MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT

K012060 · Hu-Friedy Mfg. Co., Inc. · ELC · Jul 27, 2001 · Dental

Device Facts

• Record ID: K012060
• Device Name: MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
• Applicant: Hu-Friedy Mfg. Co., Inc.
• Product Code: ELC · Dental
• Decision Date: Jul 27, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used by Dental Professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth.

Device Story

Ultrasonic insert for dental cleaning and periodontal therapy; removes calculus from teeth. Device features swivel mechanism allowing rotational movement during use. Input: manual manipulation by dental professional; Output: ultrasonic vibration for scaling. Used in dental clinics by dental professionals. Swivel mechanism utilizes stainless steel and resin components to facilitate grip and tip transition. Benefits include improved ergonomics and ease of use during scaling procedures. Clinicians maintain control of device; no autonomous operation.

Clinical Evidence

Field evaluation conducted with clinicians to assess scaling effectiveness, vibration, water delivery, swivel function, and grip. Results indicated the device met clinical requirements and provided clinicians with complete control during use. Laboratory testing included cleaning, sterilization, and mechanical life testing.

Technological Characteristics

Ultrasonic scaler insert. Materials: stainless steel and resin components. Features a swivel mechanism for rotational movement. Designed for use with ultrasonic scaling equipment. Sterilization required for dental instruments.

Indications for Use

Indicated for dental professionals performing dental cleaning and periodontal therapy to remove calculus from the 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

• Hu-Friedy Ultrasonic Scaler Insert (K953919)

Submission Summary (Full Text)

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JUL 27 2001

K012060

## 510(k) SUMMARY

Submitter

Keith Dunn Hu-Friedy Mfg. Co., Inc. 3232 N. Rockwell St. Chicago, IL 60618 Tel. [phone] Fax [phone]

6/29/01 Date Prepared

Device Name

| Trade name | Satin Swivel™ Ultrasonic Insert |
|---------------------|---------------------------------|
| Common name | Ultrasonic Insert |
| Classification name | Ultrasonic Scaler |

Legally marketed Device to which equivalence is claimed

Hu-Friedy Ultrasonic Scaler Insert K953919

Description of the device

The Hu-Friedy® brand Satin Swivel™ ultrasonic insert is similar to the predicate device with the addition of a swivel mechanism allowing for ease of rotational movement during dental cleaning procedures.

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

The Satin Swivel™ ultrasonic insert has essentially the same internal design as the predicate device except for the addition of several stainless steel and resin components. The steel components enable the insert tip to swivel. The two different resin components allow for a positive grip for the dental professional and a smooth cone to tip transition for ease of use.

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To determine if the Satin Swivel™ ultrasonic insert performed similar to or better than the predicate device both laboratory and a field evaluation were undertaken. The laboratory tests included cleaning, sterilization, and mechanical life testing. For the field study clinicians were asked to evaluate the inserts as related to scaling effectiveness, vibration, water delivery, swivel function, and grip. The overall conclusion of this evaluation was that both the Satin Swivel™ and the predicate device met their clinical requirements. The clinicians had complete control of the Satin Swivel™ ultrasonic insert and it did not turn on its own while in use.

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Image /page/2/Picture/2 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 7 2001

Mr. Keith Dunn Manager of Regulatory Affairs Manager of Regulacor), Incorporation 3232 North Rockwell Street Chicago, Illinois 60618

K012060 Re : Hu-Friedy Brand Satin Swivel Trade/Device Name: Ultrasonic Insert Regulation Number: 872.4850 Regulatory Class: II Product Code: ELC Dated: June 29, 2001 July 2, 2001 Received:

Dear Mr. Dunn:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beceren above and we have determined the market the device fererenous above indications for device is subblancially ore) to legally marketed predicate use stated in the chorobase, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che enactment date or choclassified in accordance with the devices that have been al Food, Drug, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmetic the general provisions of the reactur rood, bray, asubject to the general The general controls controls provisions of the Act. controls provisions of include requirements for annual provisions of the not insteasines, 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 (Premarket Approval), it may (Special Concrols) additional controls. Existing major be subject to bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal hegaturents. Ifree termination assumes compliance with subscancially equivalence aring Practice requirements, as set the Current Sood handsustem Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, beview. Scholar QS inspections, the Food and Drug chrough periodic go inbecurity such assumptions. Failure to Administration (121) Egulation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 - Mr. Dunn

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________ of

510(k) Number (if known): K012060

Device Name: Hu-Friedy Brand Satin Swivel Ultrasonic Insert

Indications For Use:

To be used by Dental Professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runser

Division Sign-Off) ison of Dental, Infection Control, Caneral Hospital Devices Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)