(79 days)
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No
The summary does not mention any AI or ML terms, image processing, or describe any training or test sets, which are typical indicators of AI/ML use in medical devices. The device description is purely mechanical.
No
This device is an automated periodontal probe, used for diagnostic measurements (measuring depth of gingival sulcus) and charting, not for treatment or therapy.
Yes
The device is described as an "automated periodontal probe intended for use during periodontal examinations to measure and chart the depth of a gingival sulcus in millimeters". Measuring and charting the depth of a gingival sulcus for examination purposes is a diagnostic function.
No
The device description explicitly states it consists of a control unit, a transducer, and disposable handpieces, which are all hardware components.
Based on the provided information, the Pro-Dentec's VICTOR Interactive Probe is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The VICTOR Interactive Probe directly measures the depth of a gingival sulcus in vivo (within the living body) using a physical probe. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure and chart the depth of a gingival sulcus, which is a physical measurement, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of a medical device used for examination and measurement, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pro-Dentec's VICTOR Interactive Probe is an automated periodontal probe intended for use during periodontal examinations to measure and chart the depth of a gingival sulcus in millimeters.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The device is a periodontal probe which is used by dental professionals during periodontal examinations. The device consists of a control unit, a transducer connected by a cable to the control unit and single use, disposable handpieces.
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
dental professionals
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)
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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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§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1. Name and Address
This Summary of Safety and Effectiveness is being submitted by Pro-Dentec, Inc., P.O. Box 4129, Batesville, Arkansas 72503. The telephone number is 501-793-2300.
2. Name of the Device
The device is generally known as an Electronic Periodontal Probe.
3. Identification of Predicate Device(s)
Florida Probe Corporation's "Florida Probe," K875076, and the manual Michigan periodontol probes.
4. Description of the Device
The device is a periodontal probe which is used by dental professionals during periodontal examinations. The device consists of a control unit, a transducer connected by a cable to the control unit and single use, disposable handpieces.
5. Intended Use of the Device
Pro-Dentec's VICTOR Interactive Probe is an automated periodontal probe intended for use during periodontal examinations to measure and chart the depth of a gingival sulcus in millimeters.
6. Comparison of Technological Characteristics
The differences between Pro-Dentec's VICTOR Interactive Probe and the predicate device are minor and do not impact the safety and effectiveness of the device in any significant way.