(90 days)
Not Found
Not Found
No
The summary describes a dental implant system and drills, focusing on materials, dimensions, and surgical procedures. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device, a dental implant system and drills, is intended to support dental prostheses and make osteotomies. While it aids in restoring function, it does not directly treat or cure a disease or medical condition in the therapeutic sense.
No
The provided text explicitly states the device is a "Dental Implant System" intended to "give support to single or multiple units fixed dental prosthesis" and "support to overdentures." It also describes "Drills" for making "ostotomies." These functions relate to surgical implantation and prosthetic support, not the diagnosis of a disease or condition.
No
The device description clearly states it is a "Dental Implant System" and describes physical components like implants and drills, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Blue Sky Bio Dental Implant System is intended for implantation into the jawbone to support dental prostheses. The drills are for preparing the bone for these implants. This is a surgical procedure involving direct interaction with the patient's body, not testing samples outside the body.
The text focuses on the surgical placement and function of the implants within the patient's anatomy, which is characteristic of a surgical or implantable medical device, not an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae, maxilla and mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
0
Blue Sky Bio, LLC
888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: 847-548-8499 Fax: 847-548-849 Email: azickmann@blueskybio.com
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.
1
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.
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 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
3
Blue Sky Bio, LLC
888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: 847-548-8499 Fax: 847-548-849 Email: azickmann@blueskybio.com
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
Page_1_of_1
December 2006
Blue Sky Bio, LLC 510(k)
Blue Sky Bio, LLC 510(k)
Page 9□
Proprietary & Confidential