QUICKBRIDGE TM CYLINDER AND CAP

K071551 · Biomet 3i, Inc. · NHA · Aug 30, 2007 · Dental

Device Facts

• Record ID: K071551
• Device Name: QUICKBRIDGE TM CYLINDER AND CAP
• Applicant: Biomet 3i, Inc.
• Product Code: NHA · Dental
• Decision Date: Aug 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing.

Device Story

QuickBridge System consists of non-hexed titanium alloy cylinder and PEEK cap; used as accessory to endosseous dental implants. Titanium cylinder threads onto Biomet 3i conical abutments (4.8 mm margin diameter); PEEK cap snaps over cylinder to facilitate pickup in provisional bridge for immediate load restoration. Used in clinical dental settings by practitioners to support multiple unit prostheses during healing phase. Device provides temporary structural support for prosthetic restoration; benefits patient by enabling immediate loading during healing period.

Clinical Evidence

No clinical data. Substantial equivalence supported by design controls and verification/validation activities.

Technological Characteristics

Materials: Titanium alloy (cylinder), PEEK (cap). Design: Non-hexed cylinder threads onto 4.8 mm conical abutments; PEEK cap snaps onto cylinder. Intended for temporary use (up to 180 days).

Indications for Use

Indicated for partially or fully edentulous patients requiring multiple unit prostheses support in the mandible or maxilla during endosseous and gingival healing (up to 180 days).

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

• Certain Provide Temporary Cylinder (K061177)

Submission Summary (Full Text)

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## K07155

## BOYET 31

AUG 3 0 2007

## Summary of Safety and 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 3i, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Diana Taylor<br>Manager, Regulatory Affairs<br>Biomet 3i, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410<br>Tel. [phone]<br>Fax. [phone] |
| Date Prepared | June 5, 2007 |
| Device Name | QuickBridge™ Cylinder and Cap |
| Classification Name | Endosseous dental implant abutment |
| Device Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3630 |
| Legally Marketed Predicate Devices | Certain Provide Temporary Cylinder, K061177, 5/16/06 |
| Device Description | The QuickBridge provisional components consist of a non-<br>hexed titanium alloy cylinder and a PEEK Cap. The<br>titanium cylinder threads onto Biomet 3i Conical<br>Abutments that have a 4.8 mm margin diameter. The<br>QuickBridge Cap is made of PEEK and snaps over the<br>QuickBridge Cylinder to allow it to be picked up in a<br>provisional bridge for an immediate load restoration. |

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| Indications for Use | The QuickBridge System is intended to be mated with<br>BIOMET 3i conical abutments for use as an accessory to<br>endosseous dental implants to support a prosthetic device in<br>a partially or fully edentulous patient. The QuickBridge<br>System is intended for use to support multiple unit<br>prostheses in the mandible or maxilla for up to 180 days<br>during endosseous and gingival healing. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The design modifications for the proposed QuickBridge<br>Cylinder and Cap were completed under Quality System<br>Design Controls in accordance with 21 CFR 820.30.<br>Appropriate verification and validation activities were<br>performed to provide assurance that QuickBridge Cylinder<br>and Cap remain substantially equivalent to the predicate<br>Provide Temporary Cylinder with the Provide Abutment,<br>and the modifications have not changed the intended use,<br>altered the fundamental scientific technology or the safety<br>and effectiveness of the device. |

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diana Taylor Manager, Regulatory Affairs Biomet 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

AUG 3 0 2007

Re: K071551

Trade/Device Name: QuickBridge Cylinder and Cap Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 5, 2007 Received: June 6, 2007

Dear Ms. Taylor:

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. Taylor

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,

Supa 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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Biomet 3i, Inc. Special 510(k) Premarket Notification - QuickBridge™

## Indications for Use

510(k) Number (if known): K071551

Device Name: QuickBridge Cylinder and Cap

Indications for Use:

The QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing.

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)

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

| 510(k) Number: | K071531 |
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