(170 days)
This unit combines both ultrasonic scaling and airpolishing functions in one compact unit that answers all prophylaxis needs. The air polishing function is intended to be used to remove stubbern stains, plaque and soft debris. The scaler funtions is intended to be used for cauculus removal. Device applications: Routine oral prophylaxis, routine polishing especially in hard to reach fissures and interproximal areas, prior to enamel etching and bonding techiniques and prior to bonding orthodontic bands and brackets.
Jetsonic 2000 combines both ultrasonic scalling and air polishing functions in one compact unt that answers all prophylaxis needs.
I am sorry, but the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for a medical device (Jetsonic 2000 Ultrasonic Scaler and Air Polishing Unit). It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device. However, it does not include details about device performance metrics, clinical studies, sample sizes, expert involvement, or ground truth establishment.
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MAY-12-99 WED 04:28 PM 11 439
GREEN RIVER INC.
ORTEDS AND EXPORTERS
- 13
101 N.W. 219T. AVE, SUITE 141 FORT LAUDEROALE, FL 33309 (954) 733-4300 TLX. 332311 GRILOG FAX: (954) 733-4303
510(K) SUMMARY
Applicant's Name & Street Address
Green River Inc. dba Summit Dental Systems (SDS) 5101 NW 21st Avenue , suite 141 Fort Lauderdale, FI. 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: Jetsonic 2000 Ultrasonic Scaler and Air Polishing Unit
Common Name: Ultrasonic Scaler/Air Polisher
Classification Name : Scaler, Ultrasonic (Code 76ELC, Class II) Jet Polisher Code 76KOJ. Class III
Substantial Equivalence Comparison:
- Dentsply .
Description of Device:
Jetsonic 2000 combines both ultrasonic scalling and air polishing functions in one compact unt that answers all prophylaxis needs.
Intended Use of Device:
The Jetsonic 2000 combination unlt (ultrasonic scaler and air polisher) provides answers to all prophylaxis needs. The air polishing function is intended to be used to remove stubborn stains, plaque and soft debris. The scaler functions is intended to be used for cauculus removal.
Device applications: routine oral prophylaxis, routine polishing, especially in hard to reach fissures and interproximal areas, prior to enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
'
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 11 1999
Mr. Cesar R. Coral President Green River, Incorporated 5101 N.W. 21st, Avenue Suite 141 Fort Lauderdale, Florida 33309
Re : K990545 Jetsonic 2000 Trade Name: Regulatory Class: III Product Code: KOJ Dated: May 18, 1999 May 20, 1999 Received:
Dear Mr. 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, 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. A 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 Failure to comply with the GMP regulation may such assumptions. result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: submission does not affect any obliqation 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.
Image /page/1/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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Page 2 - Mr. Coral
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 diaqnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4692. 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 Other general information on your responsibilities CFR 807.97). 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
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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INDICATIONS FOR USE STATEMENT
510(K) Number (if known): K 99 0545 Device Name: JETSONIC 2000 ULTRASONIC SCALER AND AIRPOLISHING UNIT
This unit combines both ultrasonic scaling and airpolishing functions in one compact unit that answers all prophylaxis needs. The air polishing function is intended to be used to remove stubbern stains, plaque and soft debris. The scaler funtions is intended to be used for cauculus removal. Device applications: Routine oral prophylaxis, routine polishing especially in hard to reach fissures and interproximal areas, prior to enamel etching and bonding techiniques and prior to bonding orthodontic bands and brackets.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Prescription Use
(Per 21CFR 801.109) or Over-the-Counter-Use
Coptional format
1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”