NEWTRON BOOSTER

K131997 · Satelec - Acteon Group · ELC · Nov 26, 2013 · Dental

Device Facts

• Record ID: K131997
• Device Name: NEWTRON BOOSTER
• Applicant: Satelec - Acteon Group
• Product Code: ELC · Dental
• Decision Date: Nov 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).

Device Story

Dental ultrasonic generator; uses piezoelectric technology to drive dental handpieces (NEWTRON or NEWTRON SLIM) with attached ultrasonic instruments. Operated by dental professionals in clinical settings. Input: electric power supply; Output: ultrasonic micro-vibrations and irrigation flow for dental procedures. Device facilitates removal of calculus, plaque, and debris; aids in periodontal and endodontic therapy. Clinical benefit: efficient dental prophylaxis and restorative preparation.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological characteristics, materials, and performance specifications to legally marketed predicate devices.

Technological Characteristics

Piezoelectric ultrasonic generator; utilizes self-extinguishing casing material (UL94V-0). Energy source: electric power supply. Output: ultrasonic micro-vibration. Compatible with Satelec NEWTRON and NEWTRON SLIM handpieces. Single-function footswitch control. No software-based algorithm or connectivity described.

Indications for Use

Indicated for dental patients requiring scaling (prophylaxis), periodontal treatment, endodontic procedures, or prosthetic preservation and restoration dentistry.

Regulatory Classification

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.

Predicate Devices

• SUPRASSON P5 NEWTRON (K020892)
• ProUltra Piezo Ultrasonic (K113430)

Submission Summary (Full Text)

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# Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - September 17, 2013

This Summary of Safety And Effectiveness is submitted in accordance with 21 CFR 807.92.c.

#### 01 - Administrative Information

01- a. Type of 510(k) submission:

These documents constitute a Traditional 510(k) Submission.

June 24, 2013 Submission date: 01- b.

**NOV** 26 2013

510(k) Submitter 01-c.

SATELEC 17, Avenue Gustave Eiffei BP 30216 33708 Merignac Cedex France 011-33-556-340-607 Telephone: [phone] Fax: [e-mail] E-Mail:

01-d. Contact Person:

Rick Rosati SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 800-289-6367 Ext. 390 Telephone: [phone] Fax: [e-mail] E-Mail:

8044015 01- e. Establishment Registration Number:

#### 02 - Device Information

| 02-a. Trade Name of Device: | NEWTRON BOOSTER |
|----------------------------------|-------------------|
| 02-b. Common Name of Device: | Ultrasonic Scaler |
| 02-c. Classification Regulation: | 21 CFR 872.4850 |
| 02-d. Medical Device Class: | II |
| 02-e. Panel: | Dental |
| 02-f. Product Code: | ELC |

Pre-Market Notification 510(k) Submission for NEWTRON BOOSTER By SATELEC Kel Nodification of Offy - Confidential Document - Version 01 006 - 1

Image /page/0/Picture/16 description: The image shows a stylized letter G above the text "ISO 13485". The letter G is large and bold, and the text is smaller and located below the letter. The text appears to be a certification or standard identifier.

Image /page/0/Picture/17 description: The image shows the logo for Satelec Acteon. The word "ACTEON" is written in large, bold, black letters. Above the right side of the word "ACTEON" is the word "SATELEC" in smaller letters. To the left of the word "ACTEON" is a black curved line.

SATELEC . A company of ACTEON Group Gustave Elifel . BP 30216 . 33708 MERICNAC cedex . FRANCE
Tel + 33 (0) 556 34 06 07 . Fax + 33 (0) 556 34 97 92 av. Gustave E-mail: [e-mail] . www.acteongroup.com Société pour la Conception des Applications des Techniques Electroniques • 5.A.S. au capRel de 1 309 548 6. R.C. Bordelux 8 782 016 240 · N' intracommunataire FR 39 782 016 240

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# Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - September 17, 2013

## 03 - Identification of Legally Marketed Predicate(s)

The Substantial Equivalence (SE) of the Satelec New Device is based on the Predicate Devices identified in the Table 01.

| Trade Name | Manufacturer | Product<br>Code | 510(K)<br>number | Date Cleared |
|---------------------------|--------------|-----------------|------------------|-------------------|
| SUPRASSON P5 NEWTRON | SATELEC | ELC | K020892 | April 20, 2005 |
| ProUltra Piezo Ultrasonic | SATELEC | ELC | K113430 | February 23, 2012 |

# Table 01 - Identification of Legally Marketed Predicate Devices

## 04 - Description of the Device

The Satelec New Device is a Dental Ultrasonic Generator. The Sateler New Device uses Piezoelectric Technology.The Satelec New Device uses a Satelec Dental Piezoelectric Plezonecht - Technology. The Satelec New Device can use the same Handpiece Harroplece (NEWTRON OElin). In Option the School (K050895, cleared April 20, 2005).

The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with The Satelec New Device is Gesigned to be association of the St. 430, cleared February 23, 2012) or other new Satelec Dental Tips.

#### 05 - Intended Use

The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).

# 06 - Technological characteristics of the Device compared to the Predicate Devices

Technological characteristics of the Satelec New Device are the same as the Predicate Device.

# Technological Perspective:

The Satelec New Device and the Predicate Devices use the same technology (Piezoelectricity Technology).

### Material perspective:

Marelial Device and the Predicate Devices are very similar because the casings are made in self-extinguishing material (UL94V-0).

