ERCH ARCH BAR, MODEL 38-690-00

K061271 · KLS-Martin L.P. · DYX · Jun 30, 2006 · Dental

Device Facts

• Record ID: K061271
• Device Name: ERCH ARCH BAR, MODEL 38-690-00
• Applicant: KLS-Martin L.P.
• Product Code: DYX · Dental
• Decision Date: Jun 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandibular fixation.

Device Story

The Erich Arch Bar is a stainless steel device used for temporary jaw immobilization. It is installed by an oral surgeon or dentist who affixes the bar to the patient's teeth using ligature wire. The device provides mechanical stabilization for intermaxillary and maxillomandibular fixation. It is used in a clinical setting to assist in the management of jaw alignment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed from fully annealed electro-polished 304 stainless steel. Mechanical device for intraoral fixation. No energy source, software, or connectivity.

Indications for Use

Indicated for intermaxillary and maxillomandibular fixation in patients requiring temporary jaw immobilization.

Regulatory Classification

Identification

An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.

Predicate Devices

• Safety Release Arch Bar Kit (K031207)
• Wire Aragon Wiring System Cartridge (K022821)
• Synthes Quick Lock IMF System (K991004)
• Dental Arch Bar (K820944)

Submission Summary (Full Text)

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K061271

# 510(K) SUMMARY

JUN 3 0 2006

| Submitter: | KLS-Martin, L.P.<br>11239-1 St. Johns Industrial Parkway South<br>Jacksonville, FL 32246<br>Phone: [phone]<br>Fax: [phone] |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato<br>Director RA/QA |
| Date of Summary: | 24 March 2006 |

Device Name:

Trade Name:

Common Name:

Classification Name and Number:

Regulatory Class:

Predicate Devices:

Intended Use:

Device Description: Erich Arch Bar

Erich Arch Bar

Arch bar

Lock, Wire, and Ligature, Intraoral (CFR 872.4600)

ll

Safety Release Arch Bar Kit (K031207)

Wire Aragon Wiring System Cartridge (K022821)

Synthes Quick Lock IMF System (K991004)

Dental Arch Bar (K820944)

The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandibular fixation.

The Erich Arch Bar is made of fully annealed electro polished stainless steel which is affixed temporarily to the teeth by an oral surgeon or dentist with ligature wire. The installed device provides temporary jaw immobilization.

... .

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## Technological Characteristics:

#### Similarities to Predicate

The Erich Arch Bar is identical in application and indications for use as the Safety Release Arch Bar Kit (K031207), Synthes Quick Lock IMF System (K991004) and the Dental Arch Bar (K820944).

### Differences to Predicate

The Erich Arch Bar is manufactured from 304 stainless steel and the Synthes Quick Lock IMF System (K991004) is manufactured from 316L stainless steel.

### Substantial Equivalence:

The Erich Arch Bar is substantially equivalent in indications for use, material composition and application to the Safety Release Arch Bar Kit (K031207), Aragon Wiring System Wire Cartridge (K022821), Synthes Quick Lock IMF System (K991004) and the Dental Arch Bar (K820944).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

JUN 3 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer Damato Director, Regulatory Affairs & Quality Assurance KLS-Martin, L.P. 11239-1 Saint John's Industrial Parkway South Jacksonville, Florida 32246

Re: K061271

Trade/Device Name: Erich Arch Bar Regulation Number: 872.4600 Regulation Name: Intraoral Ligature and Wire Lock Regulatory Class: II Product Code: DYX Dated: April 21, 2006 Received: May 5, 2006

Dear Ms. Damato:

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 vour device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning vour 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 (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 vour device to proceed to the market.

If vou 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 vours.

Susan Knorr

Ex, 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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## Indications for Use

510(k) Number (if known):

Device Name: Erich Arch Bar

Indications For Use:

The Erich Arch Bar is indicated for use in intermaxillary and maxillomandibular fixation.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suver Runare

of Anesthesiology, General Hospital Control, Dental Devices

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