iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy" Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Device Description

iSy Implant System implants are self-tapping, root form, tapered endosseous dental implants made of titanium. The implant has a smooth machined surface in the transgingival portion, and a Promote surface on the endosseous portion. The subject device implants are provided in two lengths (7.3 and 16 mm) and three diameters (3.8, 4.4 and 5.0 mm). The subject device includes four abutment types, gingiva former, temporary abutment, Locator® and Esthomic Abutment. Abutments are compatible with all three diameters (3.8, 4.4 and 5.0 mm). The Esthomic abutment is available with three design angulations (0°, 15°, 20°). iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) premarket notification clearance letter for the iSy® Implant System, which establishes its substantial equivalence to previously marketed devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

October 2, 2015

Altatec GmbH c/o Ms. Linda Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K151599

Trade/Device Name: iSy® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: September 1, 2015 Received: September 2, 2015

Dear Ms. Schulz:

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 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 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/Resourcesfor You/Industry/default.htm. 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 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) K151599

Device Name

iSy® Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Altatec GmbH iSy® Implant System

September 1, 2015

ADMINISTRATIVE INFORMATION

Manufacturer Name	Altatec GmbHMaybachstrasse 5D-71299 Wimsheim, GermanyTelephone: +49 7044 9445 0Fax: +49 7044 9445 723
Official Contact	Colleen BoswellDirector of RA/QA Ortho Organizers, Inc
Representative/Consultant	Linda K. Schulz, BSDH, RDHFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 (858) 792-1235Fax: +1 (858) 792-1236Email: lschulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	iSy® Implant System
Common Name	Endosseous dental implantEndosseous dental implant abutment
Classification Name	Implant, endosseous, root formEndosseous dental implant abutment
Classification Regulations	21 CFR 872.3640 Class II
Product Code	DZE, NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

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INTENDED USE

iSy Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to : ISO 11137-1 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose, ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1; ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.

Clinical data were not submitted in this premarket notification.

EQUIVALENCE TO MARKETED DEVICE

Primary Predicate: Altatec GmbH, iSy® Implant System, K133991; Reference Predicates: Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments, K083496; Altatec GmbH, CAMLOG Logfit Prosthetic System, K071213; Astra Tech AB. OsseoSpeed™ Plus. K120414: and Zest Anchors, Inc, Modification To Locator Implant Anchor, K072878; Zest Anchors, LLC, Locator RTx, K150925.

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omparison of the technological characteristics of the subject device and predicate devices is shown in the Table of Substanti
quivalence below.

	Subject Device		Predicate Device
	Altatec GmbH	Altatec GmbH	Altatec GmbH	Astra Tech AB	Zest Anchors, Inc
	iSy® Implant System	iSy® Implant System	CAMLOG Implant System ModifiedImplants and Abutments	OsseoSpeed™ Plus	Modification to:Locator ImplantAnchor
	K133991	K083496	K120414	K072878
Design
Implant Length, mm	7.3, 16	9, 11, 13	9.0, 11.0, 13.0, 16	6, 8, 9, 11, 13, 15, 17	NA
Implant Diameter, mm	3.8, 4.4, 5.0	3.8, 4.4, 5.0	3.3, 3.8, 4.3, 5.0, 6.0	3.0, 3.6, 4.2,4.8, 5.4	NA
Abutment Diameter, mm	3.8, 3.9, 4.8, 5.4, 5.9, 6.6	6.5	3.3, 3.8, 4.3, 5.0, 6.0	3.0, 3.6, 4.2, 4.8, 5.4	3.25 to 6.5
Abutment Angle	Straight, 15°, 20°	Straight, up to 30°	Straight, 15°, 20°	Straight, 15°, 20°, 30°	Straight
Material
Implant	CP Ti Gr 4	CP Ti Gr 4	CP Ti Gr 4	CP Ti Gr 4	NA
Abutments andAbutment Screw	Ti-6Al-4V ELI;	Ti-6Al-4V ELI;Zirconia	Ti-6Al-4V ELI;Zirconia	Ti-6Al-4V ELI;Zirconia, Gold alloy	Ti-6Al-4V ELI

of Substantial Equivaler

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CONCLUSION

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

Overall, the subject device has the following similarities to the predicate devices:

. has the same intended use,
uses the same operating principle, ●
. incorporates the same basic design,
incorporates the same materials, and .
has similar packaging and is sterilized using the same materials and processes. .

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.