Pre-Market Notification 510(k) Submission for NEWTRON BOOSTER By SATELEC ket Notification 310(k) - Confidential Document - Version 01

006 - 2

Image /page/1/Picture/18 description: The image shows the logo for Satelec Acteon. The word "ACTEON" is written in large, bold, black letters. Above and to the right of "ACTEON" is the word "SATELEC" in smaller letters. A curved line is to the left of the word "ACTEON".

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# Section 006 - 510/k) Summary (SMDA Requirements)

Additional Information - September 17, 2013

Design perspective:

The Satelec New Device and the Predicate Devices use:

- The same Principle of User interface. .
- The same Dental Ultrasonic Handpiece (Satelec NEWTRON Handpiece) and / or a derivated Dental Ultrasonic Handpiece (Satelec NEWTRON SLIM Handpiece).

Energy source perspective:

The Satelec New Device and the Predicate Devices:

- Use the same input energy source (Electric Power Supply). -
- Deliver the same output energy source (ultrasonic micro-vibration). *
- Deliver the same Handpiece Current Values. "
- Deliver a similar irrigation Flow values. -

# 07 - Determination of substantial equivalence

The Satelec New Device Indications for Use is similar to the Satelec Predicate Devices. The The Gateleo Non Device is the Satelec Predicate Devices in terms of functioning orinciple.

The Satelec New Device uses a Satelec NEWTRON SLIM Dental Piezoelectric Handpiece. The Satelec NEWTRON SLIM Dental Piezoelectric Handpiece is based on the Satelec Predicate Satelec NEWTRON P5 NEWTRON (K050895, cleared April 20, 2005) and Satelec ProUltra Devices SOT KAOON 1 D Newrod February 23, 2012) (same materials, same Piezoeledric Fransducters). Also, the Satelec New Device can be used with Satelec NEWTRON Handplece employed with SUPRASSON P5 NEWTRON (K050895, cleared April 20, 2005)

From external structure perspective, the Satelec New Device and Predicate Devices are very From external structure perspourve, the Sating How material (UL94-V0). Also, Satelec New Device and Satelec Predicate Devices use a single function footswitch.

Moreover, the materials in contact to the patient are the same.

### 08 - Conclusion

The Satelec New Device is the same as the identified Predicate Devices in terms of Indication For Use.

Because of the used technologies, characteristics and performances are similar to the Satele Predicate Devices, the characteristics of the Sateler New Device do not affect the Safety of the Predicate Devices, the onarcelenenes of the Effectiveness is the same as of the Predicate Devices.

There is no doubt that the Satelec New Device is Substantially Equivalent (SE) of the Satelec There is no dobb that the Gated February 23, 2012) and Satelec SUPRASSON P5 NEWTRON (K050895, cleared April 20, 2005).

End of Section

Pre-Market Notification 510(k) Submission for NEWTRON BOOSTER By SATELEC K131997 - Traditional 510(k) - Confidential Document - Version 01 006 - 3

Image /page/2/Picture/23 description: The image shows a logo with the letter G in a bold, stylized font. Below the letter G, the text "ISO 13485" is written in a smaller, sans-serif font. The logo appears to be a certification mark, possibly indicating compliance with the ISO 13485 standard for quality management systems in the medical device industry.

Image /page/2/Picture/24 description: The image shows the logo for Satelec Acteon. The word "ACTEON" is in large, bold, black letters. Above and to the right of "ACTEON" is the word "SATELEC" in smaller, less bold letters. To the left of "ACTEON" is a curved line that resembles a crescent moon.

SATELEC . A company of ACTEON Group 17 av. Gustave Eiffel + BP 30216 + 33708 MERKGNAC cedex + FRANCE
E-mail: [e-mail] · www.acteongroup.com Société pour la Conception des Applications des Techniques Electroniques » 5.A.S. Iu capital de 1 309 548 € R.C. Bordeaux B 782 016 240 · Nº Intracommunautaire FR 39 782 016 240

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# Section 006 - 510(k) Summary (SMDA Requirements)

Additional Information - September 17, 2013

This page is intentionally left in blank

Pro-Market Notification 510(k) Submission for NEWTRON BOOSTER By SATELEC Kel NotifiedIon B10(k) - Confidential Document - Version 01 006 - 4

Image /page/3/Picture/4 description: The image shows the text "ISO 13485" in a sans-serif font. Above the text is a large letter "G" in bold font. The letter "G" is slightly tilted to the right. The text and the letter "G" are in black color.

SATELEC
ACTEON

17 av, Gustave SATELE - A Conquily of ACTEON Grap

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing the branches of the department.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### November 26, 2013

Satelec-Acteon Group Mr. Rick Rosati Quality Manager C/O ACETON, Incorporated 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054

Re: K131997

Trade/Device Name: NEWTRON BOOSTER Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: November 1, 2013 Received: November 4, 2013

Dear Mr. Rosati:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor YowIndustry/default.htm.

Sincerely yours,

Image /page/5/Picture/7 description: The image shows the name "Kwame Ulmer" in a stylized font. The name "Kwame" is stacked on top of "Ulmer" on the left side of the image. To the right of the name is a logo that includes the letters "EDA" and a triangle shape.

for

Erin Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 005 - Indication for Use Additional Information - September 17, 2013

#### Indications for Use

510(k) Number (if known):_K131997

Device Name:

:

NEWTRON BOOSTER

Indications for Use:

The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).

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) Kwame O. Ulmerss 2013.11.27 15:58 469 0500

Concurrence of CDRH, Office of Device Evaluation (ODE)

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