SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS

K053178 · Hu-Friedy Mfg. Co., Inc. · ELC · Feb 1, 2006 · Dental

Device Facts

• Record ID: K053178
• Device Name: SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS
• Applicant: Hu-Friedy Mfg. Co., Inc.
• Product Code: ELC · Dental
• Decision Date: Feb 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used by Dental Professionals during dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the teeth by application of an ultrasonic vibrating tip to the teeth.

Device Story

Symmetry S-Series Piezo Scaling Tips are dental ultrasonic inserts used by dental professionals for cleaning and periodontal therapy. The device attaches to a compatible ultrasonic handpiece; it transforms electrical energy into mechanical vibration at a resonant frequency of 27-32 kHz. This vibration, combined with linear tip displacement, allows for the removal of calculus, plaque, and staining from tooth surfaces. Used in clinical dental settings, the tips are designed to be compatible with existing piezoelectric ultrasonic generators. The healthcare provider manually manipulates the tip against the tooth surface; the device's performance directly impacts the efficiency of calculus removal and patient comfort during the procedure.

Clinical Evidence

Bench testing and a clinical field evaluation were performed. Bench testing included cleaning, sterilization, and mechanical life testing to verify design compatibility (resonant frequency and tip displacement). The field evaluation involved clinicians comparing the Symmetry S-Series tips to predicate tips across metrics including scaling efficiency, tooth surface adaptability, water delivery, and patient comfort. Results indicated the subject tips were perceived as equal to or slightly better than the predicate devices.

Technological Characteristics

Piezoelectric ultrasonic scaling tips. Operates at a resonant frequency of 27-32 kHz. Features linear tip displacement consistent with generator power output. Designed for compatibility with specific ultrasonic handpiece thread specifications. Sterilization required for clinical reuse.

Indications for Use

Indicated for dental professionals performing dental cleaning and periodontal therapy to remove calculus, plaque, and staining from teeth.

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

• Satelec Suprasson P-Max (K942139)
• Satelec Suprasson P5 Booster (K961158)

Submission Summary (Full Text)

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FEB 1 2006

K053178

## 510(k) SUMMARY

| Submitter | Keith Dunn<br>Hu-Friedy Mfg. Co., Inc.<br>3232 N. Rockwell St.<br>Chicago, IL 60618<br>Tel. [phone] Fax [phone] |
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Date Prepared

11/01/05

Device Name

Trade name Common name Classification name

Symmetry S-Series Piezo Scaling Tips Dental Ultrasonic Scaler Ultrasonic Scaler

Legally marketed Devices to which equivalence is claimed:

| Satelec Suprasson P-Max | K942139 |
|------------------------------|---------|
| Satelec Suprasson P5 Booster | K961158 |

Description of the device

The Hu-Friedy® brand Symmetry S-Series Piezo Scaling Tip is similar to the Piezo Scaling Tips used with the predicate devices listed above.

This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth.

The Symmetry S-Series ultrasonic insert has essentially the same design as the predicate device's ultrasonic inserts. Laboratory tests performed to make this determination include cleaning, sterilization, and mechanical life testing. The key elements of piezoelectric ultrasonic tip compatibility include: correspondence of tip thread to hand-piece specification, tip vibration at resonant frequency established by equipment specification,

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(27-32 kHz) and a linear tip displacement in a range consistent with the power output setting on the generator. At the conclusion of engineering design control testing, it was found that critical clements of design, resonant frequency and tip displacement are compatible with the predicate device's tips.

To determine if the Symmetry S-Series ultrasonic insert performed similar to or better than the predicate device, a field evaluation was undertaken. For the field study, clinicians were asked to evaluate the inserts as related to scaling efficiency, adaptability to the tooth surface, water delivery, patient comfort during use and overall preference. The overall conclusion of this evaluation was that the Symmetry S-Series tips were perceived to be equal to, or slightly better than the predicate device's competitive tip.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 2006 FEB I

Mr. Keith Dunn Regulatory Affairs Hu-Friedy Manufacturing Company, Incorporated 3232 North Rockwell Street Chicago, Illinois 60618

Re: K053178

Trade/Device Name: Symmetry S-Series Piezoclectric Scaling Tips Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 17, 2005 Received: November 17, 2005

Dear Mr. Dunn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Dunn

Please be advised that FDA's issuance of a substantial equivalence determination documot 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) gegulation (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 £21), 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-firee number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Sviette y. N. Mclian Omd.

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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K053178

## Indications for Use

510(k) Number (if known): ..........................................................................

Device Name: Symmetry S-Scries Piczoclectric Scaling Tips

Indications for Use:

To be used by Dental Professionals during dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the tecth by application of an ultrasonic vibrating tip to the teeth.

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

Siber Runoe

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KC53178