← Product Code [EMA](/productcode/EMA) · K981618

# LIQUID A (K981618)

_Harry J. Bosworth Co. · EMA · Jul 28, 1998 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K981618

## Device Facts

- **Applicant:** Harry J. Bosworth Co.
- **Product Code:** [EMA](/productcode/EMA.md)
- **Decision Date:** Jul 28, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Indications for Use

LIQUID A is intended to be used with Alumina Zinc Oxide Powder to set as a temporary or permanent cement, or as a base or liner in a dental restoration

## Device Story

Liquid A is a dental material component intended for mixing with Alumina Zinc Oxide Powder. The mixture functions as a dental cement, base, or liner for restorations. It is used in a clinical dental setting by licensed dental professionals. The device facilitates the setting of restorative materials, aiding in the stabilization or protection of dental structures during or after restorative procedures.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Liquid component for dental cement; intended for use with Alumina Zinc Oxide Powder. Class II device (Product Code: EMA).

## Regulatory Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 1998

Ms. Mildred M. Goldstein ·President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076-3999

K981618 Re : Liquid A Trade Name: Regulatory Class: II Product Code: EMA Dated: April 10, 1998 Received: May 6, 1998

Dear Ms. Goldstein:

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 The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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

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Page 2 - Ms. Goldstein

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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) 594-4692. 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 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,

Patina Cuceniti //for

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

Enclosure

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Page _ 1_of _1

510(k) Number: K981618

Device Name: "LIQUID A

INDICATIONS FOR USE:

"LIQUID A is intended to be used with Alumina Zinc Oxide Powder to set as a temporary or permanent cement, or as a base or liner in a dental restoration".

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

,一

OR

Over-the-Counter Use

(Optional Format 1-2-96)

Suser Rumm

(Division Sign - Off) Division of Dontal. Infection Control, and General Hospital Devices 510(k) Number

CONFIDENTIAL

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