MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments

K172505 · Mis Implants Technologies , Ltd. · DZE · Dec 28, 2017 · Dental

Device Facts

• Record ID: K172505
• Device Name: MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
• Applicant: Mis Implants Technologies , Ltd.
• Product Code: DZE · Dental
• Decision Date: Dec 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MIS dental implant system 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 masticatory 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. Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only 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. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

Device Story

Endosseous dental implant system; includes tapered, screw-type implants and various prosthetic abutments (cover screws, healing caps, cement-retained, gold, multi-unit, OT-equators, ball attachments, temporary). Implants placed surgically into jaw bone by dental professionals; provide foundation for prosthetic teeth. Implants feature internal conical connection; self-tapping threads. Abutments connect to implants via prosthetic screws or direct attachment. System restores masticatory function. Clinical benefit: tooth replacement/restoration. Used in dental clinics. Output: physical support for dental prosthetics. No software or AI components.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including fatigue testing (ISO 14801:2007), sterilization validation (ISO 11137, ISO 17665), shelf-life testing (ISO 11607), and risk analysis (ISO 14971).

Technological Characteristics

Implants: Ti-6Al-4V ELI (ASTM F136), anodized/sand-blasted/acid-etched surface, tapered threaded design, conical connection. Abutments: Ti-6Al-4V ELI, gold alloy, PEEK, or POM. Sterilization: Gamma radiation (sterile) or steam sterilization (non-sterile).

Indications for Use

Indicated for partially edentulous patients requiring tooth replacement in upper or lower jaw arches. Narrow implants (3.3mm/UNO) restricted to mandibular central/lateral incisors and maxillary lateral incisors; requires splinting for adjacent narrow implants. Supports immediate loading if primary stability and occlusal load are appropriate.

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

• ANKYLOS C/X Implant System (K140347)

Reference Devices

• A.B. DENTAL DEVICES Dental Implants System (K162482)
• MIS V3 Conical Connection Dental Implant System (K163349)
• MIS Conical Connection Implants (K112162)
• Straumann NNC Protective Caps (K113410)

Submission Summary (Full Text)

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MIS Implants Technologies Ltd. % Randy Prebula Partner Hogan Lovells US LLP 555 13th Street, NW Washington, District of Columbia 20004 December 27, 2017

Re: K172505

Trade/Device Name: MIS C1 Narrow Platform Conical Connection Implant System MIS C1 Wide Platform Conical Connection Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 30, 2017 Received: November 30, 2017

Dear Randy Prebula:

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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Mary S. Runner -S

For Tina Kiang, Ph.D. Acting 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) K172505

#### Device Name

MIS C1 Narrow Platform Conical Connection Implant System MIS C1 Wide Platform Conical Connection Abutments

#### Indications for Use (Describe)

MIS dental implant system 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 masticatory 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.

Narrow implants (03.3mm & UNO) are indicated for use in surgical and restorative applications for placement only 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. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

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)

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Image /page/3/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 "M" and "I" connected and the "S" slightly offset. The text "Implants Technologies Ltd." is written in a smaller font to the right of the logo.

# K172505 510(k) Summary

## 1. Submitter

MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park 2015600 ISRAEL Telephone: [phone] Fax: [phone]

Contact: Arbel Shezaf [phone] [e-mail]

Date Prepared: December 28, 2017

## 2. US Agent: Motti Weisman - VP Marketing

MIS Implants Technologies Inc. 18-00 Fair Lawn Ave Fair Lawn NJ 07410 Phone: [phone] Fax: [phone]

## 3. Device Identification

Trade/Proprietary Name: MIS C1 Narrow Platform Conical Connection Implant System MIS C1 Wide Platform Conical Connection Abutments Common/Usual Name: Dental Implant Classification Name: Endosseous dental implant Requlation Number: 872.3640; Product Code: DZE, NHA Device Class: Class II Classification Panel: Dental Devices Panel

## 4. Predicate Device(s)

Primary predicate device: ANKYLOS C/X Implant System cleared under 510(k) K140347. Reference devices:

- A.B. DENTAL DEVICES® Dental Implants System K162482 .
- MIS V3 Conical Connection Dental Implant System K163349 .
- MIS Conical Connection Implants K112162 ●
- Straumann NNC Protective Caps K113410 .

