BLUE SKY BIO DENTAL IMPLANT SYSTEM

K073713 · Blue Sky Bio, LLC · DZE · Mar 28, 2008 · Dental

Device Facts

• Record ID: K073713
• Device Name: BLUE SKY BIO DENTAL IMPLANT SYSTEM
• Applicant: Blue Sky Bio, LLC
• Product Code: DZE · Dental
• Decision Date: Mar 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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 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. Abutments are intended for use in conjunction with compatible Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restoration.

Device Story

Blue Sky Bio Dental Implant System consists of endosseous dental implants and prosthetic abutments. Modification introduces angled abutments, custom-milled abutments for off-axis placement, UCLA-type straight abutments, 8mm length implants, and ceramic surgical osteotomy drills. Used by dental clinicians in clinical settings for surgical placement into maxilla or mandible. Implants provide structural foundation for fixed or removable dental prostheses. Abutments connect implant to restoration. System supports single-stage or two-stage surgical procedures; immediate function possible with adequate bone stability. Benefits include restoration of dental function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implants and abutments. Includes ceramic surgical osteotomy drills. Materials and design consistent with standard dental implant systems. Intended for surgical implantation into alveolar bone.

Indications for Use

Indicated for patients requiring dental prostheses in fully or partially edentulous maxilla and mandible. Supports single or multiple-unit restorations, including immediate placement/function under specific stability and loading conditions. No specific age or gender contraindications provided.

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)

{0}------------------------------------------------

Blue Sky Bio, LLC

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

# 510(K) Summary

## General Information

| 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<br>Grayslake, IL 60030 |
| Telephone: | 847-548 8499 |
| Fax: | 847-548 8491 |
| Contact: | Michele Vovolka |
| Date of Summary | November 2007 |

## Device Description

The modification of the Blue Sky Bio Dental Implant System consists of angled abutments and abutments to be custom milled to a specific angle to allow restoration of implants which are placed at an off-axis. A line of UCLA type straight abutments is introduced. In addition, an implant with a length of 8mm is introduced. A ceramic surgical osteotomy drill is also introduced.

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
- 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.
- Abutments are intended for use in conjunction with compatible Implant System in partially or . fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restoration.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is composed of three thick, curved lines that suggest feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAR 2 8 2008

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

Re: K073713

Trade/Device Name: Blue Sky Bio Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 29, 2006 Received: December 31, 2007

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.

{2}------------------------------------------------

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 vour 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,

Sattie Y. Michie Ons.

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

{3}------------------------------------------------

#### Indications for Use Statement

Page 1_of _1_

K073713 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
- 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.
- Abutments are intended for use in conjunction with compatible Implant System in partially or . fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restoration.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Division Sign Off

ision Sign-Off Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073713

Prescription Use ਮ (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Blue Sky Bio, LLC 510(k)

Blue Sky Bio, LLC 510(k)

Page 10-Proprietary & Confidential

December 2007