BLUE SKY BIO DENTAL IMPLANT SYSTEM

K102034 · Blue Sky Bio, LLC · DZE · Apr 19, 2011 · Dental

Device Facts

• Record ID: K102034
• Device Name: BLUE SKY BIO DENTAL IMPLANT SYSTEM
• Applicant: Blue Sky Bio, LLC
• Product Code: DZE · Dental
• Decision Date: Apr 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Two-Piece Implant Systems: For implantation into any area of the fully 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. Unsplinted narrow implants and angled abutments are not to be used in the posterior areas. Taper Hex Implant System is compatible with NobelActive implants and prosthetics. Double Hex Implant System is compatible with Astra double hex implants and prosthetics. Square Taper Implant System is compatible with Straumann Bone-Level implants and prosthetics. For One-Piece Implant System: For implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis. For single tooth or multiple unit prosthesis. For single 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. In edentulous cases four or more implants must be used. Overdenture Implants are intended for support of removable prosthesis.

Device Story

Root form dental implants and abutments; Ti-6Al-4V titanium alloy; internal anti-rotational geometry or one-piece design. Surface treated via blasting and acid etching (activFluor) to enhance bone apposition. Used by clinicians in dental procedures for single/two-stage surgery; immediate placement/function possible under specific stability/loading conditions. Includes laboratory analogs and drivers. Output is a structural foundation for dental prostheses. Compatibility with NobelActive, Astra, and Straumann systems provided via specific implant/abutment interfaces.

Clinical Evidence

Bench testing only. Compatibility testing performed per FDA guidance for root-form endosseous dental implants. Fatigue testing conducted per ISO 14801; results confirm subject devices have larger wall thickness and equivalent or superior strength compared to predicates.

Technological Characteristics

Material: Ti-6Al-4V titanium alloy. Surface: Blasted (resorbable medium or aluminum oxide) and acid-etched. Design: Root form, internal hex/square/tapered anti-rotational geometries or one-piece. Sterilization: Gamma. Connectivity: Mechanical interface compatible with NobelActive, Astra, and Straumann systems.

Indications for Use

Indicated for patients requiring dental prostheses in fully edentulous maxilla or mandible. Supports single or multiple unit, fixed or removable prostheses. Contraindicated for unsplinted narrow implants and angled abutments in posterior areas.

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.

Predicate Devices

• Blue Sky Bio Dental Implant Systems (K051507, K060957, K063874, K073713)
• Nobel Biocare Dental Implant System (K071370)
• Zimmer Dental Implant System (K052997)
• Straumann Dental Implant System (K062129)

Submission Summary (Full Text)

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Blue Sky Bio, LLC

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Image /page/0/Picture/1 description: The image shows an address and contact information. The address is 888 E BELVIDERE, SUITE 212, GRAYSLAKE, IL 60030. The phone number is 718-376 0422, and the fax number is 888-234 3685.

# 510(K) Summary

APR 1 9 2011

| General Information | |
|----------------------|-------------------------------------------------------|
| Classification Name: | Endosseous Implant |
| Common Name: | Prosthetic Dental Implant System |
| Product Code | DZE |
| 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 | June 2010 |

# 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 , screw retained and overdenture-type restorative options. The implants and abutments are made out of Ti6Al4V titanium alloy and have an internal anti-rotational geometry or have a one-piece design with the abutment portion being an integral part of the implant. The device also includes exempt accessories such as laboratory analogs and drivers for insertion of the implants. and The activFluor surface treatment of the implants is the same as on Blue Sky Bio's predicate devices and is performed by blasting the surface and chemically etching to enhance the surface roughness for apposition of bone to the implant surface. The implants and components are supplied sterile or not sterile and are labeled accordingly.

### Device Description Chart

| Abutment Type | Platform | Angle deg. | Blue Sky Bio Predicate |
|---------------------|-----------------------|------------|------------------------|
| Square Taper Angled | Regular, Wide | 15 | K073713 |
| Square Taper Angled | Regular, Wide | 25 | K073713 |
| Double Hex Angled | Narrow, Regular, Wide | 15 | K073713 |
| Double Hex Angled | Narrow, Regular, Wide | 25 | K073713 |
| Taper Hex Angled | Narrow, Regular, Wide | 15 | K073713 |
| Taper Hex Angled | Narrow, Regular, Wide | 30 | K073713 |

| Titanium alloy straight abutments | Platform | Predicate |
|-----------------------------------|-----------------------|-------------------|
| Square Taper | Regular, Wide | K051507 , K060957 |
| Double Hex | Narrow, Regular, Wide | K051507 , K060957 |
| Taper Hex | Narrow, Regular, Wide | K051507 , K060957 |

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### Attachment 2

888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: [phone] Fax: [phone]

UCLA Abutments Square Taper UCLA straight Double Hex UCLA straight Taper Hex UCLA straight

