SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS

K103089 · Mis - Implant Technologies , Ltd. · DZE · Sep 15, 2011 · Dental

Device Facts

• Record ID: K103089
• Device Name: SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS
• Applicant: Mis - Implant Technologies , Ltd.
• Product Code: DZE · Dental
• Decision Date: Sep 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K103089 · Sep 15, 2011	SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS	Mis - Implant Technologies , Ltd.	Published clinical literature; Clinical case studies	The sponsor utilized a literature review and retrospective case studies to support the clinical evaluation of the MIS Short Implants, demonstrating safety and effectiveness through 30 months of follow-up.	Literature review; Case studies; Clinical evaluation

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical evaluation based on literature review and case studies; Literature review and case studies; Follow-up/Duration: 30 months	—	Not applicable for this study	Safety and effectiveness

Indications for Use

MIS dental implants are 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. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. MIS short implants are to be used only with straight abutments.

Device Story

MIS Short Implants are self-tapping, root-form, two-piece screw-type dental implants; surgically placed in upper or lower jaw bone by dental professionals; provide support for prosthetic devices (artificial teeth) to restore chewing function. Device components include cover screws, healing caps, and straight abutments. Implants are provided in 6.0mm length and 4.2mm, 5.0mm, and 6.0mm diameters. Clinical benefit includes restoration of masticatory function. Used in clinical dental settings; provider evaluates stability to determine if immediate loading is appropriate.

Clinical Evidence

Clinical evaluation based on literature review and case studies with 30-month follow-up. Bench testing included fatigue testing.

Technological Characteristics

Material: Ti6Al4V ELI (ASTM F 136-08). Design: Self-tapping, root-form, two-piece screw-type. Dimensions: 6.0mm length; 4.2mm, 5.0mm, 6.0mm diameters. Surface: Sand-blasted. Connectivity: Internal hexagon. Sterilization: Provided sterile. Single-use only.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw arches to support prosthetic devices (artificial teeth) and restore chewing function. Suitable for one-stage surgical procedures with immediate loading if primary stability is achieved and occlusal load is appropriate. Restricted to use with straight abutments.

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

• 4.5x6.0mm and 6.0x6.0mm dental implants (K050712)
• 5.0x6.0mm dental implant (K042637)
• OsseoSpeed 4.0S – 6 mm implant (K063779)

Submission Summary (Full Text)

{0}------------------------------------------------

KI03089

Image /page/0/Picture/1 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized font, with the "S" being a curved shape. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font.

# 510(k) Summary:

SEP 1 5 2011

### MIS Short Implants

- MIS Implants Technologies Ltd. Company Name: MIS Implants Technology
P.O.Box 7, Bar Lev Industrial Park, 20156, ISRAEL 20150, 1510-4-9016800 Fax: [phone]
# Establishment Registration Number: 3004203816

US Agent:

Motti Weisman - VP Marketing MIS Implants Technologies Inc. MIS Implants Technology
14-25 Plaza Rd. Suite S-3-5 Fair Lawn New Jersey; 07410 Phone: [phone] [phone] Fax: Fax: 2 (2 mail: [e-mail]

Date prepared: August 21st, 2011

Trade Name: MIS Short Implants

Classification name: Implants, Endosseous, Root Form

Common/usual name: Dental Implant

Product Code: DZE

Regulation No.: 872.3640

Class: II

Panel identification: Dental Devices Panel

510 (k) MIS Short Implants Section E - Page 1 of 5

{1}------------------------------------------------

#### hnologies Ltd.

#### Predicate Device:

Predicate Device:
4.5x6.0mm and 6.0x6.0mm dental implants cleared under 510(k) K050712 and 4.5x6.0mm and 6.0x6.0mm dental implants cleared and on the 501Arborway,
5.0x6.0mm cleared under 510(k) K042637, both from Bicon, Inc. 501Arborway, 1 Boston, Massachusetts, 02130;

Boston, Massachusetts, 02130;
OsseoSpeed 4.0S – 6 mm implant cleared under 510(k) K063779 from Astra Tech
OsseoSpeed 4.0S – 6 mm implant cleared under 510 kb care and 1245 OsseoSpeed 4.05 = 0 han = 1.
Inc., 890 Winter Street, Suite 310, Waltham, MA 02451 .
Inc., 890 Winter Street, Suite 310, Waltham, MA 02451 .

