(119 days)
Not Found
No
The 510(k) summary describes a dental implant system and its compatibility with existing systems. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on compatibility and fatigue testing, not algorithmic performance.
Yes
The device, a dental implant system, is intended to support a dental prosthesis and restore chewing function, which directly addresses a health condition (edentulism) and restores a physiological function.
No
The device is a dental implant system intended for the restoration of teeth and support of dental prostheses, which are therapeutic functions, not diagnostic.
No
The device description explicitly states it consists of "root form dental implants of various lengths and associated abutment systems," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description and intended use clearly state that this device is a dental implant system. It is designed to be surgically implanted into the jawbone to support dental prostheses and restore chewing function.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens from the patient. Its function is purely mechanical and structural within the body.
Therefore, the Blue Sky Bio 3mm Double Hex Dental Implant System falls under the category of a medical device (specifically, a dental implant), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Blue Sky Bio 3mm Double Hex implants are primarily intended for restoration of mandibular . incisors and maxillary lateral incisors
- Blue Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the . fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws
- Implants can be placed in immediate function on single-tooth and/or multiple tooth applica-. tions when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
- Multi-unit abutments for fixed restorations are to be used only for multiple splinted restora-. tions.
- In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded . cases.
- Blue Sky Bio 3mm Double Hex Dental Implant System is compatible with Astra Osseospeed . Narrow Dental Implant System.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and associated abutment systems, which provide the clinician with cement retained , screw 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular incisors and maxillary lateral incisors, fully and partially edentulous ridge, jaws
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)
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 the same wall thickness and equal or smaller angulation than the predicate devices and are therefore equivalent or stronger than the predicate devices.
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.
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
JAN 2 7 2012
888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: 718-376 0422 Fax: 888-234 3685 Email: azickmann@blueskybio.com
510(K) Summary
General Information
| Classification Name: | Endosseous Implant | |
|---|---|---|
| Common Name: | Prosthetic Dental Implant System | |
| Trade Name: | Blue Sky Bio Dental Taper Hex 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 | June 2011 |
Device Description
The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and associated abutment systems, which provide the clinician with cement retained , screw 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 .
- Blue Sky Bio 3mm Double Hex implants are primarily intended for restoration of mandibular . incisors and maxillary lateral incisors
- Blue Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the . fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws
- Implants can be placed in immediate function on single-tooth and/or multiple tooth applica-. tions when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
- Multi-unit abutments for fixed restorations are to be used only for multiple splinted restora-. tions.
- In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded . cases.
- Blue Sky Bio 3mm Double Hex Dental Implant System is compatible with Astra Osseospeed . Narrow Dental Implant System.
Blue Sky Bio, LLC 510(k)
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ
Page 9
August 2011
1
... ..........................................................................................................................................................................
.
Technological Characteristic Comparison
| Feature | Subject Device
Blue Sky Bio 3mm Dental
Implant System (Double Hex
3mm) | Predicate Device
Astra Tech 3mm Dental
Implant System K080396. |
|----------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Material | CP Titanium Grade 4,
Ti-6Al-4V | CP Titanium
Grade 4 |
| 1 Stage/ 2 Stage | 2 Stage | 2 Stage |
| Surface | Blasted with resorbable
medium, or Aluminum Oxide
and acid etched | Blasted with titanium oxide and acid
etched |
| Body Diameter
(mm) | 3 mm | 3mm |
| Platform
Diameter
(mm) | 3mm | 3mm |
| Lengths (mm) | 10, 11, 13, 15, 17 mm | 11, 13, 15, 17 mm |
| External Screw
Threads | Yes | Yes |
| Anti-rotational
Feature | Internal Double Hex with taper, | Internal Double Hex with taper |
| Gamma Sterilized | Yes | Yes |
| Solid abutment | Yes | Yes |
| Two-Piece
Screwed
Abutment | Yes | Yes |
| Overdenture
abutment | Yes | Yes |
| Instruments
(surgical and
restorative) | Yes | Yes |
| Angled Abutment | Yes Multiunit | Yes TiDesign |
| Single Unit | Yes | Yes |
| Multiple Unit | Yes | Yes |
Blue Sky Bio, LLC 510(k)
August 2011
: |
2
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 Osseospeed Narrow Dental Implant System Astratech (K080396) and to Blue Sky Bio Dental Implant System (K073713)
The technical comparison charts list the primary technical aspects and specifications that are pertinent to Dental Implant Systems. The 3mm Blue Sky Bio dental implant system is as safe and effective as the predicate devices.
Non-Pyrogenic Statement
No claims are made that the products are non-pyrogenic.
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 the same 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.
Blue Sky Bio, LLC 510(k)
August 2011
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 7 2012
Ms. Michele Vovolka Correspondent Blue Sky Bio, LLC 888 E Belvidere Road, Suite 212 Grayslake, Illinois 60030
Re: K112875
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: January 8, 2012 Received: January 19, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 Eederal Register.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
G. ler. Anthony Watson
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
5
Blue Sky Bio, LLC
888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: 718-376 0422 Fax: 888-234 3685 Email: azickmann@blueskybio.com
Indications for Use Statement
Page 1 of 1
510(k) Number (if Known): K112875
Device Name: Blue Sky Bio Dental Implant System
Indications for Use:
- Blue Sky Bio 3mm Double Hex implants are primarily intended for restoration of mandibular . incisors and maxillary lateral incisors
- more Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the . fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws
- Implants can be placed in immediate function on single-tooth and/or multiple tooth applica-. tions when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
- enowing raileriem.
The abutments for fixed restorations are to be used only for multiple splinted restora-. tions. - In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded ◆ cases.
- Blue Sky Bio 3mm Double Hex Dental Implants are compatible with Astra Osseospeed . Narrow abutments.
- Rurow abutinents!
Blue Sky Bio 3mm Double Hex Abutments are compatible with Astra Osseospeed Narrow . Implants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801:109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division of Anesthesiologie Befleral Hospital
Page 14
Proprietary & Confidentianfection Control, Dental Devices
510(k) Number:
(Division Sigh-Off)
Blue Sky Bio, LLC 510(k)