BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP

K103585 · Harry J. Bosworth Co. · EMA · Mar 4, 2011 · Dental

Device Facts

• Record ID: K103585
• Device Name: BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP
• Applicant: Harry J. Bosworth Co.
• Product Code: EMA · Dental
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bosworth AEGIS Liner & Restorative Material is used as a light-cured radio-opaque cavity liner and pulp capping material, and, with the addition of tooth shades, as a class V restorative material.

Device Story

AEGIS Liner & Restorative Material w/ACP is a light-cured dental material; functions as a radio-opaque cavity liner and pulp capping agent; also used as a class V restorative material when provided in tooth shades. Applied by dental professionals in a clinical setting; material is placed into prepared tooth cavities and cured using a dental light source. Provides structural support and protection for dental pulp; aids in cavity restoration. Benefits include radio-opacity for radiographic identification and restorative utility for class V lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured resin material containing Amorphous Calcium Phosphate (ACP). Radio-opaque. Formulated for use as a cavity liner, pulp capping agent, and class V restorative material. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for use as a light-cured radio-opaque cavity liner, pulp capping material, and class V restorative material in dental patients requiring cavity lining or restoration.

Regulatory Classification

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Gary Chuven Quality & Regulatory Manager Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076

MAR - 4 2011

Re: K103585

Trade/Device Name: AEGIS Liner & Restorative Material w/ACP Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EMA, EBF Dated: November 19, 2010 Received: December 7, 2010

Dear Mr. Chuven:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Chuven

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony O. Runa

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(K) Number: K163585

## Device Name: AEGIS Liner & Restorative Material w/ACP

## INDICATIONS FOR USE:

Bosworth AEGIS Liner & Restorative Material is used as a light-cured radio-opaque cavity liner and pulp capping material, and, with the addition of tooth shades, as a class V restorative material.

(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) X

R.S.Beta, DDS for Dr. S. Runner

Over-the Counter Use (Division Sign-Off) (Optional Format 1/2/96)
(Division Sign-Off) (Optional Hospital (Division Sign-Oh) (Open Sthesiology, General Hospital Division of ontrol, Dental Devices

510(k) Number: K103585.