DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM

K063874 · Blue Sky Bio, LLC · DZE · Mar 29, 2007 · Dental

Device Facts

• Record ID: K063874
• Device Name: DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM
• Applicant: Blue Sky Bio, LLC
• Product Code: DZE · Dental
• Decision Date: Mar 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blue Sky Bio Dental Implant System is intended for use in either partially or fully edentulous mandibles and maxillae to give support to single or multiple units fixed dental prosthesis. It is also intended to give support to overdentures by means of o-ring abutments or bar-attachments. The system is suitable for a one-stage and two-stage protocol. Immediate placement and loading is indicated following certain restrictions. The Blue Sky Bio Drills are intended to make ostotomies in the mandible or maxilla to accept dental implants.

Device Story

Blue Sky Bio Dental Implant System consists of endosseous dental implants and surgical drills; used by dental professionals in clinical settings for tooth replacement. Implants placed into maxilla or mandible to support fixed/removable prostheses or overdentures. System supports one-stage or two-stage surgical protocols; allows immediate placement and loading under specific stability criteria. Drills create osteotomies for implant site preparation. Device provides structural foundation for dental restoration; improves patient masticatory function and aesthetics.

Clinical Evidence

Bench testing only.

Technological Characteristics

Endosseous dental implants and surgical drills. System supports one-stage and two-stage surgical protocols. Implants supplied sterile or non-sterile. No specific materials or software algorithms described.

Indications for Use

Indicated for patients with partially or fully edentulous maxilla or mandible requiring support for single or multiple unit fixed or removable dental prostheses. Includes immediate placement and loading protocols under specific stability and bone quality conditions (Type I/II bone).

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Submission Summary (Full Text)

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K063874

Blue Sky Bio, LLC

888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: [phone] Fax: [phone] Email: [e-mail]

# 510(K) Summary

## General Information

MAR 2 9 2007

| Classification Name: | Endosseous Implant |
|----------------------|------------------------------------|
| Common Name: | Prosthetic Dental Implant System |
| Trade Name: | Blue Sky Bio Dental Implant System |
| Submitter's Name: | Blue Sky Bio, LLC |
| Address: | 888 E Belvidere Rd., Suite 212 |
| | Grayslake, IL 60030 |
| Telephone: | 847-548 8499 |
| Fax: | 847-548 8491 |
| Contact: | Michele Vovolka |
| Date of Summary | December 2006 |

## Device Description

The modification of the Blue Sky Bio Dental Implant System consists of two new surfaces. An implant length of 8mm is introduced. Modifications to the existing system do not introduce new issues of safety or efficacy. The implants and components are supplied sterile or not sterile and are labeled accordingly.

#### Intended Use

The Blue Sky Bio Dental Implant System is intended for use in either partially or fully edentulous mandibles and maxillae to give support to single or multiple units fixed dental prosthesis. It is also intended to give support to overdentures by means of o-ring abutments or bar-attachments. The system is suitable for a one-stage and two-stage protocol. Immediate placement and loading is indicated following certain restrictions.

The Blue Sky Bio Drills are intended to make ostotomies in the mandible or maxilla to accept dental implants.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michele Vovolka Blue Sky Bio, LLC 888 E Belvidere Road, Suite 212 Grayslake, Illinois 60030

MAR 2 9 2007

Re: K063874

Trade/Device Name: Blue Sky Bio Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 28, 2006 Received: December 29, 2006

Dear Ms. Vovolka:

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. Vovolka

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.

Soufte y. Michael Dmd.

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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Blue Sky Bio, LLC

888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: [phone] Fax: [phone] Email: [e-mail]

## Indications for Use Statement

510(k) Number (if Known):_____________________________________________________________________________________________________________________________________________________

Device Name: Blue Sky Bio Dental Implant System

Indications for Use:

- . For implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
- . For implantation into any area of the partially edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
- . For single tooth or multiple unit prosthesis
- . For single stage or two stage surgical procedure
- One piece implants for single stage procedure only .
- For immediate placement and immediate function when multiple units are splinted and for single . units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.

Prescription Use
(21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

Kein Mulvey for MSR

nesthesiology,

510(k) Number: K063874

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December 2006

Blue Sky Bio, LLC 510(k)

Blue Sky Bio, LLC 510(k)

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