(90 days)
No
The device description focuses on piezoelectric ultrasound technology and user-controlled settings, with no mention of AI or ML capabilities. The "last settings are memorized" feature is a simple memory function, not indicative of AI/ML.
Yes
The device is described as an ultrasonic scaler with applications in periodontics, endodontics, scaling, and prosthesis, all of which are dental treatments aimed at maintaining or restoring oral health.
No
The device is an ultrasonic scaler used for dental treatments (periodontics, endodontics, scaling, prosthesis) and does not involve diagnosing medical conditions.
No
The device description clearly states it is an "ultrasonic scaler" that uses "piezoelectric ultrasound technology to generate mechanical microvibrations". It also mentions handpiece cord connectors, a keyboard, a multi-function footswitch, and a screen, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Piezotome™ is an ultrasonic scaler used by dental practitioners for mechanical procedures within the mouth (scaling, root planing, canal preparation, etc.). It operates directly on the patient's teeth and surrounding tissues.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the body. Its function is entirely mechanical and procedural.
Therefore, the Piezotome™ falls under the category of a dental device used for treatment and procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Indications for Use:
Periodontics Endodontics Scaling Prosthesis
Please refer to the attached listing for a detailed description.
Periodontics:
- Root planing .
- Initial therapy .
- Treatment of periodontal pockets .
- Treatment of furcations .
- Maintenance therapy .
- Implant maintenance
Endodontics: - Canal preparation ●
- Canal cleaning .
- Canal filling .
- Gutta percha condensation .
- Treatment resumption .
- Retro Surgery ●
- Micro Retro Surgery
Scaling (prophylaxis): - Interdental junction treatment .
- Tooth neck and subgingival treatment .
- Treatment of large deposits .
- Treatment of coating and tobacco stains ●
- Interproximal treatment .
Prosthesis (conservative/restorative): - . Inlay/onlay condensation
- ◆ Amalgam plugging
- Loosening prostheses (bridge, crown, post, pivot ... ) .
Product codes
ELC
Device Description
The Piezotome™ is an ultrasonic scaler for use by dental practitioners.
The Piezotome™ device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.
In Newtron® function, it can be used for mechanical ultrasound treatment in prophylaxis, periodontics, endodontics or prosthesis.
This device is fitted with two handpiece cord connectors. Depending on the application, the practitioner may connect two handpieces at the same time.
The Piezotome™ function offers four utilization modes at pre-set ultrasound power settings. In Newtron® function, the power of the ultrasound can be finely adjusted by the user.
| Range | Ultrasound power | Procedure |
|---|---|---|
| Green | Low | Periodontics mainly |
| Yellow | Medium | Endodontics mainly |
| Blue | High | Prophylaxis mainly |
| Orange | Very high | Prosthesis or Specific treatment modalities |
The user regulates the flow rate of the irrigation fluid.
The practitioner controls the device using a keyboard and a multi-function footswitch.
The irrigation fluid flow rate and the ultrasound power are monitored on a screen. For enhanced efficacy, the last settings are memorized by the machine.
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
Dental practitioners
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
3 2006 MAY
K060275 (p. 1 of 2)
-
- SMDA Summary of Safety and Effectiveness "510(k) Summary"
- A. Submitter Information SATELEC Z.I. du Phare, BP 30216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE
Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292
| Contact Person: | Steve Salesky |
|---|---|
| SATELEC | |
| c/o Acteon, Inc. | |
| 130 Gaither Drive, Suite 100 | |
| Mt. Laurel, NJ 08054 | |
| Telephone: 856 222-9988 Ext. 40 | |
| Fax: 856 222-4726 | |
| E-mail: steve.salesky@us.acteongroup.com |
Date Prepared: January 30, 2006
B. Device Identification
Common Usual Name: Ultrasonic scaler
Proprietary Name: Piezotome™
C. Identification of Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| Suprasson® P5 Newtron | Satelec | K050895 | April 20, 2005 |
The Satelec Piezotome™ is substantially equivalent to the predicate device by Satelec, the Suprasson® P5 Newtron (K050895) previously cleared by the FDA and currently marketed.
D. Device Description
The Piezotome™ is an ultrasonic scaler for use by dental practitioners.
The Piezotome™ device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.
In Newtron® function, it can be used for mechanical ultrasound treatment in prophylaxis, periodontics, endodontics or prosthesis.
This device is fitted with two handpiece cord connectors. Depending on the
1
application, the practitioner may connect two handpieces at the same time.
The Piezotome™ function offers four utilization modes at pre-set ultrasound power settings. In Newtron® function, the power of the ultrasound can be finely adjusted by the user.
| Range | Ultrasound power | Procedure |
|---|---|---|
| Green | Low | Periodontics mainly |
| Yellow | Medium | Endodontics mainly |
| Blue | High | Prophylaxis mainly |
| Orange | Very high | Prosthesis or Specific |
| treatment modalities |
The user regulates the flow rate of the irrigation fluid.
The practitioner controls the device using a keyboard and a multi-function footswitch.
The irrigation fluid flow rate and the ultrasound power are monitored on a screen. For enhanced efficacy, the last settings are memorized by the machine.
E. Substantial Equivalence
The Piezotome™ and the predicate device, Suprasson® P5 Newtron (K050895) are both ultrasonic scalers for use in conventional dentistry by trained dental practitioners. Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the Piezotome™.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
MAY 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SATELEC C/O Mr. Steve Salesky Regulatory Affairs Acteon, Incorporated 130 Gaither Drive, Suite 100 Mount Laurel, New Jersey 08054
Re: K060275
Trade/Device Name: Piezotome™ Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 30, 2006 Received: February 2, 2006
Dear Mr. Salesky:
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.
3
Page 2 - Mr. Steve Salesky
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and 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 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. 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 yours,
Carls
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
510(k) Number: