any significant way.
7. Safety
Challenge reviewed the 11 MDR records filed with CDRH relating to FDA's product code,"EJR" which were obtained from a CD-ROM database1. Most of the events occurred as a result from an allergic or adverse reaction to a prophy
1 The Medical Device Library, IHS Regulatory Products, 15 Inverness Way East, Englewood, CO 80150.
1
jet powder. 3 of the 11 reports were filed for a prophy paste and 1 report was on a patient with a history of allergies. These reports follow.
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