Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Device Description

Blue Sky Bio Zygomatic Implant System submission includes threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. The zygomatic implants are provided with an internal hexagon connection and a tapered internal hexagon interface for connection to the subject abutments. The internal hexagon connection implants are provided with a body diameter of 4.7 mm and platform diameters of 3.5 mm and 4.5 mm. The tapered internal hexagon connection implants are provided with a body diameter of 4.3 mm and a narrow platform (NP) connection, and with a body diameter of 5.0 mm with a regular platform (RP) connection. All implants are provided in multiple overall threaded lengths ranging from 35 mm to 55 mm. This submission includes mating abutments with platform diameters of 3.5, 4.3, and 4.5 mm. and each abutment diameter is provided with 17° and 30° of angulation. All subject device abutments are for support of screw-retained overdenture prosthetic restorations. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device zygomatic implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The previously cleared abutment screws also are made of material conforming to ASTM F136.

AI/ML Overview

This is a 510(k) premarket notification for a dental implant system, which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

The document mainly focuses on comparing the new device's characteristics to those of predicate devices and showing that any differences do not raise new questions of safety or effectiveness.

Here's a breakdown of the information that is available or applicable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, formal "acceptance criteria" in the sense of predefined thresholds for clinical performance against a disease are not provided. Instead, the device demonstrates performance through engineering analysis, dimensional analysis, and dynamic compression-bending testing to show it is comparable to predicate devices.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Summary)
Biocompatibility	Referenced from predicate devices K102034 and K060957, implying the new device materials are biocompatible.
Dimensional Analysis	Compared to predicate devices. The subject device implants are in the same overall length range as the primary predicate K141777 (35 mm to 52.5 mm), and the 55 mm length is supported by reference predicate K093562. Smaller body diameter (4.3 mm) is supported by reference predicate K093562 (4.05 mm) and dynamic compression-bending testing. Abutment platform diameters (3.5, 4.3, 4.5 mm) and angulations (17°, 30°) are presented.
Dynamic Compression-Bending Testing (Fatigue Performance)	According to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). Demonstrated fatigue performance substantially equivalent to that of the primary predicate K141777, especially for worst-case constructs (smallest diameter implant - Taper Hex 4.3 mm body diameter - and largest angulation - 30°). This implies meeting or exceeding the predicate's fatigue resistance as tested per the standard.
Material Composition	Ti-6Al-4V conforming to ASTM F136, same as previously cleared components in K102034 and K060957.
Surface Finish	Grit blasted and acid etched for endosseous surface, same as predicate implants in K102034 and K060957.
Sterilization & Packaging	Similar materials and processes as described in K102034 and K060957 (implants sterilized, abutments provided non-sterile for sterilization by user).

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in terms of a "number of cases" or "number of patients" as this was a non-clinical submission. For the dynamic compression-bending testing per ISO 14801, the standard typically specifies the number of samples required for fatigue testing, but the exact number used in this specific test is not provided in the summary.
Data Provenance: Non-clinical (lab-based engineering and material testing). Not applicable in terms of country of origin or retrospective/prospective for clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in a clinical sense (e.g., disease presence/absence determined by expert radiologists) is not relevant for this type of non-clinical device submission.

4. Adjudication method for the test set:

Not applicable. No expert adjudication process as this was a non-clinical submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical dental implant system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

For Biocompatibility: Material specifications (ASTM F136) and prior clearance of similar materials in predicate devices (K102034 and K060957).
For Dimensional Analysis: Engineering drawings and measurements, compared against predicate device specifications.
For Dynamic Compression-Bending Testing: The performance requirements of the ISO 14801 standard and the comparative performance of the primary predicate device (K141777).

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2016

Blue Sky Bio, LLC c/o Kevin A. Thomas, Ph.D. Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K153064

Trade/Device Name: Blue Sky Bio Zygomatic Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 31, 2016 Received: March 31, 2016

Dear Dr. Thomas:

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 Federal Register.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K153064

Device Name

Blue Sky Bio Zygomatic Implant System

Indications for Use (Describe)

Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Type of Use (Select one or both, as applicable)

☑ Prescription (Part 21 CFR 201.5 Subpart D)	□ Over-The-Counter (Part 21 CFR 201.6 Subpart E)
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X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Blue Sky Bio, LLC Blue Sky Bio Zygomatic Implant System

April 28, 2016

ADMINISTRATIVE INFORMATION

Manufacturer Name	Blue Sky Bio, LLC
	888 E Belvidere Road, Suite 212
	Grayslake, IL 60030
	Telephone	+1 718-376-0422
	Fax	+1 888-234-3685
Official Contact	Michele Vovolka
	Vice President of RA/QA
Representative/Consultant	Kevin A. Thomas, PhDLinda K. Schulz, BSDH, RDHPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130
	Telephone:	+1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	kthomas@paxmed.com lschulz@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Blue Sky Bio Zygomatic Implant System
Common Name	Endosseous dental implantEndosseous dental implant abutment
Classification Regulations	21 CFR 872.3640
Product Code	DZENHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

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PREDICATE DEVICE INFORMATION

Primary predicate device:

K141777, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA

Reference predicate devices:

K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K060957, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K093562, Zygomatic Implant System, Southern Implants, Inc.

INTENDED USE

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K102034 and K060957), engineering analysis, dimensional analysis, and dynamic compression-bending testing of the Taper Hex 4.3 mm body diameter implant with the NP platform according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. No clinical data were included in this submission.

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EQUIVALENCE TO MARKETED DEVICE

Blue Sky Bio, LLC submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K141777, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA;

K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC;

K060957, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC; and

K093562, Zygomatic Implant System, Southern Implants, Inc.