Platform Regular, Wide Narrow, Regular, Wide Narrow, Regular, Wide

BSB Predicate K051507 , K060957 K051507 , K060957 K051507 , K060957

| Implant style | Diameter<br>mm | Length | Blue Sky Bio<br>Predicate | Predicate Size<br>Range |
|----------------------------------|----------------|-----------------------|---------------------------|---------------------------------|
| Square Taper | 3.3 | 8, 10, 12, 14, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Square Taper | 3.3 | 8, 10, 12, 14, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Square Taper | 4.1 | 8, 10, 12, 14, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Square Taper | 4.8 | 8, 10, 12, 14, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Square Taper | 5.6 | 8, 10, 12, 14, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Square Taper | 7.0 | 8, 10, 12, 14, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Square Taper | 8.0 | 8, 10, 12, 14, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Double Hex | 3.25 | 9, 11, 13, 15, 17mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Double Hex | 3.5 | 9, 11, 13, 15, 17mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Double Hex | 4.0 | 9, 11, 13, 15, 17mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Double Hex | 5.0 | 9, 11, 13, 15, 17mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Taper Hex | 3.3 | 8, 10, 11.5, 13, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Taper Hex | 4.3 | 8, 10, 11.5, 13, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Taper Hex | 5.0 | 8, 10, 11.5, 13, 16mm | K 051507, K060957 | Ø 3.3mm-6mm;<br>Length 8-16mm |
| Internal Hex | 3.25 | 10, 11.5, 13, 16mm | K 051507, K060957 | Ø 3.3mm-4.8mm;<br>Length 8-16mm |
| One Piece Implant | 3.0 | 10, 12, 14mm | K051507 | Ø 3.3mm-4.8mm;<br>Length 8-16mm |
| One Piece Implant<br>Overdenture | 3.0 | 10, 12, 14mm | K051507 | Ø 3.3mm-4.8mm;<br>Length 8-16mm |

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| Blue Sky Bio, LLC | | 888 E BELVIDERE<br>SUITE 212<br>GRAYSLAKE, IL 60030<br>Tel: [phone]<br>Fax: [phone] | | |
|-------------------|-------------------|-----------------------------------------------------------------------------------------------|------------------------------|----------------------------|
| Short Implants | Diameter in<br>mm | Length | Blue Sky<br>Bio<br>Predicate | Predicate Size<br>Range |
| Square Taper | 4.8 | 6mm | K073713 | Ø 4.8-5,6mm;<br>Length 6mm |
| Square Taper | 5.6 | 6mm | K073713 | Ø 4.8-5,6mm:<br>Length 6mm |
| Square Taper | 7.0 | 6mm | K073713 | Ø 4.8-5,6mm;<br>Length 6mm |
| Square Taper | 8.0 | 6mm | K073713 | Ø 4.8-5,6mm;<br>Length 6mm |

Attachment 2

# Intended Use for Two-Piece Implant Systems

- For implantation into any area of the fully 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.
- . Unsplinted narrow implants and angled abutments are not to be used in the posterior areas.
- Taper Hex Implant System is compatible with NobelActive implants and prosthetics .
- Double Hex Implant System is compatible with Astra double hex implants and prosthetics .
- . Square Taper Implant System is compatible with Straumann Bone-Level implants and prosthetics

### Intended Use for One-Piece Implant System

- For implantation into any area of the fully edentulous maxilla and mandible for the support of a . removable or fixed dental prosthesis
- For single tooth or multiple unit prosthesis ●
- For single 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. In edentulous cases four or more implants must be used
- Overdenture Implants are intended for support of removable prosthesis. .

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#### Attachment 2

888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: [phone] Fax: [phone]

# Technological Characteristic Comparison Two Piece Systems

| Feature | Subject Device<br>Modified<br>Blue Sky Bio<br>Dental<br>Implant System | Original<br>Blue Sky Bio Dental<br>Implant System<br>K051507,K060957,<br>K063874, K 73713 | Predicate Devices<br>Nobel Biocare<br>Dental Implant<br>System K071370. | Straumann<br>Implant System<br>K062129 |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------|
| Material<br>(Implants,<br>abutments, fixation<br>screws, healing<br>screws) | Titanium Alloy,<br>Ti-6Al-4V | CP Titanium Grade 4,<br>Ti-6Al-4V | CP Titanium | CP Titanium and<br>Surgical Alloy |
| 1 Stage/ 2 Stage | 1 Stage and 2 Stage | 1 Stage and 2 Stage | 1 Stage and 2 Stage | 1 Stage and 2 Stage |
| Surface | Blasted with<br>resorbable medium,<br>or Aluminum Oxide<br>and Acid Etched | Blasted with<br>resorbable medium, or<br>Aluminum Oxide and<br>Acid Etched | Proprietary galvanic<br>process | Blasted with<br>resorbable<br>medium, and Acid<br>Etched |
| Body Diameter<br>(mm) | 3.25 -5.0 Tapered &<br>Straight and Tapered | 3.3, 4.1, 4.3, 4.8, 5.0,<br>5.6 and 6.0<br>Tapered and Straight | 3.5, 4.3, 5.0<br>Tapered & Straight | 3.3 mm, 4.1mm<br>and 4.8mm |
| Platform Diameter<br>(mm) | 3.25-5.0 | 3.5,4.1,4.3, 4.8, 5.0,<br>6.0, 6.5 | 3.5, 3.9 | 3mm, 3.7mm,<br>4.7mm |
| Lengths (mm) | 6-16 | 6-16 | 10-15 | 8-16mm |
| External Screw<br>Threads | Yes | Yes | Yes | Yes |
| Anti-rotational<br>Feature | Internal Hex with<br>taper, Internal<br>Square with taper | Internal taper with ,<br>internal octagon, or<br>Trilobe | Internal Hex with<br>taper | Internal Square<br>with taper |
| Gamma Sterilized | Yes | Yes | Yes | Yes |
| Two-Piece Screwed<br>Abutment | Yes | Yes | Yes | Yes |
| Overdenture<br>Abutment | Yes | Yes | Yes | Yes |
| Cover Screws,<br>Healing abutments | Yes | Yes | Yes | Yes |
| Instruments<br>(surgical and<br>restorative) | Yes | Yes | Yes | Yes |

