(256 days)
Dentisply
Not Found
No
The summary describes an ultrasonic scaler with automatic tuning, which is a common feature in such devices and does not inherently indicate the use of AI or ML. There are no mentions of AI, ML, image processing, or data-driven performance metrics.
Yes.
The device is an ultrasonic scaler intended for the removal of calculus and plaque, which is a therapeutic intervention for dental hygiene and health.
No
Explanation: The device, an ultrasonic scaler, is used for the removal of calculus and plaque, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly indicates it is a hardware device (ultrasonic scaler with handpiece, control knobs, and display panel) and does not mention any software component as the primary medical device.
Based on the provided information, the DELSONIC 2000 Ultrasonic Scaler is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "removal of light to heavy calculus and plaque." This is a physical procedure performed directly on a patient's teeth, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a device that generates ultrasonic vibrations for physical removal of material. It doesn't describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document 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 diagnostic information based on sample analysis
Therefore, the DELSON0IC 2000 is a medical device used for a dental procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DELSONIC 2000 Ultrasonic Scaler is intended to be used fast and reliable removal of light to heavy calculus and plaque. This 29kHz ultrasonic system provides automatic tuning for each scaling insert.
Product codes
76ELC
Device Description
The DELSONIC 2000 is an automatically tuned piezo ultrasonic scaler that generates linear tip movement at 29kHz for efficient, yet gentle calculus removal. The DELSONIC piezo ultrasonic scaler is designed for the prevention of crossinfection with fully autoclavable handpiece sleeves sterlisible removable control knobs and wipe clean display panel
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Dentisply
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.
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GREEN RIVER INC.
5101 N.W. 21ST.AVE. SUITE 141 FORT LAUDERDALE, FL 33309 (954) 733-4300 TLX (954) 733-4303
510(K) SUMMARY
NOV - 5 1999
Applicant's Name & Street Address
Green River Inc. dba Summit Dental Systems (SDS) 5101 NW 21st Avenue , suite 141 Fort Lauderdale, Fl. 33309
Contact Person: Cesar R. Coral, President Telephone and Fax Numbers of Applicant or Contact: (954) 733-4300 (954) 733-4303
Address(es) of Manufacturing and Sterilizing Site(s):
DELDENT LTD. 19 Keren Kayemet Street Petach Tikva 49372 lsrael
Trade Name: Delsonic 2000 Ultrasonic Scaler
Common Name: Ultrasonic Scaler
Classification Name : Scaler, Ultrasonic (No.8724850, Code 76ELC, Class II)
Substantial Equivalence Comparison:
- Dentisply .
Description of Device:
The DELSONIC 2000 is an automatically tuned piezo ultrasonic scaler that generates linear tip movement at 29kHz for efficient, yet gentle calculus removal. The DELSONIC piezo ultrasonic scaler is designed for the prevention of crossinfection with fully autoclavable handpiece sleeves sterlisible removable control knobs and wipe clean display panel
Intended Use of Device:
The DELSONIC 2000 Ultrasonic Scaler is intended to be used fast and reliable removal of light to heavy calculus and plaque. This 29kHz ultrasonic system provides automatic tuning for each scaling insert.
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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a symbol that appears to be three stylized human profiles facing to the right, with flowing lines above and below them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1999
Ms. Veronica Coral Vice President Green River, Incorporated 5101 N.W. 21st Avenue, Suite 141 Fort Lauderdale, Florida 33309
K990546 Re : Ultrasonic Scaler Trade Name: Requlatory Class: II Product Code: ELC Dated: February 19, 1999 Received: February 22, 1999
Dear Ms. Coral:
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, Druq, 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 aqainst 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 - Ms. Coral
obligation you might have under sections 531 through 542 of obligation you may the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as first receir will as a market notification. The FDA described in your sio\n, promatince of your device to a legally rinding of bubboandaalicy results in a classification for your marketed predicato and the your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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 Compriance at (301) Sectising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulacion chilica, "Hibbranding by Sorber 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 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 Radiological Health
Enclosure
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K 990 54/6/14'
FDA/CDRH/ODE/DMC
APR 5 10 32 AM '99
RECEIVED
Page
510(k) NUMBER (IF KNOWN): | K 990546 |
---|---|
DEVICE NAME: | Delsonic 2000 |
INDICATIONS FOR USE: |
Ultranic Scaler is intended to be us The delsonic 2000 fast and reliable removal of light to heavy calculus and plaque. This 29KHZ ultrsonic system provides automatic tuning for eabh scaling insert.
(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 Rums
(Division Sign-Of Division of Dental, Inf and General Ho 510(k) Number
sh
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