A comparison of the technological characteristics of the subject device and the primary predicate device K141777 is provided in the following table.

	Subject Device	Primary Predicate Device
Comparison	Blue Sky Bio, LLCBlue Sky Bio Zygomatic Implant SystemK153064	JJGC Indústria e Comércio de Materiais Dentários SANeodent Implant SystemK141777
Indications for Use	Blue Sky Bio Zygomatic Implant System is indicatedfor surgical installation in the zygoma region, in casesof severe jaw resorption, in order to restore patientesthetics and chewing function. Blue Sky Biozygomatic implants are recommended for the posterior(pre-molar/molar) region, one implant on each side,with at least two standard dental implants in theanterior region to support a fixed restoration. Blue SkyBio zygomatic implants may be loaded immediatelywhen good primary stability is achieved and withappropriate occlusal loading.	Zygomatic Implants are indicated for surgicalinstallation in the zygoma region, in cases of severejaw resorption, in order to restore patient esthetics andchewing function. Zygomatic Implants arerecommended for the posterior (pre-molar/molar)region, one implant on each side, with at least twostandard dental implants in the anterior region tosupport a fixed restoration. Zygomatic Implants maybe loaded immediately when good primary stability isachieved and with appropriate occlusal loading.
Implants
Design	Threaded root-form implant to be used with matingabutments	Threaded root-form implant to be used with matingabutments
Implant body ØandPlatform Ø	Internal hex connectionImplant body Ø: 4.7 mmAbutment platform Ø: 3.5 mm, 4.5 mm(implant body tapers at apical portion)Tapered internal hex connectionImplant body Ø: 4.3 mm with NP 3.5 mmabutment platformImplant body Ø: 5.0 mm with RP 4.3 mmabutment platform(implant body tapers at apical portion)	External hex and Morse taperImplant body Ø: 4.4 mm tapering to 3.9 mmPlatform Ø: 4.1 mm
Implant Lengths	All implants:35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55 mm	External hex:30, 35, 40, 45, 47.5, 50, 52.5 mmMorse taper:30, 35, 40, 42.5, 45, 47.5, 50, 52.5 mm
Implant-Abutment Interface
Type	Internal hex with 12° taperInternal hex with 45° bevel	External hexMorse taper
Implant body-abutmentconnection angle	n/a	45°
Abutments
Platform Diameter	Internal hex connection: 3.5 mm, 4.5 mmTapered internal hex connection: 4.3 mm	4.1 mm
Abutment Angle	17°, 30°	0° (straight)

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	Subject Device	Primary Predicate Device
Comparison	Blue Sky Bio, LLCBlue Sky Bio Zygomatic Implant SystemK153064	JJGC Indústria e Comércio de Materiais Dentários SANeodent Implant SystemK141777
Materials
Implants	Ti-6Al-4V	F67 unalloyed titanium, grade 4
Implant Surface	Grit blasted and acid etched	Machined
Abutments	Ti-6Al-4V	F136 Ti-6A1-4V ELI
Abutment Screws	Ti-6Al-4V	External hex: F136 Ti-6A1-4V ELI

The subject device and the primary predicate K141777 have substantially equivalent indications for use, including restoration of patient esthetics and chewing function, and immediate loading when used with standard dental implants placed in the anterior region to support a fixed restoration. The implants of the subject device and the predicate device K141777 have similar designs and dimensions, including lengths appropriate for zygomatic placement.

The subject zygomatic implants are very similar in design to endosseous dental implants from Blue Sky Bio cleared in K102034 and K060957. except for a slight change in the endosseous thread and the longer lengths appropriate for zygomatic placement. The subject zygomatic implants are provided in a range of implant body diameters (maximum endosseous thread diameters) of 4.3 mm to 5.0 mm, the same as the predicate implants cleared in K102034 and K060957. The smaller subject device implant body (4.3 mm diameter) as compared to the primary predicate K141777 (4.4 mm diameter) is supported by the reference predicate K093562 (4.05 mm body diameter), and by and dynamic compression-bending testing according to ISO 14801.

The subject device implants are provided in the same range of overall lengths as the primary predicate K141777 (35 mm to 52.5 mm), and the subject device 55 mm length implant is supported by the reference predicate K093562.

This submission includes abutments with an internal hexagon and tapered internal hexagon interfaces for connection to the subject zygomatic implants. The subject device abutments are provided with platform diameters of 3.5. 4.3. and 4.5 mm. and angulation of 17° or 30°. The subject device abutments are substantially equivalent to the abutments cleared in K102034 and K060957 in terms of implant-abutment connections, platform diameters, angulation, and materials. The subject abutments are to be used with compatible abutment screws cleared in K102034 and K060957.

Differences between the subject device and the primary predicate K141777 include the location of angulation correction (subject device includes abutments with angulation, versus K141777 implant designs included angulation at the abutment-implant connection), and the amount of angulation (subject device 17° or 30°, versus K141777 only 45°). These differences between the subject device and the primary predicate are supported by dynamic compression-bending testing according to ISO 14801. Dynamic testing of worst case subject device constructs consisting of the smallest diameter implant (Taper Hex 4.3 mm body diameter) and largest angulation (30°)

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demonstrated fatigue performance substantially equivalent to that of the primary predicate K141777.

The subject device implants and abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), the same as these components cleared in K102034 and K060957. The endosseous surface finish of the subject device implants is the same as the predicate implants cleared in K102034 and K060957.

The subject device implants have similar packaging and are sterilized using the same materials and processes as described in K102034 and K060957. The subject device abutments are provided nonsterile in similar packaging and are to be sterilized using the same processes as described in K102034 and K060957.

CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and the diameter and angulation of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 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.