(29 days)
Not Found
Not Found
No
The document describes a standard ultrasonic scaler and contains no mention of AI, ML, or related concepts.
Yes
The device is intended for the removal of calculus and plaque, which are medical treatments for oral health, making it a therapeutic device.
No
Explanation: The device is an ultrasonic scaler intended for the removal of calculus and plaque, which is a treatment function, not a diagnostic one.
No
The device description clearly identifies it as an "Ultrasonic Scaler," which is a hardware device that uses ultrasonic vibrations for calculus and plaque removal. The summary does not mention any software component as the primary or sole function of the 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 clearly states it's for the "removal of light to heavy calculus and plaque." This is a procedure performed directly on a patient's teeth, not on a sample of biological material in vitro (outside the body).
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The Delsonic 2000 is a dental device used for a physical procedure (scaling) within the mouth.
N/A
Intended Use / Indications for Use
The Delsonic 2000 Ultrasonic Scaler is intended to be used for fast and reliable removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system.
Product codes
ELC
Device Description
Not Found
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2002
Mr. Alan Edel Joint C.E.O Deldent Limited 19 Keren Kayemet Street Petach, Tikvah, ISRAEL
Re: K014238
Trade/Device Name: Delsonic 2000 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: November 27, 2001 Received: December 26, 2001
Dear Mr. Edel:
We have reviewed your Section 510(k) premarket 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 adulteration.
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.
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
1
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and regareents, including, but not limited to: registration You must comply with an the Act 3 requirements and 1); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsung (21 CFR Part 807), laceming (21 cms (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality by occases (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 I his letter will and w you to begin manteening your substantial equivalence of your device to 310(K) premarket nonication: The I Brivaina 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 II you desire specific ad rios for your for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 607.10 103 ... Additionally, for questions on the promotion and
Office of Compliance at (301) 594-4613. Additionally, for questions on the promo Office of Comphance at (301) 591 - 1231 - 123 - 12 - 12 - 12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 6 - - - 6 - advertising of your as note the regulation entitled, "Misbranding by reference to premarket Also, prease note the rogulation one other general information on your responsibilities under notification (ZTCFR Part 00197). Gailer Jan 2019 - 12:10 PM (2019) 142 - 667 the Act may be obtained from the Driver - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Internet address http://www.fda.gov/cdrh/dsma/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
2
K014238
LABELING
Page 1 of 1
510(k) Number (if known): _ Unknown
Delsonic 2000 Ultrasonic Scaler Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Delsonic 2000 Ultrasonic Scaler is intended to be used for fast and reliable The Delsonic 2000 Ultrasonic Scaler 15 Interded This 29KHz Ultrasonic system
removal of light to heavy calculus and plaque. This 29KHz Ultrasonic system
removal of light to h removal or light to tight to time for each scaling insert.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEWS OF NOT WRITE DELOW - NEEDED) NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
سا Prescription Use_ Per 21 CFR801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Susan Ryan
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devicess 510(k) Number _