The Uno - One Piece Screw-Type 3.0 mm Dental 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, to provide support for prosthetic devices of partificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment one piose bend Mandibular central and lateral incisors must be splinted if using two or more 3.0 mm implants adjacent to one another. The If acting on a can factured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment one piooo oone matting are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

Device Description

The Uno - One Piece Screw-Type Dental Implant is indicated for use in surgical and restorative applications for placement in the bone of 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 - One Piece Screw-Type Dental Implant is made of one piece solid material comprised of the implant and abutment combination.

The Uno implants are provided in two diameters. The Uno 3.0 mm dental implant is indicated for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions. The Uno 3.5 mm dental implant is indicated for placement in the premolar, cuspid and incisor regions.

The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02. The Implants are provided in several lengths of 10mm, 13mm and 16mm with diameters of 3.0mm, 3.5mm. The implants surface is sand blasted and acid etched to improve the osseointegration. The implants are tapered with double thread (2mm pitch) for fast insertion.

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

AI/ML Overview

This 510(k) submission for the "Uno - One Piece Screw-Type Dental Implant" does not describe a study to prove the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set details) are not applicable or cannot be extracted from the provided text.

The document primarily details the device description, intended use, and argues for its equivalence to a previously cleared device.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The submission does not define specific "acceptance criteria" for performance that would be met through testing. Instead, it relies on demonstrating that the device is manufactured from the same material and has similar technological characteristics to the predicate device, implying equivalent performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No test set data is described. The submission relies on a comparison to a predicate device, not new clinical or performance testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No test set requiring ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set requiring adjudication is described.

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 dental implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to "human readers improving with AI" is irrelevant to this submission.

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

Not Applicable. This is a physical medical device (dental implant), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No new clinical or performance data requiring ground truth is presented in this submission. The "ground truth" for the submission is the established safety and effectiveness of the predicate device based on its prior clearance.

8. The sample size for the training set

Not Applicable. There is no training set mentioned as this is not a machine learning device.

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

Not Applicable. There is no training set mentioned.

Summary of what the submission does present regarding equivalence:

The submission argues for Substantial Equivalence based on the following:

Same Intended Use: The Uno implant has the same intended use as the ZIMMER DENTAL ONE-PIECE IMPLANT (K052997). Both are for placement in the jaw to support prosthetic devices and restore chewing function.
Equivalent Performance Characteristics: The submission states that
- Both products are manufactured from the same material: Titanium alloy Gr. 5 complying with standard ASTM F136-02.
- "All other technological characteristics are similar and show equivalent performance capabilities." (This is a general statement, and specific comparative data is not provided in the text.)
Material: Titanium alloy Gr. 5 complying with ASTM F136-02 for both the Uno implant and the predicate device.

Conclusion stated in the document:
"The evaluation of the Uno - One Piece Screw-Type Dental Implants does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device."

Essentially, the "study" proving the device meets criteria is the argument for substantial equivalence to a device already deemed safe and effective by the FDA, rather than new, independent testing against pre-defined acceptance criteria.

Summary

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APR 2 2 2008

510(k) Summary:

Uno - One Piece Screw-Type Dental Implant

Company Name -

MIS - Implants Technologies Ltd. POB 110 Shlomi Industrial Zone Shlomi 22832 ISRAEL Telephone: +972-4-980-9966 Fax: +972-4-980-9944

Establishment Registration Number: 3004203816

Iman Khorshid Contact Name: Quality Manager Telephone: +972-4-980-9966 Fax: +972-4-980-9944 E-mail: iman@mis-implants.com

US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 278 Broadway Elmwood Park, NJ 07407 Phone: (201) 797-9144 Fax: (201) 797-9145 E-mail: mis.service@verizon.net

Date prepared: January 17, 2008

Trade Name: Uno - One Piece Screw-Type Dental Implant

Classification name: Implants, Endosseous, Root Form

Common/usual name: Uno - One Piece Screw-Type Dental Implant

Product Code: DZE

Regulation No.: 872.3640

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Class: II

Panel identification: Dental Devices Panel

Predicate Device: ZIMMER DENTAL ONE-PIECE IMPLANT from ZIMMER DENTAL INC. , 1900 Aston ave. Carlsbad, CA 92008, cleared under 510(k) no. K052997.

Description of the device:

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

Indications for Use:

The Uno - One Piece Screw-Type 3.0 mm Dental 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, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment combination.

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The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment combination. The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

Substantial Equivalence:

The Uno - One Piece Screw-Type Dental Implants have the same intended use as the ZIMMER DENTAL ONE-PIECE IMPLANT from ZIMMER DENTAL INC. , 1900 Aston ave. Carlsbad, CA 92008, cleared under 510(k) no. K052997, and have equivalent performance characteristics. Both products are manufactured from the same Titanium alloy. All other technological characteristics are similar and show equivalent performance capabilities. The Uno - One Piece Screw-Type Dental Implants are therefore substantially equivalent to the predicate device.

Conclusion -

The evaluation of the Uno - One Piece Screw-Type Dental Implants does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, with a double helix design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2008

Ms. Iman Khorshid Quality Manager M.I.S. Implants Technologies Limited P.O.BOX 110 Shlomi Industrial Zone Shlomi 22832 ISRAEL

Re: K080162

Trade/Device Name: Uno - One Piece Screw-Type Dental Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Codes: DZE Dated: March 20, 2008 Received: March 31, 2008

Dear Ms. Khorshid:

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 such additional controls. Existing major regulations affecting vour 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. Khorshid

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

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K080162

INDICATIONS FOR USE

K080162 510(k) Number (if known):

Uno - One Piece Screw-Type Dental Implant Device Name:

The Uno - One Piece Screw-Type 3.0 mm Dental Implant is indicated Indications for Use: for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices of partificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment one piose bend Mandibular central and lateral incisors must be splinted if using two or more 3.0 mm implants adjacent to one another. The If acting on a can factured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment one piooo oone matting are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

X OR Prescription Use (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)

Susan Ruopp

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices

510(k) Number: K080162

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.