## Description of the device:

Description of the device:
The MIS short implants are self tapping, root-form, two piece screw type dental The MIS short implants are self tapping, 1001-1011; the personations for placement in
implants, indicated for use in surgical and restorative applications for placement in implants, indicated for use in surgical and restoration of institution such as artificial
the upper or lower jaw to provide support for prosthetic devices such as artificial the upper or fower just to f
eeth, in order to restore the patient chewing for a form length

teeth, in order to restore the patient chewing ranetices.
The MIS short implants are provided in 6.0mm length and 4.2mm, 5.0 mm, and

6.0mm diameters, as follows: 6.0mm diameters, as follows:
Seven internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
1.0mm internal hexagon 6.0mm the diameter 4.20mm, 5.0 mm and 6.0mm Seven internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Biocom internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm Biocom internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Lance internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Internal hexagon 6.0mm length a

Lance internal nexagon on The implants surface is sand blasted and actues whereas the implant is to be used in
The MIS short implants are two piece devices whereas the implant is and The MIS short implants are two piece academents and superstructures.
combination with cover screws, bealing caps, abutments and supers combination with cover screws, healing caps, abanieman and ASTM
The MIS short implants are made of Ti6ALAV ELI complying with standard ASTM
The MIS short implants are made of The MIS short implants are made of TibALAV LEI compose of the MIS short in the MIS short imm-4Vanadium ELI
F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Va F 136-08- Standard - 136-06- Surgical Implant.
(Extra Low Interstitial) Alloy for Surgical Implant.

### Indications for Use:

Indications for Use:
MIS dental implants are intended to be surgically placed in the bone of the upper or MIS dental implants are intended to be surgically places and as artificial teeth, in
lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in

order jaw around a patient's chewing function. order to restore a patient's chewing function.
When a one stage surgical procedure is applied, the implant may be immediately When a one stage surgical procedure is applical list and the occlusal load is appropriate.
Ioaded when good primary stability is achieved and the occlusal load is appropriate

loaded when good primary stability is
MIS short implants are to be used only with straight abutments.
The short implants are to be used only with straight abutments.

510 (k) MIS Short Implants 310 (K) E - Page 2 of 5

{2}------------------------------------------------

## Substantial Equivalence:

Substantial Equivalence:
The MIS short implants have the same intended use as the 4.5x6.0mm dental implans The MIS short implants have the same intentional as as as a manufactured to the mass cleared
6.0x6.0mm cleared under 510(k) KD50712 and 5.0x6.0mm 6.0x6.0mm cleared under 510(x) Ro371 ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . under 510(k) K042637, both from Bicoll, the Street, Speed implant cleared under
Massachusetts, 02130, and the OsseoSpeed 4.0S – 6 mm implant cleared under Massachusetts, 02130, and the OsseoSpeca 4.05 = 6 mm. ........................................................................................................................ 510(k) K063779 from Astra Tech Inc., 690 w hise excepts to these products are
02451, and have equivalent performance characteristics. All these products are 02451, and have equivalent performance characteristics of the missteristics.
manufactured from the same Titanium alloy. All other technological characteristics manufactured from the same Titanum andy. The MIS short implants
are similar and show equivalent performance capabilities. The MIS short implants
are similar and show equival are similar and show equivalent posses.
are therefore substantially equivalent to their predicate devices.
Therefore substantially equivalent to their predicate devices.
Ther

cal characteristics – comparative table:

