SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW

K073342 · Salvin Dental Specialties, Inc. · DZL · Mar 26, 2008 · Dental

Device Facts

• Record ID: K073342
• Device Name: SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
• Applicant: Salvin Dental Specialties, Inc.
• Product Code: DZL · Dental
• Decision Date: Mar 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Salvin Dental Specialties, Inc. Titanium Fixation Screw is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction. Single patient use only.

Device Story

The Salvin Dental Specialties Titanium Fixation Screw System consists of 1.5mm and 2.0mm diameter titanium (Ti-6Al-4V) bone screws in lengths ranging from 4mm to 15mm. The 2.0mm screws are designated as emergency screws. The devices are provided non-sterile for single-patient use. They are used by clinicians for the internal fixation of small bones in the craniofacial and maxillofacial skeleton following trauma or during reconstructive procedures. The screws provide mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V). Dimensions: 1.5mm and 2.0mm diameters; 4, 6, 8, 10, 13, and 15mm lengths. Mechanical testing performed per ASTM F 543-02. Non-sterile.

Indications for Use

Indicated for internal fixation of small bones in the craniofacial and maxillofacial skeleton for trauma or reconstruction. For prescription use only.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Osteomed Auto-Drive Screw System (K023260)
• Leibinger Self-Drilling Screw (K970912)
• Integra Bone Fixation System (K050492)
• Integra Bone Fixation System (K040860)

Submission Summary (Full Text)

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K073342

Image /page/0/Picture/1 description: The image shows the logo for "SALVIN Dental Specialties". The word "SALVIN" is in large, bold, black letters at the top of the logo. Below "SALVIN" is the phrase "Dental Specialties" in a smaller font, also in black. The registered trademark symbol is to the right of the word "SALVIN".

MAR 2 6 2008

## Salvin Dental Specialties, Inc 3450 Latrobe Drive • Charlotte, NC 28211 • Phone [phone] • Fax [phone]

## 510(k) Summary

| A | 510(k) Owner | Salvin Dental Specialties, Inc<br>3450 Latrobe Drive<br>Charlotte, NC 28211 |
|---|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact | Robert Salvin<br>CEO<br>Salvin Dental Specialties, Inc.<br>3450 Latrobe Drive<br>Charlotte, NC 28211<br>[phone]<br>[phone]<br>[e-mail] |
| | Preparation Date | November 23, 2007 |
| B | Trade Name | Salvin Dental Specialties, Inc. Titanium Fixation Screw<br>System |
| | Common Name | Fixation Screw |
| | Classification Name | Screw, Fixation, Bone<br>(21 CFR 888.3040, Product code HWC) |
| C | Predicate Device(s) | K023260 – Osteomed Auto-Drive Screw System<br>K970912 - Leibinger Self-Drilling Screw<br>K050492 - Integra Bone Fixation System<br>K040860 - Integra Bone Fixation System |
| D | Device Description | The Salvin Dental Specialties Titanium Fixation Screw<br>System consists of 1.5mm and 2.0mm Titanium (Ti-6Al-<br>4V) bone screws in lengths of 4, 6, 8, 10, 13 and 15mm. |
| | | The 2.0mm diameter screws are “emergency” screws. |
| | | The devices are provided non-sterile. |
| E | Intended Use | The Salvin Dental Specialties, Inc. Titanium Fixation<br>Screw is intended for use in internal fixation of small<br>bones including the craniofacial and maxillofacial<br>skeleton affected by trauma, or for reconstruction.<br><br>Single patient use only. |
| F | Technological<br>Characteristics | As was established in this submission, the subject device<br>is substantially equivalent to other devices cleared by the<br>agency for commercial distribution in the United States.<br><br>Engineering drawings, labeling, and mechanical testing<br>have demonstrated that the subject device is substantially<br>equivalent, if not identical, to its predicate devices in<br>terms of design, materials of composition, indications for<br>use, and such other characteristics as may be associated<br>with the manufacture of any medical device. |

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- ASTM F 543-02 Standard Specification and Test Non-Clinical Testing G Methods for Metallic Medical Bone Screws
- Not applicable to this device Clinical Testing H
- Based on the 510(k) Summary and the information Conclusions I provided herein, we conclude that the Salvin Dental Specialties Titanium Fixation Screw is substantially equivalent to the existing legally marketed devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 6 2008

Mr. Robert Salvin Chief Executive Officer Salvin Dental Specialties, Incorporated 3450 Latrobe Drive Charlotte, North Carolina 28211

Re: K073342

Trade/Device Name: Salvin Dental Specialties Fixation Screw Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: March 13, 2008 Received: March 14, 2008

Dear Mr. Salvin:

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 your device in the Federal Register.

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Page 2 - Mr. Salvin

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 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/industry/support/index.html.

Sincerely yours,

Sutte y. Michie Omd

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: Salvin Dental Specialties Fixation Screw

Indications for Use:

The device is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction.

Single patient use only

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

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Rsi. Betz DDS for Dr. S. Ruminia

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

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510(k) Number: K173342