(155 days)
Dentsply's Cavitron® Ultrasonic 3000, 1010 and 660 Scalers, Johnson & Iohnson's Alfa-Sonic Hygienic Scaler Model 300 and Healthco's Air Flow II Scaler
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No
The summary describes a standard ultrasonic scaler with no mention of AI/ML features or related performance studies.
Yes
The device is described as an ultrasonic scaler used during dental and periodontal therapy treatments to remove calculus deposits, indicating its use in treating a condition.
No
The device is described as an ultrasonic scaler used to remove calculus deposits from teeth, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is an "ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth." This describes a physical device with a vibrating tip, not a software-only device.
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 calculus deposits from teeth during dental and periodontal therapy. This is a direct treatment applied to the patient's body (teeth).
- Device Description: The description confirms it's an ultrasonic scaler that applies a vibrating tip to the teeth. This is a physical intervention on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is purely therapeutic/procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
"an ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"The device for which 510(k) recognition of substantial equivalence is sought is an ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth."
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.)
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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.
Dentsply's Cavitron® Ultrasonic 3000, 1010 and 660 Scalers, Johnson & Iohnson's Alfa-Sonic Hygienic Scaler Model 300 and Healthco's Air Flow II Scaler
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
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
C. EXECUTIVE SUMMARY
APR 22 1997
1. Reason for Submission
Premarket notification, as required under Section 510(k) of the Federal Food, Drug, and Cosmetic (FD&C) Act, facilitates the marketing of medical devices that are "new" to a company but substantially equivalent to devices that are already legally marketed. This submission provides the premarket notification required by section 510(k) of the Act and 21 CFR $807.87
2. Description
The device for which 510(k) recognition of substantial equivalence is sought is an ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
3. Substantial Equivalence
Comparison in terms of "substantial equivalence" is made to other marketed devices. Professional Dental Manufacturing, Inc.'s device is substantially equivalent to predicate devices because it has the same intended use as a host of ultrasonic scalers, in particular, Dentsply's Cavitron® Ultrasonic 3000, 1010 and 660 Scalers, Johnson & Iohnson's Alfa-Sonic Hygienic Scaler Model 300 and Healthco's Air Flow II Scaler. For purposes of this PMN, we will compare the Pro-Select3TM to the Cavitron® Model 3000.
This PMN establishes that the Pro-Select;3™ is substantially equivalent to the predicate device in its respective ability to remove calculus deposits from the teeth. Furthermore, this PMN establishes that Pro-Select3™s technological characteristics are similar enough to the Cavitron® devices that it will not affect safety and effectiveness.