Periodontics Endodontics Scaling Prosthesis Please refer to the attached listing for a complete 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…) .

Device Description

The SUPRASSON P5 NEWTRON is a multi-purpose piezoelectric ultrasonic generator: it is an upgraded generation of the SUPRASSON P5 Booster Piezoelectric Ultrasonic Scaling Generators from SATELEC which received 510(k) clearance for dental applications (K961158) on May 23, 1996, including the technology of the SP NEWTRON module which received 510(K) clearance for dental applications (K033764) on March 1, 2004. The SUPRASSON P5 NEWTRON maintains all the functions and the key components of the SUPRASSON P5 Booster and SP NEWTRON Module; it is a stand-alone device manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SUPRASSON P5 Booster and SP NEWTRON module. The intended use, technical performance, and clinical indications are equivalent to those of their predicate devices, the SUPRASSON P5 Booster (K961158) and SP NEWTRON Module (K033764). The SUPRASSON P5 NEWTRON consists of three main components: the ultrasonic handpiece instrument, the control panel case, and the footswitch. The ultrasonic handpiece instrument (cleared by FDA - K033764) is held in the physician's hand, but it can also be stored in the holder located onto the case. The handpiece is connected to the control panel case via a fixed electrical cable connection.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device, nor does it detail a study that proves a device meets such criteria.

The document is a 510(k) summary for the "SUPRASSON P5 NEWTRON" piezoelectric ultrasound scaling generator, seeking FDA clearance. It describes:

Submitter Information: SATELEC, France.
Device Identification: SUPRASSON P5 NEWTRON, an ultrasonic scaler.
Predicate Devices: SUPRASSON P5 Booster (K961158) and SP NEWTRON Module (K0033764). The new device is stated to be substantially equivalent to these previously cleared devices.
Device Description: A multi-purpose piezoelectric ultrasonic generator, an upgraded generation maintaining functions and key components of the predicate devices. It consists of an ultrasonic handpiece instrument, control panel case, and footswitch.
FDA Clearance Letter: Confirms the 510(k) clearance for the SUPRASSON P5 NEWTRON (K050895) based on substantial equivalence to predicate devices.
Indications For Use: Specifies the dental applications in Periodontics, Endodontics, Scaling (prophylaxis), and Prosthesis (conservative/restorative).

The document focuses on establishing substantial equivalence to previously cleared devices for FDA marketing clearance, rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets) is not available in the provided text.

Summary

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Image /page/0/Picture/0 description: The image shows a date, "APR 2 0 2005". The month is April, the day is the 20th, and the year is 2005. The text is in a simple, sans-serif font and is horizontally aligned.

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K050895'. The characters are handwritten in a bold, dark font, giving them a clear and distinct appearance against the background. The style of writing suggests a casual or informal script.

SMDA Summary of Safety and Effectiveness - "510(k) Summary"

A Submitter Information
SATELEC 2.1. du Phare, BP 216 17. Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

011 33 5 5634 0607 Telephone:

Pascal Dupeyron Contact Person: Regulatory Affairs

March 15, 2005 Date Prepared:

B. Device Identification

Common/Usual Name:	Piezoelectric Ultrasound Scaling Generator
Proprietary Name:	SUPRASSON P5 NEWTRON

C. Identification of Predicate Devices
The SUPRASSON P5 NEWTRON is substantially equivalent to its predicate devices, SUPRASSON P5 Booster (K961158) and SP NEWTRON Module (K0033764) from SATELEC previously cleared and currently marketed.
D. Device Description
The SUPRASSON P5 NEWTRON is a multi-purpose piezoelectric ultrasonic generator: it is an upgraded generation of the SUPRASSON P5 Booster Piezoelectric Ultrasonic Scaling Generators from SATELEC which received 510(k) clearance for dental applications (K961158) on May 23, 1996, including the technology of the SP NEWTRON module which received 510(K) clearance for dental applications (K033764) on March 1, 2004. The SUPRASSON P5 NEWTRON maintains all the functions and the key components of the SUPRASSON P5 Booster and SP NEWTRON Module; it is a stand-alone device manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SUPRASSON P5 Booster and SP NEWTRON module. The intended use, technical performance, and clinical indications are equivalent to those of their predicate devices, the SUPRASSON P5 Booster (K961158) and SP NEWTRON Module (K033764).

The SUPRASSON P5 NEWTRON consists of three main components: the ultrasonic handpiece instrument, the control panel case, and the footswitch.

The ultrasonic handpiece instrument (cleared by FDA - K033764) is held in the physician's hand, but it can also be stored in the holder located onto the case. The handpiece is connected to the control panel case via a fixed electrical cable connection.

Image /page/0/Picture/16 description: The image shows the logo for Satelec Acteon group. The logo is black and white and features the word "SATELEC" in large, bold letters. Below the word "SATELEC" is the word "ACTEON" in a smaller font, followed by the word "group". There is a black shape above the word "SATELEC".

Image /page/0/Picture/18 description: The image shows a logo or certification mark. The text "EN ISO" is stacked on top of the number "13485". Below this, there is a stylized graphic that includes the letter "G". The text "-ARED" is located at the bottom of the graphic.

33 (0) 556 34 92 92 · E-mail: satelec@acteongroup.com · acteongroup.com 16 - 33708 MERIGNAC cedex · FRANCE · Tel + 33 (0) · RC Bordeaux B 782 016 240 · N' intracommunautaire FR 39 782 016 240 la Codenation des Anolhealtons des Techniques Electroniques · S.A.S. au capital de 1 309 548 €

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 2005

SATELEC C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K050895

Trade/Device Name: Suprasson P5 Newtron Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: April 8, 2005 Received: April 8, 2005

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have te reviewed your became in ined the device is substantially equivalent (for the referenced above and have acceminosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisere prior to that have been reclassified in accordance with the provisions of Amendinents, or to devroes that have of the end the equire approval of a premarket the rederal Pood, Drug, that Contrasy, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the rear stion, 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 If your device is classified (500 ass 1ditional controls. Existing major regulations affecting (FMA), it may of subject to back adon adam Regulations, Title 21, Parts 800 to 898. In your device can be found in the South nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DTC issuaires on that your device complies with other requirements Incall that IDA has made a actess and regulations administered by other Federal agencies. of the Act of ally I edelar status and I quirements, including, but not limited to: registration 1 our must comply with and the risbeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 007), labeling (QS) regulation (21 CFR Part 820); and if requirents as set forth in the qualify tion 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 his icter will anow you to begal finding of substantial equivalence of your device to a premiarket notification. - The PDF 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 desire specific ad rios to: Jour 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 other general miremational and Consumer Assistance at its toll-free Division of 01638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Ruone

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

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Indication for Use

510(k) Number (if known):

KOSO895

Device Name:

SUPRASSON P5 NEWTRON

Indications For Use:

Periodontics Endodontics Scaling Prosthesis

Please refer to the attached listing for a complete description.

X Prescription Use _ (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)

Sve Ruan

i Civision Sign-Off) Civicion of Anesthesiology, General Hospital, Intection Control. Dental Devices

(Q.4) Number: K456845

Page 1 of 2

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INDICATIONS FOR USE SATELEC SUPRASSON P5 NEWTRON

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…) .

Regulation Number and Section

§ 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.