The UNO Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by adjacent teeth and roots, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more Ø3.0 mm implants adjacent to one another. The UNO Narrow Implant is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Device Description

The UNO Narrow Implant is a self tapping, root-form, two piece screw type dental implant, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The UNO Narrow Implant is provided in one diameter (3 mm) in the following lengths: 10mm, 11.5 mm, 13mm and 16mm. The implants are tapered with double thread (2mm pitch) for fast insertion. The implants surface is sand blasted and acid etched. The UNO Narrow Implant is a two piece device whereas the implant is to be used in combination with replaceable ball attachments anchor screws and healing caps. The Uno implants and healing caps are supplied sterile and are intended for single use only. The ball attachment anchor screws are supplied non-sterile since immediately after their placement the ball attachments are used for impression coping in plastic materials. The UNO Narrow Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-02- Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

AI/ML Overview

This document is a 510(k) summary for the UNO Narrow Implant, a dental device. It asserts substantial equivalence to a predicate device, the OsseoSpeed™ Narrow from Astra Tech AB. The summary does not describe an AI/ML device, nor does it present any studies or data related to AI/ML device performance. Therefore, I cannot provide the requested information about acceptance criteria or study details from this document.

The document discusses the following:

Company Name: MIS Implants Technologies Ltd.
Device Name: UNO Narrow Implant
Predicate Device: OsseoSpeed™ Narrow from Astra Tech AB (K080396)
Description of the device: Self-tapping, root-form, two-piece screw-type dental implant, made of Ti6AL4V ELI.
Indications for Use: Placement in specific regions of partially edentulous jaws where horizontal space is limited, to support prosthetic devices.
Substantial Equivalence: Claimed due to same intended use and equivalent performance characteristics, manufactured from the same Titanium alloy.
Conclusion: The device is substantially equivalent to its predicate.

There is no mention of acceptance criteria, device performance metrics, sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance studies, training sets, or how ground truth was established, as these are concepts relevant to AI/ML device testing, which is not applicable to this 510(k) submission.

Summary

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510(k) Summary:

UNO Narrow Implant

JAN - 5 2010

Company Name: MIS Implants Technologies Ltd. P.O.Box 7, Bar Lev Industrial Park, 20156, ISRAEL Telephone: +972-4-9016800 Fax: +972-4-9918623

Establishment Registration Number: 3004203816

Contact Name: Iman Khorshid V.P QA & RA Telephone: +972-4-9016800 Fax: +972-4-9918623 E-mail: iman@mis-implants.com
US Agent:

Motti Weisman - VP Marketing MIS Implants Technologies Inc. 14-25 Plaza Rd. Suite S-3-5 Fair Lawn New Jersey; 07410 Phone: (201) 797-9144 Fax: (201) 797-9145 E-mail: service(@misimplants.com

Date prepared: August 12, 2009

Trade Name: UNO Narrow Implant

Classification name: Implants, Endosseous, Root Form

Common/usual name: Dental Implant

Product Code: DZE: NHA

Regulation No .: 872.3640; 872.3630

Class: II

Panel identification: Dental Devices Panel

510 (k) - K092555- UNO Narrow Implant Section E - Page 1 of 4

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Predicate Device:

OssseoSpeed ™ Narrow from Astra Tech AB , Aminogatan 1, P.O.Box 14, Mölndal, Sweden SE-431-21 cleared under 510(k) No. K080396.

Description of the device:

The UNO Narrow Implant is provided in one diameter (3 mm) in the following lengths: 10mm, 11.5 mm, 13mm and 16mm. See Annex 1 of this section.

The implants are tapered with double thread (2mm pitch) for fast insertion.

The implants surface is sand blasted and acid etched .See Annex 2 of this section.

The UNO Narrow Implant is a two piece device whereas the implant is to be used in combination with replaceable ball attachments anchor screws and healing caps. See implantation procedure in Annex 3 of this section.

The Uno implants and healing caps are supplied sterile and are intended for single use only.

The ball attachment anchor screws are supplied non-sterile since immediately after their placement the ball attachments are used for impression coping in plastic materials.

The UNO Narrow Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-02- Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

Indications for Use:

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order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more Ø3.0 mm implants adjacent to one another. The UNO Narrow Implant is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Substantial Equivalence:

The UNO Narrow Implants have the same intended use as the OsseoSpeed™ Narrow Implant from Astra Tech AB . Aminogatan 1, P.O.Box 14, Mölndal, Sweden SE-431-21 cleared under 510(k) No. K080396, and have equivalent performance characteristics. Both products are manufactured from the same Titanium alloy. All other technological characteristics are similar except for the surface treatment and show equivalent performance capabilities. The UNO Narrow Implants are therefore substantially equivalent to the predicate device.

Conclusion:

The evaluation of the UNO Narrow Implants does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.

510 {k} - K092555- UNO Narrow Implant Section E - Page 4 of 4

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Image /page/3/Picture/0 description: The image contains the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling the perimeter, with the acronym "USA" included. In the center is a stylized emblem, consisting of a symbol that resembles a bird or a wave-like design, which is the department's official logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Iman Korshid Vice President MIS Implants Technologies Limited P.O.B. 110, Shlomi Industrial Zone Shlomi 22832 ISRAEL

JAN - 5 2010

Re: K092555

Trade/Device Name: UNO Narrow Implant Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 17, 2009 Received: December 22, 2009

Dear Ms. Korshid:

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 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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Page 2- Ms. Korshid

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,

Th for

Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE

K092555 510(k) Number (if known):

UNO Narrow Implant Device Name:

Indications for Use: The UNO Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by adjacent teeth and roots, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more Ø3.0 mm implants adjacent to one another. The UNO Narrow Implant is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Prescription Use X OR (Part 21 CFR 801 Subpart D)

Over the Counter Use (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 Mieling for MSN

(Division Sign-Off) livision of Anesthesiology, General Hospital iection Control, Dental Devices

510 (k) - K092555- UNO Narrow Implant Section D- Page 1 of 1

510(k) Number:

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.