K Number
K973876
Device Name
PROPHYFLEX 2, MODEL 2012
Manufacturer
Date Cleared
1997-12-19

(70 days)

Product Code
Regulation Number
872.4200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PROPHYflex 2 dental device is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The product should not be used on patients on a saltless diet, with a renal deficiency, with a chronic respiratory disease, or with chronic diarrhea.
Device Description
Not Found
More Information

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Not Found

No
The summary describes a mechanical dental device for cleaning teeth and does not mention any AI or ML components or functionalities.

No
The device is used for cleaning teeth by removing plaque and stains, which is preventative maintenance rather than treating an existing condition or disease. The contraindications listed are due to the use of sodium bicarbonate, not because the device itself has therapeutic effects on those conditions.

No
The device is described as removing plaque and stains, indicating a treatment or cleaning function, not a diagnostic one.

No

The device description clearly indicates a physical dental device that projects a mixture of water, air, and sodium bicarbonate, which is a hardware component.

Based on the provided information, the PROPHYflex 2 dental device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to remove plaque and stains from teeth by projecting a mixture onto the tooth surfaces. This is a physical cleaning process performed directly on the patient's body (in vivo).
  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The term "in vitro" literally means "in glass" or "in the lab," referring to tests done outside the living organism.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health status based on laboratory analysis.

Therefore, the PROPHYflex 2 is a dental device used for a therapeutic/cleaning procedure performed directly on the patient, not an IVD.

N/A

Intended Use / Indications for Use

The PROPHYflex 2 dental device is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The product should not be used on patients on a saltless diet, with a renal deficiency, with a chronic respiratory disease, or with chronic diarrhea.

Product codes

EFB

Device Description

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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

Not Found

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 (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.

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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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§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.

0

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and three human profiles are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

..

Mr. Gregory W. Bowman Kavo America C/O Baker & McKenzie One Prudential Plaza 130 East Randolph Chicago, Illinois 60601

DEC 19 1997

K973876 Re : Trade Name: Prophyflex 2, Model 2012 Requlatory Class: I Product Code: EFB Dated: October 9, 1997 Received: October 10, 1997

Dear Mr. Bowman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

1

Page 2 - Mr. Bowman

not affect any obligation you might have under sections 531 noc arress any obligation devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.pda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

STATEMENT OF INDICATIONS FOR USE

510(k) Number:

Device Name: KaVo America PROPHYflex 2

Indications for Use:

The PROPHYflex 2 dental device is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The product should not be used on patients on a saltless diet, with a renal deficiency, with a chronic respiratory disease, or with chronic diarrhea.

Concurrence of CDRH, Office of Device Evaluation ("ODE")

Savad Ruan

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division of B Hospital Devices KA 72 STU 510(k) Number --

Prescription Usel (Per 21 C.F.R. § 801.109)

OR

Over-the-Counter Use