← Product Code [EIH](/productcode/EIH) · K972648

# SONICSYS INLAY (K972648)

_Ivoclar North America, Inc. · EIH · Oct 30, 1997 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K972648

## Device Facts

- **Applicant:** Ivoclar North America, Inc.
- **Product Code:** [EIH](/productcode/EIH.md)
- **Decision Date:** Oct 30, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6660
- **Device Class:** Class 2
- **Review Panel:** Dental

## Indications for Use

Tooth colored restorations for proximal cavities prepared with Sonicsys instruments (Class II in the posterior region, Class III in canines)

## Device Story

Sonicsys Inlay system consists of specialized dental instruments used for cavity preparation; designed for proximal cavities; specifically Class II (posterior) and Class III (canines). System facilitates preparation for tooth-colored restorations. Used by dental professionals in clinical settings. Device functions as a mechanical preparation tool; output is a prepared cavity geometry suitable for inlay placement. Benefits include standardized cavity preparation for restorative procedures.

## Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

## Technological Characteristics

Mechanical dental instruments for cavity preparation. Specific materials and dimensions not detailed in provided text. Non-powered or sonic-driven manual/handpiece-integrated instruments.

## Regulatory Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

## Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 30 1997

Mr. Peter P. Mancuso Quality Assurance/Regulatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228

K972648 Re: Trade Name: Sonicsys Inlay Requlatory Class: II Product Code: EIH Dated: August 25, 1997 Received: Auqust 29, 1997

Dear Mr. Mancuso:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Mancuso

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy 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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। ﺴﻢ Page of

972648 510(k) Number (if known):

Sonicsys Inlay Device Name:

Indications For Use:

Tooth colored restorations for proximal cavities prepared with Sonicsys instruments (Class II in the posterior region, Class III in canines)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

|  | Super Ronger |
|--|--------------|
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(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices510(k) Number

Prescription Use (Per 21 CFR 801. 109)

OR

Over-The-Counter Use No

(Optional Format 1-2-96)

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**Source:** [https://fda.innolitics.com/device/K972648](https://fda.innolitics.com/device/K972648)

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