(87 days)
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No
The provided text describes a dental implant system and its intended use, focusing on the physical device and surgical procedures. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
This device is a dental implant system used for supporting dental prostheses, which is a restorative and supportive function, not a therapeutic one. It does not treat or cure a disease or condition.
No
The device is described as a dental implant system used for supporting dental prostheses, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "root form dental implants of various lengths and diameters 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a "root form dental implant system" intended for "implantation into any area of the fully edentulous maxilla and mandible" and "partially edentulous maxilla and mandible" for the "support of a removable or fixed dental prosthesis." This involves a surgical procedure and the device is implanted directly into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a medical device (specifically, a dental implant) and not an in vitro diagnostic device.
N/A
Intended Use / 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
DZE
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 are supplied sterile or not sterile and are labeled accordingly. The system is suitable for a one-stage and two-stage protocol.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
maxilla and mandible
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
K05/507
SEP - 2 2005
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 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 | 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 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 are supplied sterile or not sterile and are labeled accordingly. The system is suitable for a one-stage and two-stage protocol.
Intended 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.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND 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
SEP - 2 2005
Dr. Albert Zickmann Blue Sky Bio, LLC 888 East Belvidere, Suite 212 Grayslake, Illinois 60030
Re: K051507
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: May 10, 2005 Received: June 7, 2005
Dear Dr. Zickmann:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your become mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use surced in the encreating of the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Antichunches, or to ab roos and in the entire Act (Act) that do not require approval of a premarket the rederal I ood, Drug, Drug, therefore, market the device, subject to the general approvin approvisions of the Act. The general controls provisions of the Act include controls providents or a 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 IT your device is enabilional controls. Existing major regulations affecting (1 Mrx), it may of such 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 - Dr. Zickmann
Please be advised that FDA's issuance of a substantial equivalence determination does not r least oc advisor that I Da determination that your device complies with other requirements modifine and regulations and regulations administered by other Federal agencies. of the Act of ally I outeral but is requirements, including, but not limited to: registration 1 od must comply with an all are i 100 bing (21 CFR Part 801); good manufacturing practice and ilsting (21 OF Reviews (QS) regulation (QS) regulation (21 CFR Part 820); and if requirements as set for in als qualify ijon 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) This letter will and w your of substantial equivalence of your device to a premarket notification. - The 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), If you desire speome at 100 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 may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylette K. Michael, Cins.
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
Indications for Use Statement
Page 1 of 1
KD51507 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
- removation 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 picce implants for single stage procedure only .
- One prece implane for and immediate function when multiple units are splinted and for single . r of minediate placement and ministration in type I or type II bone and under appropriate unns when daequate mitted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ OR |
|---|---|
| (Division Sign-Off) | Susan Runne |
Over-The-Counter Use (Optional Format 1-2-96)
Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K051507
Blue Sky Bio, LLC 510(k)
Page 9 Proprietary & Confidential