(230 days)
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Not Found
No
The summary describes a standard electric ultrasonic scaler and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML device submissions.
Yes
The device is described as an "electric ultrasonic scaler" and its intended uses include "Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative," which are all therapeutic procedures.
No
Explanation: The device is an electric ultrasonic scaler used for various dental procedures like scaling, perio, and implant maintenance. These are therapeutic and maintenance procedures, not diagnostic ones. There is no indication that it identifies or diagnoses any condition.
No
The device is described as an "electric ultrasonic scaler," which is a hardware device. The summary does not mention any software component that functions as a medical device on its own.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (Scaling, Perio, Implant Maintenance, Endodontic, etc.) are all procedures performed directly on a patient's teeth and surrounding tissues. IVDs are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Description: An electric ultrasonic scaler is a tool used for physical procedures in the mouth, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
Therefore, the Varios 560 electric ultrasonic scaler is a medical device used for dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device, Varios 560, an electric ultrasonic scaler, is intended for use with an appropriate tip for following use. - Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for Minimal Scameg, Forto, Inprintin Mailier, Balishing / Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
Product codes
ELC
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
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Indicated Patient Age Range
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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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§ 872.4850 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Norimasa Kaneko NAKANISHI, Incorporated 700 Shimohina Kanuma-Shi, Tochigi-Ken JAPAN 322-8666
MAY - 1 2007
Re: K062731
Trade/Device Name: Ultrasonic Scaler Various 560 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: April 20, 2007 Received: April 24, 2007
Dear Mr. Kaneko:
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.
1
Page 2 - Mr. Kaneko
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use Statement
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Varios 560 |
Indications For Use:
This device, Varios 560, an electric ultrasonic scaler, is intended for use with an appropriate tip for following use.
- Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for Minimal Scameg, Forto, Inprintin Mailier, Balishing / Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
(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 801.109)
Susan Rusme
in of Anesthesiology, General Hospital Juon Control. Dental Devices
C(k) Number :_
OR
4 - 1
Over-The-Counter Use _