BENCO SPHERICAL

K031658 · Southern Dental Industries, Inc. · EJJ · Jul 29, 2003 · Dental

Device Facts

• Record ID: K031658
• Device Name: BENCO SPHERICAL
• Applicant: Southern Dental Industries, Inc.
• Product Code: EJJ · Dental
• Decision Date: Jul 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Silver based alloy dental restorative used in all classes of restorations.

Device Story

Benco Spherical is a silver-based dental amalgam alloy used by dental professionals for restorative procedures. It is indicated for all classes of dental restorations. The device functions as a restorative material to fill cavities and restore tooth structure. It is used in a clinical dental setting by dentists or trained dental staff. The material is placed into the prepared tooth cavity to provide a durable, functional restoration, benefiting the patient by repairing tooth decay or damage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silver-based dental amalgam alloy. Classified as Class II under 21 CFR 872.3050. Product code EJJ.

Indications for Use

Indicated for use as a silver-based alloy dental restorative for all classes of dental restorations.

Regulatory Classification

Identification

Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”*See* § 872.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2003

Ms. Samantha J. Cheetham Official Correspondent Southern Dental Industries, Incorporated 729 North Route 83, Suite 315 Bensenville, Illinois 60106

Re: K031658

Trade/Device Name: Benco Spherical Regulation Number: 21 CFR 872.3050 Regulation Name: Amalgam Alloy Regulatory Class: II Product Code: EJJ Dated: May 23, 2003 Received: May 28, 2003

Dear Ms. Cheetham:

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.

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 - Ms. Samantha J. Cheetham

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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 801), 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Patura Cucenite /loc

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation . Center for Devices and Radiological Health

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510(k) Number (if known):

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Device Name:

Indications For Use:

Benco Spherical

Silver based alloy dental restorative used in all classes of restorations.

Mirza Borne for MSR

(Divisich Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K031658

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:
(Per 21 CFR 801.109)

OR

Over-The-Counter Use: **__**
(Optional Format 1-2-96)