(90 days)
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 ... ) .
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.
This document is a 510(k) Summary for the SATELEC Piezotome™ ultrasonic scaler, which seeks to prove substantial equivalence to a predicate device, the Suprasson® P5 Newtron (K050895). As such, it does not contain the information requested for a detailed study description with acceptance criteria, sample sizes, expert qualifications, and comparison to AI performance. This type of regulatory document primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed scientific study with defined acceptance criteria and performance metrics in the way you've outlined.
Therefore, many of the requested fields cannot be filled from the provided text.
Here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. The basis for clearance is "substantial equivalence" to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a regulatory submission for substantial equivalence, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment from experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ultrasonic scaler; it is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No such ground truth data is presented. The "ground truth" for regulatory clearance is the performance and safety established for the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information related to the device and its regulatory clearance:
- Device Name: Piezotome™
- Device Type: Ultrasonic scaler
- Predicate Device: Suprasson® P5 Newtron (K050895) by Satelec
- Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "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™."
- Operating Modes/Power Settings:
- Green: Low (Periodontics mainly)
- Yellow: Medium (Endodontics mainly)
- Blue: High (Prophylaxis mainly)
- Orange: Very high (Prosthesis or Specific treatment modalities)
- Indications for Use (from Enclosure):
- 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).
In conclusion, the provided document is a regulatory submission demonstrating substantial equivalence, not a detailed study report with the specific metrics and study design elements you requested.
{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 Specifictreatment 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:
<060275
Device Name:
Piezotome™
Indications for Use:
Periodontics Endodontics Scaling Prosthesis
Please refer to the attached listing for a detailed description.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulvey for MSP
i)
Anesthesiology, General Hospital,
Control, Dental Devices
Page 1 of 2
{5}------------------------------------------------
INDICATIONS FOR USE Piezotome™
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 ... ) .
Susan Roarer
i And Hosistogy, General Hospital, in Connol. Dental Devices
Page 2 of 2
§ 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.