(189 days)
KAVO AMERICA'S SONICFLEX
KAVO AMERICA'S SONICFLEX
No
The summary describes a mechanical dental scaler and does not mention any AI/ML components or capabilities.
Yes
The device is used for dental treatment to remove calculus and plaque, which addresses a health condition (dental plaque and calculus buildup) and aims to restore dental health. The description also highlights pain reduction and post-operative refreshment, suggesting a direct therapeutic effect.
No
The device is described as an instrument for calculus and plaque removal, primarily for dental treatment. Its function is debriding deposits, not diagnosing conditions.
No
The device description clearly states it is an "air scaler" and describes physical components and their function in calculus and plaque removal, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- VIP 60 Function: The VIP 60 is an instrument used directly on the patient's teeth and root surfaces for calculus and plaque removal. It is a therapeutic and procedural device, not a diagnostic one that analyzes samples.
The description clearly indicates its use in a dental treatment setting for a physical procedure on the patient.
N/A
Intended Use / Indications for Use
The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding to heavy calculus and plaque deposits from tooth and root surfaces.
Product codes
ELC
Device Description
The general componets, design, characteristics, and mode of operation of the VIP60 and accessories are substantially Equivalent to Kavo America's SONICFLEX. SONICflexLUX offers fiber optic illumination for maximum visibility in the scaling area. SONIX flexLUX permits the removal of calculcus and tartar by mechanical vibration. Coolant water actually runs through and exits at the tip -- where you need it. Designed for repeated sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth and root surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist / dental treatment
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)
KAVO AMERICA'S SONICFLEX
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
OCT 1 8 1999
510 (k) Summary
Applicant:
MICRON CORPORATION 1-34-14 Higashiyukigaya Ohta-ku, Tokyo 145-0065 JAPAN Tel: 81 3 3726 0396 Fax: 81 3 3726 5396
Contact Person: Eiji Suzuki
Date Summary Prepared:
April 06, 1999
Classification Name:
Scaler Ultrasonic 21 CFR, 872.4850
Common Name:
Air scaler
Trade Name:
VIP 60
Predicate Devices:
KAVO AMERICA'S SONICFLEX
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Intended Use
The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment.
This VIP 60 is used with scaling tips and a coolant water spray for debriding to heavy calculus and plaque deposits from tooth and root surfaces.
Discription of Device
Adavantages for patients
1.Much less pain as compared with ultrasonic scaling.
- 2.Less oppressive pain and less irritation to the tooth and gingiva.
- 3.Mush less bleeding
- 4.Post operative refreshness from pocket irrigation.
Adavantages for operators
1.Direct connection to handpiece hose is possible.
- 2.Water spraying is minimum and working sites is clearly visible.
- 3.As the scaler tip is much more delicate (thin), subgingival pockets, interdental areas and molar furcations could be reached.
- 4.For the same reason, the feel of calculus adherence on the tooth can be transmitted to the operater's fingers, enabling careful and complete scaling even under indirect visualization.
- 5.Similarly, because delicate manipulation is possible, operator can avoid direct touching of hypersensitive areas of the tooth.
Note
In using an ultrasonic scaler, it is indicated that the tip is favorably, kept at approximately 15 degrees during scaling in order to prevent injuring of the enamel.
In the case of VIP60 (air scaler), the tip can approach the tooth surface in point contact which is more effective.
Technological Characteristics and Substantial Equivalence
The general componets, design, characteristics, and mode of operation of the VIP60 and accessories are substantially Equivalent to Kavo America's SONICFLEX. SONICflexLUX offers fiber optic illumination for maximum visibility in the scaling area. SONIX flexLUX permits the removal of calculcus and tartar by mechanical vibration. Coolant water actually runs through and exits at the tip -- where you need it. Designed for repeated sterilization.
2
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 image of three abstract human figures, possibly representing health, family, and community.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 1999
Mr. Eiji Suzuki Micron Corporation 1-34-14, Higashiyukigaya, Ohta-Ku Tokyo 145, Japan
Re : K991239 VIP 60 (2H) Model 115-000-1 & VIP 60 (4H) Trade Name: Model 115-000-2 Regulatory Class: II Product Code: ELC July 20, 1999 Dated: Received: July 20, 1999
Dear Mr. Suzuki:
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 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 (Premarket Approval), 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 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 not affect any
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Page 2 - Mr. Suzuki
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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.fda/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 Radioloqical Health
Enclosure
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Page 1_of_1
510(k) Number (if known): K991239
Device Name: VIP 60 Model 115-000-1 and Model 115-000-2 (Sonic Scaler)
Indications For Use:
The VIP 60 is an instrument of calculus and plaque removal which the dentist uses for dental treatment. This VIP 60 is used with scaling tips and a coolant water spray for debriding heavy calculus and plaque deposits from tooth and root surfaces.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Rinnols
(Division Sign-Off) Division of Dental, Int and General Hoss 510(k) Number