(256 days)
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.
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
The provided text is a 510(k) summary for the Delsonic 2000 Ultrasonic Scaler. It does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.
The document is a submission to the FDA for market clearance, stating the device's substantial equivalence to a predicate device (Dentsply). It describes the device, its intended use, and its classification. The subsequent pages are the FDA's response letter granting market clearance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The requested information is not present in this document.
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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
1
§ 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.