(195 days)
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No
The description details a mechanical device for measuring pocket depth and manually recording observations, with no mention of automated analysis, learning algorithms, or AI/ML terms.
No.
The device is used for screening and tracking disease progression, measuring gingival pocket depth, and registering bleeding or plaque, which are diagnostic and monitoring functions, not therapeutic.
Yes
The device is described as being used to "screen patients and to track disease progression in the target population of patients who are suspected of having or already have periodontal disease," which clearly indicates a diagnostic purpose. It measures gingival pocket depth, bleeding on probing, and plaque presence, all of which are diagnostic indicators for periodontal disease.
No
The device description explicitly mentions a "handpiece" and an "electronics unit," indicating physical hardware components are part of the device.
Based on the provided information, the Perio Control II™ is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Perio Control II™ Function: The Perio Control II™ directly measures the physical depth of the gingival pocket within the patient's mouth. It also allows for the visual registration of bleeding and plaque. These are direct physical measurements and observations made in vivo (within the living body), not tests performed on in vitro (outside the living body) specimens.
The device is a diagnostic tool used in a clinical setting to assess the physical state of the gingiva, but it does not involve the analysis of biological samples.
N/A
Intended Use / Indications for Use
The intended use of the "Perio Control II™" device is to screen patients and to track disease progression in the target population of patients who are suspected of having or already have periodontal disease. Both pediatric and adult patients may be tested.
The Perio Control II is used during periodontal examination to measure gingival pocket depth. The pocket depth is displayed on the electronics unit and can be entered in an external computer system, either a PC or a Psion Series 3C.
Also, the eventual occurrence of bleeding on probing can be registered, as well as the presence of supra-gingival plaque. This is judged visually and registered by pressing one of the buttons on the "Perio Control IITM" handpiece.
The pocket depth is measured by entering the probe tip into the gingival pocket and forcing the filament of the probe up into the sleeve is at a specific reference point. In this position one of the buttons on the "Perio Control IITM" handpiece is pressed. The pocket depth is now displayed on the electronics unit.
Product codes (comma separated list FDA assigned to the subject device)
EIX
Device Description
The Perio Control II™ is used during periodontal examination to measure gingival pocket depth. The pocket depth is displayed on the electronics unit and can be entered in an external computer system, either a PC or a Psion Series 3C)
Also, the eventual occurrence of bleeding on probing can be registered, as well as the presence of supra-gingival plaque. This is judged visually and registered by pressing one of the buttons on the Perio Control IITM handpiece.
The pocket depth is measured by entering the probe tip into the gingival pocket and forcing the filament of the probe up into the sleeve until the sleeve is at a specific reference point. In this position one of the buttons on the Perio Control II handpiece is pressed. The pocket depth is now displayed on the electronics unit.
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
gingival pocket
Indicated Patient Age Range
Both pediatric and adult patients may be tested.
Intended User / Care Setting
Not Found
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)
The results of bench and user testing indicates that the new device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measuring range: 0-10.5mm
Probe tip shape: spherical
Probe tip dimension: 0.5mm
Probe tip material: Stainless steel
Sterilization: Same (as predicate)
Accuracy: 0.2mm
Probing force: 0.17-0.32 N
Probing pressure: 100-200 N/cm2
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).
Not Found
§ 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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| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972642 |
| Prescription Use
| (Per 21 CFR 801.109) | OR Over the Counter Use ______ |
|---|---|
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