KLS INTRAORAL VERTICAL DISTRACTOR

K983515 · KLS-Martin L.P. · MQN · Nov 30, 1998 · Dental

Device Facts

• Record ID: K983515
• Device Name: KLS INTRAORAL VERTICAL DISTRACTOR
• Applicant: KLS-Martin L.P.
• Product Code: MQN · Dental
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KLS-Martin intra-oral distractor is intended to be used in the conditions of mandibular deficiency or post-traumatic effects of the mandible.

Device Story

Intra-oral Mandibular Distractor is a mechanical device used to distract the mandible. It is indicated for patients suffering from mandibular deficiency or post-traumatic effects. The device is surgically implanted to facilitate bone distraction, aiding in the correction of mandibular structural issues. It is intended for prescription use by clinicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical mandibular distraction device. Materials and specific technical standards are not detailed in the provided documentation.

Indications for Use

Indicated for patients with mandibular deficiency or post-traumatic mandibular 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 Distractor (K973275)

Submission Summary (Full Text)

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NOV 3 0 1998

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K983515

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

| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)<br>3234 Ella Lane<br>New Port Richey, FL 34655 | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| | Phone:<br>Fax: | 813-376-4154<br>813-376-7186 |
| Contact Person: | Ed Ransom or Pat Lamb | |
| Date of Summary: | October 7,1998 | |
| Trade Name: | Intra-oral Mandibular Distractor | |
| Classification Name: | Rigid External Distractor | |
| Predicate Device: | KLS Distractor K973275 | |
| Device Description/<br>Comparison: | The KLS Martin Distractor device is designed to<br>distract the mandible in cases of deficiency or post-<br>traumatic effects of the mandible. | |
| Intended Use: | The KLS-Martin intra-oral distractor is intended to be<br>used in the conditions of mandibular deficiency or<br>post-traumatic effects of the mandible. | |

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Image /page/1/Picture/2 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 top half of the circle. In the center of the seal is an abstract image of an eagle.

NOV 3 0 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KLS-Martin L.P. C/O Mr. Ed Ransom Regulatory & Marketing Services, Incorporated (RMS) 3234 Ella Lane New Port Richey, Florida 34652

Re : K983515 KLS Intra-oral Vertical Distractor Trade Name: Regulatory Class: II Product Code: MQN October 6, 1998 Dated: October 7, 1998 Received:

Dear Mr. Ransom:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531

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Page 2 - Mr. Ransom

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.qov/cdrh/dsma/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): ____________________________________________________________________________________________________________________________________________________ Unknown

Intra-oral Mandibular Distractor Device Name:

The KLS-Martin Intro-oral Distractor is intended to be used Indications For Use: in the conditions of mandibular deficieincy or post-traumatic effects of the mandible.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

**Prescription Use**
(Per 21 CFR 801.109)

✓

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Over-The-Counter Use

Heavid W. Shipp
(Division Sign-Off)

Division of Dental, Infection Control, (Optional Format 1-2-96) and General Hospital Devices 510(k) Number _ 15835