(108 days)
Not Found
No
The summary describes a mechanical device that uses ultrasonic vibration and does not mention any AI or ML components or functionalities.
Yes
The Air Sonic Scaler is used for dental cleaning and periodontal therapy, which involves treating conditions affecting the teeth and gums. This aligns with the definition of a therapeutic device as it is used to treat or alleviate a medical condition.
No
The device is used for cleaning and therapy to remove deposits from teeth, which is an interventional or treatment purpose, not a diagnostic one.
No
The device description explicitly states it uses a surgical stainless steel tip and generates a vibrating frequency, indicating a physical hardware component is essential to its function.
Based on the provided information, the Air Sonic Scaler is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to remove calculus, tartar, and stains from teeth during dental procedures. This is a direct treatment/therapy applied to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device description details a tool that uses ultrasonic vibrations to physically remove deposits from teeth. This is a mechanical action, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The Air Sonic Scaler is a dental instrument used for cleaning and therapy, which falls under the category of medical devices used for treatment or procedural purposes, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Air Sonic Scaler, is intended for use by medical professionals during cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a surgical 440A stainless steel tip, The tip comes in 3 different shapes (AS1, AS2, AS3) and is designed to generate a vibrating frequency of 6,000 Hz.
The intended use of the Air Schic Scaler is intended for use by dental professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits from teeth.
Product codes
ELC
Device Description
The Air Sonic Scaler, is intended for use by medical professionals during cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a surgical 440A stainless steel tip, The tip comes in 3 different shapes (AS1, AS2, AS3) and is designed to generate a vibrating frequency of 6,000 Hz.
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
medical professionals, 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)
Lynx-SM. Scaler Dental Handpiece, K901488
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 3 0 2009
Image /page/0/Picture/1 description: The image shows the logo for DPM USA Dental Products Manufacture. The logo features the letters "DPM" in large, bold font, with a star on top of the "D" and "P". The words "USA Dental Products Manufacture" are written in a smaller font to the right of the letters. The word "CORP." is written on the bottom left of the logo.
October 9. 2008
Section III - 510(k)
Summary of Safety and Effectiveness
Submitter:
DPM USA Corp. 1460 NW 107 Ave Suite G Miami, Florida 33172 Phone: 305-640-9894 Fax: 305-477-3206 Contact Person: George Echeverri
Summary Prepared Date: October 9, 2008
Device Name:
-
- Trade Name- Air Sonic Scaler
- II. Common Name- Air-Powered Ultrasonic Scaler
- III. Classification Name- Ultrasonic Scaler
- IV. Classification Number: 21 CFR 872.4850
- V. Product Code: ELC
Device for Which Substantial Equivalence is Claims:
-
- Lynx-SM. Scaler Dental Handpiece
-
- 510 (k) K901488
-
- Manufacture: MTI Precision Products, Inc.
Device Description / Intended Use:
The Air Sonic Scaler, is intended for use by medical professionals during cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a surgical 440A stainless steel tip, The tip comes in 3 different shapes (AS1, AS2, AS3) and is designed to generate a vibrating frequency of 6,000 Hz.
FDA CDRH DMC
JAN 2 7 2009
Received
K-37
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3.0 2009
Mr. George Echeverri Director DPM USA Corporation 1460 NW 107 Avenue, Suite G Miami, Florida 33172
Re: K083059
Trade/Device Name: Air Sonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 9, 2008 Received: January 27, 2009
Dear Mr. Echeverri:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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 . (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Echeverri
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours,
Anthony D. Watson for
Ginette Y. Michaud, M.D.
Acting Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if know):
Device Name: Air Sonic Scaler
Indications for Use:
The intended use of the Air Schic Scaler is intended for use by dental professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits from teeth.
Prescription Use × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number.__