UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT

K080162 · Mis Implants Technologies , Ltd. · DZE · Apr 22, 2008 · Dental

Device Facts

• Record ID: K080162
• Device Name: UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
• Applicant: Mis Implants Technologies , Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

One-piece screw-type dental implant; integrates implant and abutment into single solid unit. Manufactured from Titanium alloy (ASTM F136-02); features sand-blasted, acid-etched surface for osseointegration; tapered design with double thread (2mm pitch) for rapid insertion. Surgically placed into upper or lower jaw bone by dental professionals. Provides structural support for prosthetic artificial teeth. Restores patient chewing function. Supplied sterile for single use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy Gr. 5 (ASTM F136-02); one-piece solid implant/abutment design; sand-blasted and acid-etched surface; tapered geometry with double thread (2mm pitch); diameters 3.0mm and 3.5mm; lengths 10mm, 13mm, 16mm; sterile, single-use.

Indications for Use

Indicated for partially edentulous patients requiring dental implants for prosthetic support and restoration of chewing function. 3.0 mm implants for mandibular central/lateral incisors and maxillary lateral incisors; 3.5 mm implants for premolar, cuspid, and incisor regions. 3.0 mm implants require splinting if placed adjacently.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ZIMMER DENTAL ONE-PIECE IMPLANT (K052997)

Submission Summary (Full Text)

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APR 2 2 2008

is

# 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: [phone] Fax: [phone]

Establishment Registration Number: 3004203816

Iman Khorshid Contact Name: Quality Manager Telephone: [phone] Fax: [phone] E-mail: [e-mail]

US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 278 Broadway Elmwood Park, NJ 07407 Phone: [phone] Fax: [phone] E-mail: [e-mail]

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 - 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.

#### 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 [phone]. 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 [phone] or [phone] 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