MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT

K083796 · Miltex, Inc. · EJI · Mar 9, 2009 · Dental

Device Facts

• Record ID: K083796
• Device Name: MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
• Applicant: Miltex, Inc.
• Product Code: EJI · Dental
• Decision Date: Mar 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

Device Story

Miltex® Dental Aspirating Syringes are manual, reusable dental instruments designed for the delivery of anesthetic solutions. The product line includes standard, petite, self-aspirating, lightweight self-aspirating, and articulating barrel models. Constructed from chrome-plated brass, stainless steel, and aluminum, these syringes are designed for use by dental clinicians. The device functions by holding an anesthetic cartridge and needle, allowing the clinician to manually inject anesthetic solution into the oral cavity. The aspiration feature allows the clinician to verify needle placement prior to injection. The devices are supplied non-sterile and require sterilization by the user before clinical application.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Manual dental aspirating syringes. Materials: chrome-plated brass, stainless steel, aluminum. Reusable, non-sterile, requires sterilization. Mechanical operation for cartridge-based anesthetic delivery.

Indications for Use

Indicated for patients requiring local anesthesia via injection in the oral cavity. Used by dental professionals in conjunction with anesthetic needles and cartridges.

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

• Cartridge Syringes (Preamendment)
• Anesthetic Syringes (Preamendment)
• Anthogyr Cartridge Syringes (K040671)
• Astra Self-Aspirating Syringe (K851903)

Submission Summary (Full Text)

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Miltex
Redefining Excellence

K083796

## 510(k) Summary

589 Davies Drive
York, PA 17402

phone [phone]
toll-free 800 221-134-
fax [phone]

MAR - 9 2009

Submitted by:

Miltex. Inc. 589 Davies Drive York, PA 17402 USA

Contact Person:

Jennifer Bosley, Regulatory Affairs Manager Integra Medical Instrument Group Miltex, Inc. 589 Davies Drive York, PA 17402 USA Phone: [phone] Fax: [phone]

Date Prepared:

December 19, 2008

Device Trade Name: Common/Usual Name: Proposed Classification:

Miltex® Dental Aspirating Syringes Aspirating Syringe Syringe, Cartridge Class II, 76 EJI Dental 21 CFR 872.6770

## Device Description:

Miltex® Dental Aspirating Syringes include Standard Aspirating Syringes, Petite Aspirating Syringes, Self-Aspirating Syringe, Lightweight Self-Aspirating Syringe, Articulating Barrel Syringe and GripRite™ Standard and Petite Aspirating Syringes. All syringes are made of chrome-plated brass and stainless steel; Lightweight Self-Aspirating Syringe has aluminum handle. Syringes are reusable, sterilizable and packaged non-sterile.

### Intended Use:

Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

### Predicate Devices:

| 510(k) # | Device | Manufacturer |
|--------------|-------------------------------|-------------------------------------|
| Preamendment | Cartridge Syringes | Union Broach Co. (now Miltex, Inc.) |
| Preamendment | Anesthetic Syringes | Henke-Sass, Wolf GmbH |
| K040671 | Anthogyr Cartridge Syringes | Anthogyr |
| K851903 | Astra Self-Aspirating Syringe | Astra Pharmaceutical Products, Inc. |

#### Substantial Equivalence:

Miltex® Dental Aspirating Syringes are substantially equivalent to the legally marketed predicate devices with respect to intended use, fundamental technology, design and materials.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another figure, represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer Bosley, MBA, RAC Regulatory Affairs Manager Intergra Medical Instrument Group Miltex, Incorporated 589 Davies Drive York, Pennsylvania 17402 - :

MAR - 9 2009

Rc: K083796

> Trade/Device Name: Miltex® Dental Aspirating Syringes Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: March 2, 2009 Received: March 4, 2009

Dear Ms. Bosley:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Suiste Y. Michael Davis

Ginette Y. Michaud, M.D. Acting 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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K083796

# Indications For Use

510(k) Number (if known):

Device Name:

Miltex® Dental Aspirating Syringes

#### Indications for Use:

Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

| 510(k) Number: | K053794 |
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