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Image /page/4/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in a stylized font, with the "I" having a vertical line extending above the other letters. To the right of the logo is the text "Implants Technologies Ltd" in a smaller font.

## 5. Device Description

The MIS C1 NP Conical Connection dental implants are manufactured from Ti-6AI-4V ELI. The conical root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The implants are self-tapping, root-form with tapered threads. They have a 3.3 mm diameter and the following lengths: 10mm, 11.5mm, 13mm and 16mm. The internal part of the implant and the lower part of the abutment are anodized for coloring purposes for a quick identification of the diameter and to ensure the adequate abutments. The Implants are supplied sterile.

This submission also includes wide platform (WP) conical connection abutments which are compatible to the previously cleared (K112162) MIS conical connection wide platform implants.

### Components:

The MIS C1 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants. The abutments in this submission include NP abutments, compatible with the C1 NP implants also submitted here; and WP abutments compatible with previously cleared (K112162) MIS conical connection WP implants.

- Cover screws and healing caps are premanufactured prosthetic components directly connected to ı the endosseous dental implants and are indicated as temporary components to allow healing of the soft tissue. They are made of Ti-6Al-4V ELI, and supplied sterile to the user, for single use.
- । Cement- Retained Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant by a prosthetic screw. Cement retained abutments are available straight or angulated, in different heights and diameters. The angulated abutments allow a maximum anqulation of 25°. The straight abutments are intended for 0 degree angulation and straight implantation only. They are made of Ti6Al-4V ELI, and supplied non sterile, to be steam sterilized by the user according to the labeling, intended for single use.
- । CPK abutments are cement retained abutments intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments are intended for 00 angulation and straight implantation only. They are supplied non sterile, to be steam sterilized by the user according to the labeling, and intended for single use.
- Plastic healing caps are premanufactured abutments intended to cover the CPK abutment until the permanent restoration is ready. They are made from PEEK and intended to be used for up to 180 days. The plastic healing caps are delivered non sterile to the user, for single use, to be sterilized by steam sterilization. Different caps are available for use with narrow, standard, and wide platforms.
- Gold Plastic abutments are intended for permanent restoration, for either single or multiple tooth । screw retained restorations. The lower part of the abutment which connects directly to the implant is made of gold alloy, and the upper part is made of plastic part is dissolved once the casting is done. Gold abutments are intended for 0° angulation and straight implantation only. The

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Image /page/5/Picture/0 description: The image shows a logo with the letters 'mis' in blue. The 'm' and 's' are connected by a curved line at the bottom. To the right of the letters is the word 'Implementation' in a smaller font size. The logo is simple and modern.

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abutments are supplied non sterile, to be steam sterilized by the user according to the labeling, and intended for single use.

- । Multi-Unit abutments are indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the prosthesis into the multi-unit abutment or connection to a fixed overdenture bar. Multi-units are available in angulations between 17-309. The Multi units are made of Ti-6Al-4V ELI. They are supplied sterile and intended for single use.
- OT-Equators & Ball Attachments are screw retained dental implant abutments connected directly to । the endosseous dental implant by their lower threaded part, and are used in completely edentulous jaws for anchoring an overdenture to allow its insertion and removal.
- -Temporary abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant, intended for use as an aid in temporary prosthetic rehabilitation, for a maximum of 180 days. They are available in Ti-6Al-4V ELI and in natural PEEK, and in anti-rotation and free-rotation. The abutments are supplied non sterilized by the user according to the labeling and intended for single use.

## 6. Indications for Use

MIS dental implant system 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 masticatory 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.