| | Technological characteristics - compar... | | | |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>For Use | MIS Short Implants<br>from MIS Implants<br>Technologies Ltd.<br><br>MIS dental<br>implants are<br>intended to be<br>surgically placed in<br>the bone of the upper<br>or lower jaw arches<br>to provide support<br>for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore a<br>patient's chewing<br>function.<br><br>When a one stage<br>surgical procedure<br>is applied, the<br>implant may be<br>immediately<br>loaded when good<br>primary stability is<br>achieved and the<br>occlusal load is | 4.5x6.0mm<br>6.0x6.0mm<br>Implants from<br>Bicon, Inc.<br><br>The 4.5x6.0 mm and<br>the 6.0mmx6.0mm<br>implants are designed<br>for use in edentulous<br>sites in the mandible<br>or maxilla for support<br>of a complete denture<br>prosthesis, a terminal<br>or intermediate<br>abutment for fixed<br>bridgework, partial<br>dentures, or a single<br>tooth replacement. | 5.0x6.0 mm Implant<br>from Bicon, Inc.<br><br>The 5.0x6.0 mm<br>implant is intended to<br>be surgically placed<br>in the maxilla or<br>mandible to provide<br>support for prosthetic<br>devices to restore the<br>patient's chewing<br>function. | OsseoSpeed from Astra<br>Tech Inc.<br><br>The OsseoSpeed™ 4.0S - 6<br>mm is intended to be used<br>to replace missing<br>masticatory functional units<br>(teeth) in single or multiple<br>unit applications within the<br>mandible or maxilla where<br>immediate implant stability<br>may be obtained. The<br>device may be used equally<br>well in a single-stage or<br>two-stage surgical<br>procedure. It is indicated<br>for immediate implantation<br>in extraction sited or<br>implantation in partially<br>healed or completely<br>healed alveolar ridge<br>situations. When a one-stage surgical approach is applied, the implant may be<br>immediately loaded after<br>implantation where<br>immediate implant stability |
| | MIS Short Implants<br>from MIS Implants<br>Technologies Ltd. | 4.5x6.0mm<br>6.0x6.0mm<br>Implants from<br>Bicon, Inc. | 5.0x6.0 mm Implant<br>from Bicon, Inc. | OsseoSpeed from Astra<br>Tech Inc. |
| | appropriate.<br>MIS short implants<br>are to be used only<br>with straight<br>abutments. | | | may be obtained.<br>The fluoride-modified<br>surface, though having a<br>fluoride ion level far below<br>that needed for caries<br>prevention in teeth,<br>provides a favorable<br>substrate for bone<br>attachment and<br>osseointegration.<br>OsseoSpeed 4.0S – 6 mm is<br>especially indicated for use<br>in soft bone applications<br>where implants with other<br>implant surface treatments<br>may be less effective.<br>Because initial stability<br>may be difficult to obtain in<br>Type IV bone, immediate<br>loading of single tooth<br>restorations may not be<br>appropriate in such<br>situations. |
| Supplied<br>Sterile | Yes | Yes | Yes | Yes |
| Re-use | No | No | No | No |
| Material of<br>Construction | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Shape | Screw type | Screw type | Screw type | Screw type |
| Length | 6.0 mm | 6.0 mm | 6.0 mm | 4.0 |
| Thread<br>Diameter | 4.2, 5.0 and 6.0 mm | 4.5 and 6.0 mm | 5.0 mm | Straight and up to 20° |
| Abutment<br>Material of<br>Construction<br>of<br>Abutments | Straight<br>Titanium Alloy | Straight and up to 25°<br>Titanium Alloy | Straight and up to 25°<br>Titanium Alloy | Straight and up to 20°<br>Titanium Alloy |
| Surface | None | None | None | None |

510 (k) MIS Short Implants 310 (K) Mis Page 3 of 5

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "nis" in a stylized font. The letters are bold and connected, with the "s" resembling a backwards "u". To the right of the word "nis" is the word "Implan", which is likely the beginning of the word "Implant". The image appears to be a logo or part of a title.

510 (k) MIS Short Implants
Section E - Page 4 of 5

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized font, with the "S" being a curved line. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font. The text is slightly angled upwards.

## Non – clinical tests:

Non – clinical tests:
Fatigue test was performed on MIS short implants and its results were found
ed the state was performed on Marts devices Fatigue test was F

Clinical tests:
A clinical evaluation, based on literature review and case studies with 30 months
. follow up, has been performed.

#### Conclusion:

Conclusion:
The evaluation of the MIS short implants does not raise any additional concerns
and the MIS short implants of the MIS short implants may therefore be The evaluation of the MIS short implants does not the may therefore be
regarding safety and effectiveness and the MIS short implants may therefore be regarding safety and effectiveness .
considered substantially equivalent to their predicate device

510 (k) MIS Short Implants Section E - Page 5 of 5

{5}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure.

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

Ms. Iman Khorshid V P. QA & RA MIS Implants Technologies, Limited P.O. Box 7 Bar Lev Industrial Park 20156. ISRAEL

Re: Ki03089

Trade/Device Name: MIS Short Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 11, 2011 Received: September 13, 2011

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. 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, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

SEP 1 5 2011

{6}------------------------------------------------

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); 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/Reportal/roblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.

Sincerely vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Implants Technologies Ltd.

#### INDICATIONS FOR USE

| 510(k) Number: | K103089 |
|----------------|---------|
|----------------|---------|

Device Name: MIS Short Implants

Indications for Use: MIS dental implants are 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.

> When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

MIS short implants are to be used only with straight abutments.

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)

Susan Runner

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

KID30599 510(k) Number:

510 (k) MIS Short Implants Section D- Page 1 of 1