SP NEWTRON MODULE

K033764 · Satelec · ELC · Mar 1, 2004 · Dental

Device Facts

• Record ID: K033764
• Device Name: SP NEWTRON MODULE
• Applicant: Satelec
• Product Code: ELC · Dental
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Scaling - 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 o - Amalgam plugging o - · Loosening prostheses (bridge, crown, post, pivot ... ) Endodontia: - Canal preparation . - Canal cleaning . - Canal filling . - Gutta percha condensation . - Treatment resumption . - Retro surgery . - Micro retro surgery ● - Surface smoothing after burring ● Periodontia: - Root planing ● - Initial therapy . - Treatment of periodontal pockets . - Treatment of furcations . - Maintenance therapy t - Implant maintenance t

Device Story

SP NEWTRON Module is a piezoelectric ultrasonic scaling generator sub-assembly for integration into dental units. Device converts electrical energy into ultrasonic waves (28-36 kHz) via piezoelectric handpieces to induce cavitation at the tip. Used by dental professionals for scaling, restorative, endodontic, and periodontal procedures. Electronic control system automatically adjusts power output based on resistance encountered by the tip; ensures optimal performance and prevents handpiece overheating. Benefits include efficient deposit removal and safe sub-gingival work. Output is mechanical vibration of the scaling tip for clinical intervention.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use identical to the predicate device.

Technological Characteristics

Piezoelectric ultrasonic generator; frequency range 28-36 kHz. Modular sub-assembly for dental units. Features electronic automatic power control system based on tip resistance. Includes various interchangeable tips. Materials and components are consistent with predicate device (K972026).

Indications for Use

Indicated for dental patients requiring scaling, interdental/subgingival treatment, removal of deposits/stains, interproximal treatment, restorative/prosthetic procedures (inlay/onlay condensation, amalgam plugging, loosening prostheses), endodontic procedures (canal preparation/cleaning/filling, gutta percha condensation, retro surgery, surface smoothing), and periodontal procedures (root planing, pocket/furcation treatment, maintenance).

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

• SP 4055 and SP 4055 LUX Modules (K972026)

Submission Summary (Full Text)

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K033764

MAR - 1 2004

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

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

011 33 5 5634 0607 Telephone:

Pascal Dupeyron Contact Person: Requiatory Affairs

December 1, 2003 Date Prepared:

#### B. Device Identification

Piezoelectric Ultrasound Scaling Generator Common/Usual Name: Proprietary Name: SP NEWTRON Module

### C. Identification of Predicate Devices

The SP NEWTRON module is substantially equivalent to its predicate devices, SP 4055 and SP 4055 LUX Modules (K972026) from SATELEC previously cleared and currently marketed.

#### D. Device Description

The SP NEWTRON is a multi-purpose Piezoelectric Ultrasonic Scaling Generator sub-assembly which is an upgraded generation of the SP 4055 and SP 4055 LUX Modules from SATELEC that received 510(k) clearance for dental applications (K972026) on July 9, 1997. The SP NEWTRON maintains all the functions and the main components of the SP 4055 and SP 4055 LUX Modules. It is a stand-alone sub-assembly manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SP 4055 and SP 4055 LUX Modules products, which can be used in standard dental units. The indented use, technical performance, and clinical indications are identical to those of their predicate devices, the SP 4055 and SP 4055 LUX Modules (K972026).

The SP NEWTRON module is a multi-purpose ultrasonic generator to be marketed as a modular sub-assembly to OEM manufacturers of dental units. Each module is shipped with three standard tips, (# 1, # 2 and # 10P) but can be used with a variety of optional tips with up to 70 different models. According to clinical indications, the SP NEWTRON offers 3 setting ranges:

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- scaling, prosthesis conservative/restorative, .
- ultrasonic endodontic treatment, and .
- ultrasonic periodontal treatment. .

As the ultrasonic waves are produced by piezoelectricity, the SP NEWTRON hand pieces give off very little heat, making it possible for surgeons to perform both periodontal work (sub-gingival work at low power, where the absence of overheating is vital), as well as loosening (requiring high power, but without the unpleasant side-effect of a hot hand piece).

The SP NEWTRON, similar to its predicate devices, SP 4055 and SP 4055 LUX Modules (K972026) from SATELEC, operates from the action of cavitation, following the efficient propagation of ultrasound signals in a frequency spectrum comprised between 28 and 36 kHz.

The electronic automatic control system has the capability to adjust power instantaneously in function of the resistance encountered by the tip, and varies with hand-piece and tip frequency so as to optimize power output.

## E. Substantial Equivalence:

The technical characteristics of the SP NEWTRON are almost identical to those of the SATELEC SP 4055 and SP 4055 LUX Modules. Differences that exists between the above systems relating to technical specifications, materials, physical appearance, and control systems are minor and do not affect the relative safety or effectiveness of the SP NEWTRON relative to the SP 4055 and SP 4055 LUX Modules.

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Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus or a bird-like figure with three curved lines representing wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Mr. Pascal Dupeyron Regulatory Affairs SATELEC Z.l. Du Phare, BP 216 17. Avenue Gustave Eiffel 33708 Merignac Cedex. FRANCE

Re: K033764

Trade/Device Name: SP NEWTRON Module Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: December 1, 2003 Received: December 2, 2003

Dear Mr. Dupeyron:

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.

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Page 2 - Mr. Dupeyron

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 (OS) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clive Li, Ph.D.

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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33764

# Indications for Use

510(k) Number (if known): K033764

Device Name: SP Newtron Module

Indications For Use:

Scaling

- 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 o
- Amalgam plugging o
- · Loosening prostheses (bridge, crown, post, pivot ... )

Endodontia:

- Canal preparation .
- Canal cleaning .
- Canal filling .
- Gutta percha condensation .
- Treatment resumption .
- Retro surgery .
- Micro retro surgery ●
- Surface smoothing after burring ●

Periodontia:

- Root planing ●
- Initial therapy .

Prescription Use

- Treatment of periodontal pockets .
×

- Treatment of furcations .
- Maintenance therapy t
- Implant maintenance t

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muely for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

51D(k) Number:

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