Narrow implants (Ø3.3mm & UNO) are indicated for use in surqical and restorative applications for placement only 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. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

## 7. Substantial Equivalence Discussion

- a. Implants: The predicate device for the MIS C1 NP conical connection dental implants is the ANKYLOS C/X (K140347). Both devices have similar indications, although the predicate device states that implants 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The subject device does not contain this limitation as its shortest device is 10 mm in length. The length range of the subject device is within the range of the predicate. Although the diameter of the subject device is somewhat smaller, 3.3 vs 3.5 mm, it possesses at least equivalent strength as compared to the predicate device. Their geometrical design is similar with minor differences which do not raise different safety or efficacy questions. Fatique testing per ISO 14801:2007 assessed the impact of these differences and demonstrates at least equivalent performance. The predicate device is indicated for all positions in the jaws, while the subject C1 NP implants are indicated for the mandibular central, lateral incisor and maxillary lateral incisor regions, and must be splinted if using two or more narrow implants adjacent to one another. The differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. A reference device, A.B. DENTAL DEVICES® Dental Implants System (K162482) with the same 3.3mm diameter and similar indications for use as the subject device is also

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Image /page/6/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in a stylized, connected font, with the "i" having a dot above it. To the right of the logo is the text "Implants Technologies Ltd.", indicating the company's name and industry.

presented. A comparison of implant characteristics demonstrates substantial equivalence to the predicate device.

## Table 1: Comparison of subject and predicate Implants

| Trade Name | MIS C1 NP Conical<br>Connection Dental<br>Implants | ANKYLOS C/X Implant<br>System | A.B. DENTAL DEVICES®<br>Dental Implants System |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172505 | K140347 | K162482 |
| Manufacturer | MIS Implants Technologies Ltd. | DENTSPLY Implants | A.B. Dental Device Ltd. |
| Device Class | Class II | Class II | Class II |
| Product Code(s) | DZE | DZE | DZE |
| Regulation<br>Description | Endosseous dental implant | Endosseous dental implant | Endosseous dental implant |
| Regulation<br>Number | 872.3640 | 872.3640 | 872.3640 |
| Intended use: | Intended to be surgically placed<br>in the bone of the upper or<br>lower jaw arches for anchoring<br>or supporting tooth<br>replacement to restore<br>chewing function. | Intended to be surgically<br>placed in the bone of the<br>upper or lower jaw arches for<br>anchoring or supporting tooth<br>replacement to restore<br>chewing function. | Intended to be surgically placed in<br>the bone of the upper or lower<br>jaw arches for anchoring or<br>supporting tooth replacement to<br>restore chewing function. |
| | Indications for use: MIS dental implant system is<br>intended to be surgically placed<br>in the bone of the upper or<br>lower jaw arches to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order<br>to restore masticatory function.<br>When a one-stage surgical<br>procedure is applied, the<br>implant may be immediately<br>loaded when good primary<br>stability is achieved and the<br>occlusal load is appropriate.<br>Narrow implants (Ø3.3mm &<br>UNO) are indicated for use in<br>surgical and restorative<br>applications for placement only<br>in the mandibular central,<br>lateral incisor and maxillary<br>lateral incisor regions of<br>partially edentulous jaws, to<br>provide support for prosthetic<br>devices such as artificial teeth,<br>in order to restore the patient<br>chewing function. Mandibular<br>central and lateral incisors must<br>be splinted if using two or more<br>narrow implants adjacent to<br>one another. | ANKYLOS® C/X Implants of 8<br>mm in length or longer are for<br>single-stage or two-stage<br>surgical procedures and<br>cemented, removable or screw<br>retained restorations. The<br>ANKYLOS® C/X Implants may<br>be used for immediate<br>placement and function on<br>single tooth and/or multiple<br>tooth applications when<br>adequate primary stability is<br>achievable, with appropriate<br>occlusal loading, in order to<br>restore chewing function.<br>Multiple tooth applications may<br>be splinted.<br>ANKYLOS® C/X Implants of 6.6<br>mm in length are for two-stage<br>surgical procedures and<br>cemented, removable or screw<br>retained restorations. The<br>ANKYLOS® C/X Implants may be<br>used for immediate placement on<br>single tooth and/or multiple tooth<br>applications when adequate<br>primary stability is achievable,<br>with appropriate occlusal loading,<br>in order to restore chewing<br>function. | A.B. DENTAL DEVICES® Dental<br>Implants System is indicated for<br>use in surgical and restorative<br>applications for placement in the<br>bone of the upper or lower jaw to<br>provide support for prosthetic<br>devices, such as artificial teeth, in<br>order to restore the patient's<br>chewing function. A.B. DENTAL<br>DEVICES® Dental<br>Implants System is indicated<br>also for immediate loading when<br>good primary stability is<br>achieved and with appropriate<br>occlusal loading.<br>Two Stage Implants: I22, I5, I55,<br>I10.<br>P4 and P14 angled abutments are<br>to be used only with standard<br>platform implants 3.5 mm in<br>diameter or larger. |
| | | Multiple tooth applications<br>may be splinted. | |
| Implant Material | Titanium 6Al-4V ELI per ASTM<br>F136 | CP Titanium grade 2 | Titanium 6Al-4V ELI |
| Surface Treatment | Anodized ,sand blasted and<br>acid etched | Sand blasted and acid etched | Sand blasted with CaP, except<br>for 0.5mm distal part of the neck<br>which is smooth. |
| Body design | Tapered design, threaded | Tapered design, threaded | Tapered design, threaded |
| Connection Type | Conical with indexes | Conical with indexes | Conical with internal hex |
| Type of implant | Bone level implant | Bone level implant | Bone level implant |
| Implant Diameters | 3.3 mm | 3.5 mm | Ø 3.3 mm |
| Implant Lengths | 10, 11.5, 13 and 16 mm | 6.6, 8, 9.5, 11, 14, 17 mm | 10, 11.5, 13 and 16 mm |
| Neck Design | Cylindrical | Cylindrical | Cylindrical |
| Apex | Domed apex | Domed apex | Flat apex |
| Thread | Dual | Dual | Dual |
| Sterilization<br>Method | Radiation | Radiation | Radiation |