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# Technological Characteristic Comparison One Piece System

| Feature | Subject Device<br>Modified<br>Blue Sky Bio Dental<br>Implant System<br>(One Piece) | Predicate Devices<br>Original<br>Blue Sky Bio Dental<br>Implant System<br>K051507 | Predicate Devices<br>Zimmer One-Piece<br>Implant<br>System K052997 |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| One Piece | Yes | Yes | Yes |
| Surface | Blasted with<br>resorbable medium,<br>or Aluminum Oxide<br>and Acid Etched | Blasted with<br>resorbable medium, or<br>Aluminum Oxide and<br>Acid Etched | Blasted with<br>resorbable medium,<br>and acid washed |
| Body Diameter<br>(mm) | 3.0mm | 3.3 mm | 3.0 mm, 3.7mm,<br>4.7mm |
| Externally<br>Threaded Surface | Yes | Yes | Yes |
| Lengths (mm) | 10, 12, 14 mm | 10 -16 mm | 10-16mm |
| Gamma Sterilized | Yes | Yes | Yes |
| Solid Abutment<br>attached to<br>implant for<br>Cemented<br>Restoration | Yes | Yes | Yes |

# Safety and Efficacy

The material, technology and facilities used to produce the modified Blue Sky Bio Dental Implant Systems are the same. Therefore it is substantially equivalent to other commercially available Dental Implant Systems including predicate devices Blue Sky Bio Dental Implant Systems(K051507, K060957, K063874, K073713 ), Nobel Biocare Dental Implant System (K071370), Zimmer Dental Dental Implant System (K052997) and Straumann Dental Implant System (K062129). The technical comparison charts in Tab 5 list the primary technical aspects and specifications that are pertinent to Dental Implant Systems. The Blue Sky Bio dental implant system is as safe and effective as the predicate devices.

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### Performance Tests

Compatibility tests with other systems according to Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document; Root-form Endosseous Dental Implants and Endosseous Dental Abutments: These tests were performed to assess compatibility with predicate devices. The tests showed that the new devices are compatible with predicate devices and the fit is adequate.

Fatigue testing for angled abutments and narrow diameter implants: This test has been conducted according to ISO 14801 for predicate devices. The new devices have larger wall thickness and equal or smaller angulation than the predicate devices and are therefore equivalent or stronger than the predicate devices.

# Conclusion

The Blue Sky Bio Dental Implant system, subject to this submission and the predicate devices are believed to be substantially equivalent. The device constitutes a safe, reliable and effective medical device, meeting all declared requirements of its intended use and the device does not introduce new risks and does not present any adverse health effects or safety risks to patients when used as intended.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is facing to the left.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring. MD 20993-0002

Dr. Albert Zickmann Bule Sky Bio. LLC · 888 E Belvidere Road, Suite 212 Grayslake, Illinois 60030

100 million and the comments of the country of the country of the country of the country of the country of the country of the country of the country of the country of the cou

APR 1 9 2011

Re: K102034

. . . .

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, NHA Dated: April 1, 2011 Received: April 11, 2011

. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 equivalentafor 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 emeral 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. Please note: CDDH, not evaluate information related to contract liability warranties. We remind you, Novever, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as sct 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Ph for

Anthony D. Watson, B.S., M.S., M.B.A. 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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### Attachment 1

# Indications for Use '

510(k) Number (if known):

Device Name: Blue Sky Bio Dental Implant System

Indications for Use:

# Intended Use for Two-Piece Implant Systems

- For implantation into any area of the fully 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.
- Unsplinted narrow implants and angled abutments are not to be used in the posterior areas. .
- . Taper Hex Implant System is compatible with NobelActive implants and prosthetics
- Double Hex Implant System is compatible with Astra double hex implants and prosthetics .
- Square Taper Implant System is compatible with Straumann Bone-Level implants and . prosthetics

## Intended Use for One-Piece Implant System

- For implantation into any area of the fully edentulous maxilla and mandible for the support . of a removable or fixed dental prosthesis
- For single tooth or multiple unit prosthesis .
- For single 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. In edentulous cases four or more implants must be used
- Overdenture Implants are intended for support of removable prosthesis. .

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

Page 1 of 1

510(k) Number:

K62034