KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR

K983809 · KLS-Martin L.P. · MQN · Jan 26, 1999 · Dental

Device Facts

• Record ID: K983809
• Device Name: KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
• Applicant: KLS-Martin L.P.
• Product Code: MQN · Dental
• Decision Date: Jan 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An uni-directional, intra-oral device for the distraction of the ascending ramus and mandibular body.

Device Story

The KLS-Martin Intraoral Zurich Ramus Distractor is an intra-oral, uni-directional device used for mandibular distraction osteogenesis. It is designed to address mandibular deficiency or posttraumatic mandibular conditions. The device is surgically implanted to facilitate the gradual lengthening of the ascending ramus and mandibular body. It is intended for use by clinicians in a surgical setting. By providing controlled distraction, the device assists in bone regeneration and structural correction of the mandible, potentially improving patient functional and aesthetic outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intra-oral, uni-directional distraction device. Materials and specific standards are not detailed in the provided text. The device is a mechanical surgical implant.

Indications for Use

Indicated for patients requiring distraction of the ascending ramus and mandibular body for correction of mandibular deficiency or posttraumatic effects.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• KLS-Martin Intraoral Horizontal Distractor

Submission Summary (Full Text)

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JAN 26 1999

Kag3809

## 510(K) SUMMARY (as required by 807.92(c))

Submitter of 510(k):

Regulatory & Marketing Services, Inc. (RMS) 3234 Ella Lane . New Port Richey, FL 34655

Phone: [phone] Fax: [phone]

Ed Ransom or Pat Lamb

October 28, 1998

Contact Person:

Trade Name:

Date of Summary:

KLS-Martin Intraoral Zurich Ramus Distractor

Classification Name:

Predicate Device:

Device Description Comparison:

"

Ridgid External Distractor

KLS-Martin Intraoral Horizontal Distractor

The KLS-Martin distractor device is designed to distract the mandible in cases of deficiency or posttraumatic effects of the mandible.

Intended Use:

An uni-directional, intra oral device for the distraction of the ascending ramus and mandibular body.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR - 8 2001

KLS-Martin L.P. C/O Mr. Arthur J. Ward Regulatory & Marketing Services, Incorporated (RMS) 3234 Ella Lane New Port Richey, Florida 34655

Re: K983809 KLS Martin Intraoral Zurich Ramus Trade Name: Distractor Requlatory Class: II Product Code: MON December 8, 2000 Dated: December 12, 2000 Received:

Dear Mr. Ransom:

This letter corrects our substantially equivalent letter of December 8, 2000 regarding the Trade Name.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent [{for the indications for use stated in the enclosure)] to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval) it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. તે substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in Please note: this response to your the Federal Register.

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Page 2 - Mr. Ward

premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 that the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Intra-oral Mandibular Distractor

Indications For Use:

An uni-directional, intra-oral device for the distraction of the ascending ramus and mandibular body.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Over-The-Counter Use

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Division of Hospital Devices

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Division of Dental, Infection Control,

(Division Sign-Off)

510(k) Number _

(Optional Format 1-2-96)

1 AM

Prescription Use_ (Per 21 CFR 801.109)

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