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Image /page/7/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "mis" in a stylized font, with the "i" having a vertical line extending above the other letters. To the right of the letters is the text "Implants Technologies Ltd." in a smaller font. The logo is simple and modern, and the text is clear and easy to read.

- b. Abutments: Healing caps, cover screws, cement retained abutments, CPK abutments, gold abutments, multi-units, temporary abutments, OT-equators and ball attachments were compared to equivalent MIS conical connection abutments, which share the same indications, are made of the same materials, manufactured in the same facility with the same manufacturing conditions and undergo the same surface treatments and were cleared under K163349. No new angulations were introduced. The subject worst case abutment was tested for fatigue limits and met the pre-determined success criteria. The differences between subject and predicate devices did not alter the intended use and new issues of safety and effectiveness were not raised.
## Table 2 - Comparison of subject and predicate Abutments Characteristics

| Trade Name MIS C1 Conical Connection Abutments MIS V3 Conical Connection Abutments | | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject | K166349 |
| Manufacturer | MIS Implants Technologies Ltd. | MIS Implants Technologies Ltd. |
| Device Class | Class II | Class II |
| Product Code(s) | NHA | NHA |
| Regulation<br>Description | Endosseous dental implant abutment | Endosseous dental implant abutment |
| Regulation<br>Number | 872.3630 | 872.3630 |
| Intended use: | Dental implant abutments are intended to be used<br>in the upper or lower jaw used for supporting tooth<br>replacements to restore chewing function. The<br>abutments in combination with two-stage<br>endosseous implants are intended to be used as a | Dental implant abutments are intended to be used in<br>the upper or lower jaw used for supporting tooth<br>replacements to restore chewing function. The<br>abutments in combination with two-stage<br>endosseous implants are intended to be used as a |

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Prises Ltd

#### MIS C1 Conical Connection Abutments

#### MIS V3 Conical Connection Abutments

foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to fixed partial dentures using cementretained supra-constructions.

foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to fixed partial dentures using cementretained supra-constructions.

| Indications for<br>use: | MIS dental implant system is intended to be<br>surgically placed in the bone of the upper or lower<br>jaw arches to provide support for prosthetic<br>devices, such as artificial teeth, in order to restore<br>masticatory function. When a one-stage surgical<br>procedure is applied, the implant may be<br>immediately loaded when good primary stability is<br>achieved and the occlusal load is appropriate.<br>Narrow implants (Ø3.3mm & UNO) are indicated<br>for use in surgical and restorative applications for<br>placement only in the mandibular central, lateral<br>incisor and maxillary lateral incisor regions of<br>partially edentulous jaws, to provide support for<br>prosthetic devices such as artificial teeth, in order<br>to restore the patient chewing…