COMPUDENT STA

K061904 · Milestone Scientific, Inc. · EJI · Aug 8, 2006 · Dental

Device Facts

• Record ID: K061904
• Device Name: COMPUDENT STA
• Applicant: Milestone Scientific, Inc.
• Product Code: EJI · Dental
• Decision Date: Aug 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.

Device Story

CompuDent STA™ Syringe is a computer-controlled injection system for dental anesthesia. It consists of a stationary motor housing and a metal piston. The system uses a foot switch to regulate the piston's speed, thereby controlling the flow rate of the anesthetic. The device accepts standard 1.8mm pre-filled carpules and hypodermic needles, connected via flexible vinyl tubing. The handpiece is constructed of rigid PVC. The holster, tubing, and handpiece are provided as a sterile, single-use disposable assembly. The device provides audible and visual feedback regarding injection rate, remaining anesthetic volume, and pressure at the needle tip. It is operated by dental professionals to deliver anesthesia, with the computer control intended to provide consistent delivery compared to manual syringes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Computer-controlled motor-driven piston system. Materials: rigid PVC handpiece, flexible vinyl tubing, metal piston. Form factor: stationary motor housing with disposable sterile assembly (holster, tubing, handpiece). Energy source: electric (motor). Connectivity: none. Sterilization: disposable components provided sterile.

Indications for Use

Indicated for subcutaneous or intramuscular injection of local anesthetic agents in dental applications.

Regulatory Classification

Identification

A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Predicate Devices

• CompuDent™ computer controlled syringe

Submission Summary (Full Text)

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K061904

510(k) Summarv

Submitted by:

Daniel J. Manelli Manelli & Fisher, P.L.L.C. 5335 Wisconsin Ave., NW (Suite 440) Washington, DC 20015

Telephone: [phone]

On behalf of Milestone Scientific, Inc. 220 South Orange Avenue Livingston, NJ 07039

510(k) Submission: CompuDent STA™ Syringe Date: July 5, 2006

Description: The CompuDent STA™ Syringe is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible and visible status indicators of injection rate, amount of anesthetic remaining in the carpule, and pressure at the tip of the needle. It is substantially equivalent to the company's currently marketed CompuDent™ computer controlled syringe.

Indications for Use:

To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.

AUG - 8 2006

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES". In the center of the seal is an abstract image of an eagle.

AUG - 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Milestone Scientific, Incorporated C/O Mr. Daniel J. Manelli Attorney Manelli & Fisher, P.L.L.C 5335 Wisconsin Avenue NW, Suite 440 Washington, D.C. 20015

Re: K061904

Trade/Device Name: CompuDent STA™ Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: July 5, 2006 Received: July 5, 2006

Dear Mr. Manelli:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rown 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 nucesure connects, or to devices that have been reclassified in accordance with the provisions of Amendments, of to arrivand Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 000; Drag, are grand you may, therefore, market the device, subject to the general approvisions 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 (I Wry, It may of bacycer to easily of Federal Regulations, Title 21. Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Ecderal Register.

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## Page 2 - Mr. Manelli

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 (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.

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]. 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 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/industry/support/index.html.

Sincerely yours,

Syvette y. Michael DMD.

Chiu Lin, Ph.D. 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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Exhibit 4

510(k) Number (if known):

Device Name:

CompuDent STA™

Indications for Use:

To inject local anesthetic agents subcutaneously or intramuscularly for dental applications

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation

Suger Rurre

Off) lion Sign-ംon of Anesthesiology, General Hospital, otion Control, Dental De

Number: KO(0)904

Prescription Use J (Per 21 CFR 801.1091)

Over-The-Counter Use

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