CAM STRUCTSURE PRECISION MILLED BARS

K080864 · Biomet 3i, Inc. · NHA · Jul 21, 2008 · Dental

Device Facts

• Record ID: K080864
• Device Name: CAM STRUCTSURE PRECISION MILLED BARS
• Applicant: Biomet 3i, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

Device Story

CAM StructSURE® Precision Milled Bars are patient-specific dental abutments used to support screw-retained prostheses. Input data consists of 3D optical or digital scans of patient impressions. CAD/CAM software processes these scans to design the bar, which is then machined from titanium alloy or CP titanium. The device is used in a clinical setting by dental professionals to support multiple tooth prostheses in the mandible or maxilla. The output is a custom-milled bar that integrates with endosseous dental implants, providing a stable foundation for prosthetic teeth, thereby restoring function and aesthetics for the patient.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Titanium alloy or CP titanium. Sensing/Actuation: CAD/CAM-based design from 3D optical/digital scans. Form factor: Patient-specific milled bars (Dolder, Primary, Hader, Hybrid, Copy Milled). Connectivity: N/A. Sterilization: Not specified. Software: CAD/CAM system for design and machining.

Indications for Use

Indicated for partially or edentulous patients requiring support for multiple tooth prostheses in the mandible or maxilla via endosseous dental implants.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• 3i Patient Specific Overdenture Bars (K034035)

Submission Summary (Full Text)

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K080864

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JUL 2 1 2008

## Summary of Safety & Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

| Submitter: | BIOMET <i>3i</i><br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 1038806 |
| Contact: | Tamara J. West<br>International Regulatory Affairs Manager<br>BIOMET <i>3i</i><br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>Tel. [phone]<br>Fax. [phone]<br>Email <a href="mailto:[e-mail]">[e-mail]</a> |
| Date Prepared: | March 27, 2008 |
| Trade/Proprietary Name: | CAM StructSURE® Precision Milled Bars |
| Common/Usual Name: | Overdenture Bar |
| Classification Name: | Endosseous dental implant abutment<br>21 CFR § 872.3630 |
| Device Classification: | Class II<br>Dental Devices Panel |
| Legally Marketed Predicate<br>Devices: | K034035 3i Patient Specific Overdenture Bars |

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| Device Description: | All CAM StructSURE® Precision Milled Bars (Dolder,<br>Primary, Hader, Hybrid and Copy Milled) are designed<br>to match an individual patient. The bars are designed<br>from a three-dimensional optical and/or digital scanner<br>system that scans the casting of a patient's impression<br>and then is machined using a CADCAM software<br>system. The bars are milled from titanium alloy or CP<br>titanium.<br><br>CAM StructSURE® Precision Milled Bars:<br>CSHxx CAM StructSURE Hader Bar:<br>2-10 implants CSPxx CAM StructSURE Primary Bar:<br>2-10 implants CSDxx CAM StructSURE Dolder Bar:<br>2-10 implants CSCMxx CAM StructSURE Copy Milled Bar:<br>4-10 implants CSIYxx CAM StructSURE Hybrid Bar:<br>4-10 implants |
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| Indications for Use: | The CAM StructSURE® Precision Milled Bars are<br>intended for use as an accessory to an endosseous dental<br>implant to support a prosthetic device in a partially or<br>edentulous patient. It is intended for use to support<br>multiple tooth prostheses in the mandible or maxilla.<br>The prostheses can be screw retained. |
| Conclusion: | The proposed design modifications for the CAM<br>StructSURE® Precision Milled Bars were completed<br>under Quality System Design Controls in accordance<br>with 21 CFR 820.30.<br><br>Appropriate verification and validation activities were<br>performed to provide assurance that CAM<br>StructSURE® Precision Milled Bars remain<br>substantially equivalent to the predicate and the<br>modifications have not changed the intended use,<br>altered the fundamental scientific technology or the<br>safety and effectiveness of the device. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 1 2008

Ms. Tamara West International Regulatory Affairs Manager BIOMET, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K080864

Trade/Device Name: CAM StructSURE® Precision Milled Bars Regulation Number: 872.3636 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 6, 2008 Received: May 19, 2008

Dear Ms. West:

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 - Ms. West

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Susan Rimmer
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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Image /page/4/Figure/1 description: The image shows the logo for BIOMET 3i. The logo is in black and white and features a stylized font. The words "BIOMET" and "3i" are clearly visible in the logo. The logo appears to be for a medical or dental company.

## Indications for Use

510(k) Number (if known): K089 864

Device Name: CAM StructSURE® Precision Milled Bars

Indications for Use:

The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susel Rumm

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

510(k) Number: K080864

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