EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES

K040671 · Anthogyr · EJI · Dec 14, 2004 · Dental

Device Facts

• Record ID: K040671
• Device Name: EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
• Applicant: Anthogyr
• Product Code: EJI · Dental
• Decision Date: Dec 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ANTHOGYR cartridge syringes are devices intended to inject anesthetic solutions in the oral cavity.

Device Story

Anthogyr cartridge syringes are manual dental instruments used by clinicians to deliver anesthetic solutions within the oral cavity. The product line includes intraligamental syringes (Ergoject, Miniject) designed for high-pressure applications, featuring ergonomic thermoplastic resin handles, leverage factors of 3x or 5x, and anti-reverse, non-ratcheting mechanisms to prevent plunger slippage. The range also includes aspirating (ISO 9997 Type 2a/2b) and non-aspirating (ISO 9997 Type 1) stainless steel syringes. These devices function via manual operation by the dentist or dental professional to facilitate local anesthesia administration. The mechanical design ensures controlled delivery of anesthetic, aiding in pain management during dental interventions.

Clinical Evidence

Bench testing only. The device conforms to NF EN ISO 9997 (2000) for dental cartridge syringes and ISO 13402 (1995) for resistance against autoclaving, corrosion, and thermal exposure.

Technological Characteristics

Materials include thermoplastic resin (handles) and stainless steel. Design conforms to NF EN ISO 9997 (2000) and ISO 13402 (1995). Features include manual leverage mechanisms (3x or 5x), anti-reverse non-ratcheting plungers, and various aspiration types (Type 1, 2a, 2b).

Indications for Use

Indicated for the injection of anesthetic solutions into the oral cavity for dental procedures.

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

• Miniject (Spartan Ultrasonics) (K991888)
• Aspiject (Ronvig Instruments) (K002168)
• Cartridge Syringes (Septodont Inc)
• Cartridge Syringes (Ranfac)
• Cartridge Syringes (Cook Waite Kodak)
• Cartridge Syringes (Miltex)

Submission Summary (Full Text)

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K040671

510(k) Premarket Notification ANTHOGYR CARTRIDGE SYRINGES

Image /page/0/Picture/2 description: The image shows the word "anthogyr" in a stylized font, with the "a" and "n" in a smaller font size than the rest of the word. Below the word, there are three small squares. The first square is filled with a pattern of small dots, the second square contains a drawing of a screw, and the third square is filled with a solid black color.

DEC 1 4 2004

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 1. GENERAL INFORMATION

| Submitter | ANTHOGYR (Registration number 8020776)<br>164 rue des trois lacs<br>74700 SALLANCHES FRANCE<br>Phone: [phone] Fax: [phone] |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Eric GENEVE (RD Manager) [e-mail]<br>Regulatory Affairs: Idée Consulting (Dr Isabelle DRUBAIX)<br>[e-mail] |
| Common Name | CARTRIDGE SYRINGE |
| Classification Name | CARTRIDGE SYRINGE |
| Class | II |
| Product Code | EJI |
| CFR section | 872.6770 |
| Device panel | DENTAL |

#### 2. DEVICE DESCRIPTION

ANTHOGYR has developed cartridge syringes which are substantially equivalent to legally marketed and FDA cleared predicate devices.

#### Intraligamental syringes

ERGOJECT and MINIJECT are syringes for every kind of anesthesia, especially intraligamental and intraseptal that requires high pressure. ANTHOGYR intraligamental syringes feature an ergonomic handle constructed of thermoplastic resin and have a leverage factor of three (ERGOJECT) or five (MINIJECT) to make it easier to use and an anti-reverse, non-ratcheting mechanism that prevents the plunger from slipping during injection.

#### Aspirating dental cartridge syringes

ANTHOGYR developed a full range of dental cartridge syringes including: Self aspirating syringe (ISO 9997 Type 2b - Aspiration under the effect of strength produced by the bending of a diaphragm in the cartridge), Aspirating syringe (ISO 9997 Type 2a -Aspiration under the effect of strength produced by the receding of the button in relation to the needle) and dental syringes without aspiration (ISO 9997 Type 1).

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Image /page/1/Picture/1 description: The image shows the word "anthogyr" in a stylized font above three small, square images. The first image on the left appears to be a textured or patterned square. The middle image contains a white, screw-like object on a dark background. The image on the right appears to be a dark square with some lighter elements, possibly representing a technical or scientific diagram.

#### 3. INTENDED USE

ANTHOGYR cartridge syringes are devices intended to inject anesthetic solutions in the oral cavity.

#### 4. PERFORMANCE DATA

ANTHOGYR cartridge dental syringes conform to NF EN ISO 9997 (2000) "Dental cartridge syringes" and to ISO 13402 (1995) « Surgical and dental hand instruments -Determination of resistance against autoclaving, corrosion and thermal exposure »

### 5. SUBSTANTIAL EQUIVALENCE

| ANTHOGYR Devices | Predicate devices |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Ergoject / Miniject intraligamental syringes | Miniject (Spartan Ultrasonics) K991888 |
| Self aspirating Stainless steel anesthetic<br>syringe | Aspiject (Ronvig Instruments) K002168 |
| Stainless steel and chrome plated<br>anesthetic syringes | Numerous devices currently on market<br>(Cartridge Syringes - Septodont Inc,<br>Ranfac, Cook Waite Kodak, Miltex ...) |

ANTHOGYR Devices are substantially equivalent to these predicate devices in terms of intended use, material, design and function.

Summary preparation date: February 23, 2004

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is facing to the right and has three stripes on its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

Mr. Eric Geneve Anthrogyr 164 Rue De Trois Lacs Sallanches. FRANCE. F74700

Re: K040671

Trade/Device Name: ANTHOGYR CARTRIDGE SYRINGES Regulation Number: 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: October 18, 2004 Received: October 18, 2004

Dear Mr. Geneve:

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 - Mr. Geneve

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 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/dsma/dsmamain.html

Sincerely vours.

CluLs

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

Enclosure

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K040671

510(k) Premarket Notification ANTHOGYR CARTRIDGE SYRINGES

Image /page/4/Picture/2 description: The image shows the word "anthogyr" in a stylized font, with the "a" and "y" slightly larger than the other letters. Below the word are three small, square images. The first image on the left appears to be a microscopic view of cells or tissue. The middle image shows a stylized representation of a screw or implant. The image on the right shows a celestial scene with stars and a crescent moon.

**510(k) Number (if known):** k040671

Device Name: ANTHOGYR CARTRIDGE SYRINGES

Indications for Use: ANTHOGYR cartridge syringes are devices intended to inject anesthetic solutions in the oral cavity.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

**Prescription Use**

or

## Over-the-Counter Use

(PER 21 CFR 801.109)

Susan Munro

(Optional Format 1-2-96)

.

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Antool Roomoontal Devices

510(k) Number. k040671