(126 days)
Not Found
No
The description focuses on the mechanical and physical principles of ultrasonic vibration for dental cleaning and does not mention any AI or ML components.
No
The device is used for dental cleaning and plaque removal, which is a prophylactic and maintenance procedure, not a therapeutic treatment for a disease or condition.
No
The device's intended use is for dental cleaning and removal of calculus and plaque using ultrasonic vibration, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical ultrasonic insert with metal tips and a water supply, designed to be used within a hardware handpiece. There is no mention of software as the primary or sole component.
Based on the provided information, this device 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 Insight Ultrasonic Insert is a dental instrument used for physical removal of calculus and plaque from teeth using ultrasonic vibrations. It operates directly on the patient's teeth, not on a sample taken from the body.
- Intended Use: The intended use clearly states it's for "dental cleaning and removal of tenacious calculus and plaque." This is a physical procedure, not a diagnostic test.
Therefore, the device falls under the category of a dental instrument or device used for treatment/procedure, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.
Product codes
ELC
Device Description
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used to remove tenacious calculus and plaque by ultrasonic vibrations. When place inside the handpiece, the ultrasonic insert is exposed to a varying magnetic field created by a unique pattern of copper wiring wrapping the plug of the handpiece. The varying magnetic field causes the insert "stack" of the metal tips to contract and expand, thus resulting in insert tip vibration in an elliptical motion. The water supply in the insert washes away the debris and cools the insert tip. The distal 4.3 mm portion of the insert tip is affected by the frequency of 25,000 to 30,000 Hz and The tips are offered in two frequencies, six performs the instrumentation. different colors and twenty different tip styles.
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
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.)
Not Found
Predicate Device(s)
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
KO92412
DEC 1 1 2009
B. Summary of Safetv and Effectiveness
Insight Ultrasonic Inserts
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- Date of Summary Preparation:
July 23, 2009
- Date of Summary Preparation:
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- Submitting Firm:
Discus Dental, LLC.
- Submitting Firm:
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Contact Person
Winkie Wong Associate, Regulatory Affairs Discus Dental, LLC. 8550 Higuera Street Culver City, CA 90232 310.845.8339 310.845.8647 - fax
Name of Medical Device Proprietary Name:
Insight Ultrasonic Inserts
Common/Usual Name: Ultrasonic Inserts
Classification Name:
Scaler, Ultrasonic
న. Description of Medical Device
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used to remove tenacious calculus and plaque by ultrasonic vibrations. When place inside the handpiece, the ultrasonic insert is exposed to a varying magnetic field created by a unique pattern of copper wiring wrapping the plug of the handpiece. The varying magnetic field causes the insert "stack" of the metal tips to contract and expand, thus resulting in insert tip vibration in an elliptical motion. The water supply in the insert washes away the debris and cools the insert tip. The distal 4.3 mm portion of the insert tip is affected by the frequency of 25,000 to 30,000 Hz and The tips are offered in two frequencies, six performs the instrumentation. different colors and twenty different tip styles.
Intended Use 6.
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.
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Substantial Equivalence Determination 7.
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Discus Dental, LLC. believes that the Insight Ultrasonic Inserts are substantially equivalent to the following commercially marketed ultrasonic inserts:
| Predicate Device | Company | 510(k) No. |
|---|---|---|
| Protégé Ultrasonic Inserts | Discus Dental | K051776 |
| Ultrasonic Scaler Inserts | Hu-Friedy MFG. CO., Inc. | K953919 |
| Satin Swivel Ultrasonic Inserts | Hu-Friedy MFG. CO., Inc. | K012060 |
END OF SUMMARY OF SAFETY AND EFFECTIVENESS
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Discus Dental, LLC.
B-2
CONFIDENTIAL
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a symbol often associated with healthcare, but in this case, it is a modern interpretation of the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Winkie Wong Regulatory Affairs Associate Regulatory Affairs Discus Dental, LLC 8550 Higuera Street Culver City, California 90232
DEC 1 1 2009
Re: K092417
Trade/Device Name: Insight Ultrasonic Inserts Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: . December 8, 2009 Received: December 10, 2009
Dear Mr. Wong:
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 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.
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Page 2- Mr. Wong
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html fart the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runnes
2 Anthony D. Watson, BS, MS, MBA Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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E. Indications for Use Statement
510(k) Number: K092417
Device Name: Insight Ultrasonic Inserts
Intended Use
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use - X Per 21 CFR Sections 801.109)
OR Over-The-Counter Use
Susan Runyon
(Division Sign-Of) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: _
Discus Dental, LLC.
E - 1