MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM

K060957 · Blue Sky Bio, LLC · DZE · May 5, 2006 · Dental

Device Facts

• Record ID: K060957
• Device Name: MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
• Applicant: Blue Sky Bio, LLC
• Product Code: DZE · Dental
• Decision Date: May 5, 2006
• Decision: SESE
• Submission Type: Special
• 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 partify of fixed dental prosthesis. It is also intended to give support to overdentures by means of o-ring abutments or bar-attachmont. The system is suitable for a one-stage and two-stage protocol. Immediate placement and hoaling is indicated following certain restrictions.

Device Story

Root form dental implants and associated abutment systems; used for prosthetic restoration in edentulous or partially edentulous patients. Implants surgically placed into maxilla or mandible by dental clinicians. System supports single-tooth, multiple-unit, or overdenture prostheses via cement-retained or bar/o-ring attachments. Supports one-stage or two-stage surgical protocols; allows immediate placement/loading under specific stability and bone quality conditions. Provides structural foundation for dental prosthetics; improves patient masticatory function and aesthetics.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, intended use, and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Root form endosseous dental implants and abutments. Materials and specifications not detailed. System supports one-stage and two-stage surgical protocols. Components supplied sterile or non-sterile.

Indications for Use

Indicated for partially or fully edentulous maxilla and mandible patients requiring support for single, multiple, or full-arch fixed or removable dental prostheses. Suitable for one-stage or two-stage surgical procedures. Immediate placement and function permitted for splinted multiple units or single units with adequate initial stability in Type I or II bone under appropriate occlusal loading.

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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Blue Sky Bio, LLC

K060957

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

MAY - 5 2005

## 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 | May 2005 |

### Device Description

The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the cliniaian with cement retained and overdenture-type restorative options. 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 partify of fixed dental prosthesis. It is also intended to give support to overdentures by means of o-ring abutments or bar-attachmont. The system is suitable for a one-stage and two-stage protocol. Immediate placement and hoaling is indicated following certain restrictions.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2005

Dr. Albert Zickmann Blue Sky Bio, LLC 888 East Belvidere, Suite 212 Grayslake, Illinois 60030

Re: K060957

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: March 29, 2006 Received: April 7, 2006

Dear Dr. Zickmann:

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 tarson. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Dr. Zickmann

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,

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

# Indications for Use Statement

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510(k) Number (if Known):_K060957

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Anesthesiology, General Hospital,

Control, Dental Devices

| Prescription Use | <span style="text-decoration: overline;">✓</span> |
|----------------------|---------------------------------------------------|
| (Per 21 CFR 801.109) | |

| | K060957 | |
|--|---------|--|
|--|---------|--|

| | <i>OR</i> | |
|--|-----------|--|
|--|-----------|--|

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

Blue Sky Bio, LLC 510(k)

Blue Sky Bio, LLC 510(k) Page 8 March 2006

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