(121 days)
Not Found
No
The summary describes a standard ultrasonic scaler with a peristaltic pump and foot control, and there is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is described as a Piezo Ultrasonic Scaler specifically for the removal of calculus deposits and stains from teeth, which is a therapeutic intervention.
No
The device is described as a scaler for removing calculus and stains from teeth, which is a treatment or prophylactic function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a main scaler unit, peristaltic water pump, hose, connector, and foot control switch.
No, 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, such as blood, urine, or tissue, to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Scaletron's Function: The Scaletron™ is a dental device used for the physical removal of calculus and stains from teeth. It operates directly on the teeth within the mouth.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the body. It is a therapeutic/procedural device, not a diagnostic one.
Therefore, based on the provided information, the Scaletron™ is a dental device used for treatment, not an IVD.
N/A
Intended Use / Indications for Use
The Scaletron ™ is a Piezo Ultrasonic Scaler intended for use in fast and reliable removal of light to heavy calculus deposits and stains from teeth.
Product codes
ELC
Device Description
The Scaletron ™ consists of the main scaler unit (including a peristaltic water pump), a hose, a connector for handpiece and a foot control switch. It is designed to generate regular linear tip movement at nominal 30 KHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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)
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
Pac-Dent International (Suzhou), Inc.
KO33120
510(k) Summary of Safety and Effectiveness
Submitter:
Pac-Dent International (Suzhou), Inc. 125 Binhe Road, New District of Suzhou City, Jiangsu Province, P. R. China Phone: 86-512-68085091 Fax: 86-512-68085092 Contact Person: Xu Wang US Agent Daniel Wang Phone: 909-839-0888 Fax: 909-839-0881 Date Summary Prepared: Sep.2003
Device Name:
Trade Name: ScaleTron™ Piezo Ultrasonic Scaler Common Name: Piezo Ultrasonic Scaler Classification Name: Scaler, Ultrasonic Classification: Class II
Devices for Which Substantial Equivalence is Claimed:
Deldent Ltd. Delsonic 2000TM
Device Description:
The Scaletron ™ consists of the main scaler unit (including a peristaltic water pump), a hose, a connector for handpiece and a foot control switch. It is designed to generate regular linear tip movement at nominal 30 KHz.
Intended Use of the Device:
The Scaletron ™ is a Piezo Ultrasonic Scaler intended for use in fast and reliable removal of light to heavy calculus deposits and stains from teeth.
1
Substantial Equivalence:
Scaletron™ Piezo Ultrasonic Scaler is substantially equivalent to the other legally marketed devices in the United States. Scaletron™ Piezo Ultrasonic Scaler functions in a same manner and is intended for the same use as the Delsonic 2000™ Piezo Ultrasonic Scaler (K014238) designed by Deldent Ltd.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2004
Pac-Dent International (SUZHOU), limited C/O Mr. Daniel Wang President Pac-Dent Interantional, Incorporated 21078 Commerce Pointe Drive Walnut, California 91789
Re: K033120
Trade/Device Name: SacleTron Piezo Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ulatrasonic Sacler Regulatory Class: II Product Code: ELC Dated: January 7, 2004 Received: January 8, 2004
Dear Mr. Wang:
We have reviewed your Section 510(k) promarket 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 adultcration.
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.
3
Page 2 - Mr. Wang
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 nean that I any Federal statutes and regulations administered by other Federal agencies. or the Fet of any ly with all the Act's requirements, including, but not limited to: registration 1 ou 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), r you acunted the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html
Sincerely vours.
Carl
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
4
Indications for Use
K033120 510(k) Number (if known):
Device Name: ScaleTron™ Piezo Ultrasonic Scaler
Indications for Use:
The Scaletron™ is a Piezo Ultrasonic Scaler intended for use in fast and reliable removal of light to heavy calculus deposits and stains from teeth.
Over-The-Counter Use AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Susan Russo
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
510(k) Number: Ko 33120