(62 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the device's intended use as an ultrasonic scaler.
No
A therapeutic device is one that treats a disease or health condition. This device is an Ultra Scaler used for dental procedures like scaling and crown removal, which are not therapeutic treatments but rather dental interventions.
No
The "Intended Use / Indications for Use" states the device is for therapeutic procedures like scaling, crown removal, and endodontic use, not for diagnosing a condition.
No
The intended use describes an "Ultra Scaler" which is a hardware device used for dental procedures. There is no mention of software as the primary component or function.
Based on the provided information, the AZ Ultrasonic System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "Ultra Scaler" for various dental procedures (scaling, crown removal, etc.). These are procedures performed directly on a patient's body, not on samples taken from the body for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The AZ Ultrasonic System is a medical device used for therapeutic and procedural purposes within the mouth, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for scaling, crown removal, amalgam condensation, excavating, periodontic or endodontic use.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
SEP 3 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howard Rowe Consultant J. Morita USA, Incorporated 9 Mason Irvine, California 92618
Re: K042056
Trade/Device Name: AZ Ultrasonic System Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: July 20, 2004 Received: July 30, 2004
Dear Mr. Rowe:
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 approvisions 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 (1 wr 1), it an 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.
1
Page 2 - Mr. Rowe
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 mean that I Dr I mas made statutes and regulations administered by other Federal agencies. or the Act of all 1 eden all the Act's requirements, including, but not limited to: registration r ou must comply with a 807); labeling (21 CFR Part 801); good manufacturing practice alle histing (21 CF R Part 801), and 100 ), and 100 (21 CFR Part 820); and if requirences as bet form 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) I mis letter will anon you The FDA finding of substantial equivalence of your device to a premaired notificated 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), If you desite specific at 11 Compliance at (240) 276-0115. 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 may obtain 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 yours,
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
2
Indications For Use Statement
| 510(k) Number (if known): | Not Assigned to date K0420520 |
|---|---|
| --------------------------- | ------------------------------- |
Device Name:
AZ Ultrasonic System
Indications For Use:
The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for scaling, crown removal, amalgam condensation, excavating, periodontic or endodontic use.
Susan Runne
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: C042056
(PLEASE DO NOT WRITE BELIOW 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
12