MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM

K021833 · Blue Sky Bio · DZE · Jun 10, 2002 · Dental

Device Facts

• Record ID: K021833
• Device Name: MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
• Applicant: Blue Sky Bio
• Product Code: DZE · Dental
• Decision Date: Jun 10, 2002
• 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 units fixed dental prosthesis. It is also intended to give support to overdentures by means of o-ring abutments or bar-attachments.

Device Story

Blue Sky Bio Dental Implant System consists of root form dental implants and associated abutment systems; used for prosthetic restoration in edentulous or partially edentulous patients. Implants are surgically placed in maxilla or mandible by clinicians; supports single/multiple unit fixed prostheses or overdentures via o-ring/bar attachments. System supports one-stage or two-stage surgical protocols; not intended for immediate loading. Clinicians use device to restore oral function and aesthetics for patients requiring tooth replacement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Root form dental implants and abutment systems. Supplied sterile or non-sterile. Supports one-stage and two-stage surgical protocols. Materials and specific standards not detailed in provided text.

Indications for Use

Indicated for implantation into fully or partially edentulous maxilla and mandible to support single or multiple unit fixed or removable dental prostheses.

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}------------------------------------------------

# JUN 1 0 2002

K021833

5455 N Sheridan Road, #3608 Chicago, IL 60640 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 | | |
| Address: | 5455 N Sheridan Road, #3608<br>Chicago, IL 60640 | | |
| Telephone: | 773-769 2622 | | |
| Fax: | 773-878 8884 | | |
| Contact: | Dr. Albert Zickmann | | |
| Date of Summary | May 2002 | | |

#### 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 clinician 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. The system is suitable for a one-stage and two-stage protocol. The Implant system is not intended for immediate loading.

### 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.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head in profile, facing left, with three curved lines representing the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2002

Dr. Albert Zickmann Blue Sky Bio 5455 N. Sheridan Road, # 3608 Chicago, Illinois 60640

Re: K021833

Trade/Device Name: Blue Sky Bio Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE and NHA Dated: May 20, 2002 Received: June 4, 2002

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 vour 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.

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.

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

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours

Tim A. Ulatowski

Timo Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

#### Dr. Albert Zickmann

5455 N Shericlan Road, #3608 Chicago, IL 60640 Tel: [phone] Fax: [phone] Email: [e-mail]

#### Indications for Use Statement

Page _ 1_ of _ 1_

# 510(k) Number (if Known): KO2 |833

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 .

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|----------|--------------------------------------------------------|
| (Divis | |
| Divis; | - Stontrol, |
| and G | |
| 510(k) : | K021833 |

| Prescription Use | <div> <span style="text-decoration: underline;">✓</span> </div> | OR | Over-The-Counter Use |
|----------------------|-----------------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

| Dr. Zickmann 510(k) | Page 10<br>Proprietary & Confidential | May 20, 2002 |
|---------------------|---------------------------------------|--------------|
|---------------------|---------------------------------------|--------------|