MIS CONNECT Conical Connection Abutment

K173326 · Mis Implants Technologies , Ltd. · NHA · Mar 16, 2018 · Dental

Device Facts

• Record ID: K173326
• Device Name: MIS CONNECT Conical Connection Abutment
• Applicant: Mis Implants Technologies , Ltd.
• Product Code: NHA · Dental
• Decision Date: Mar 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dental implant abutments are intended to be used in the upper or lower jaw for supporting tooth replacements to restore chewing function. The MIS CONNECT abutments in combination with endosseous implants are indicated for single or multiple unit reconstructions when screw retained prosthetics are preferred.

Device Story

MIS CONNECT Conical Connection Abutment is an endosseous dental implant abutment; used by dental clinicians to support prosthetic tooth replacements. Device connects to root-form endosseous dental implants; placed above bone level within gingival tissue. Input: mechanical load from prosthetic superstructures (healing caps, cementing caps, temporary abutments). Operation: provides stable foundation for single or multiple unit restorations; connects to implant via conical connection without indexes; secured via integral external thread. Output: mechanical support for artificial teeth. Benefit: restores masticatory function. Used in dental clinics; clinician-operated. Output visualized by clinician during prosthetic placement; affects choice of restoration type and loading protocol.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including fatigue testing (ISO 14801:2007, 5 million cycles), screw loosening testing (Tsuge et al. 2009), sterilization validation (ISO 11137, ISO 17665), and shelf-life testing (ISO 11607-1).

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM F136). Connection: Conical connection without indexes to implant; internal connection to superstructures. Surface: Color anodized. Sterilization: Gamma irradiation (sterile components) or steam sterilization (non-sterile components).

Indications for Use

Indicated for patients requiring prosthetic support for artificial teeth in the upper or lower jaw to restore masticatory function. Narrow implants (Ø3.3mm) are indicated for placement only in mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• MIS V3 Conical Connection Dental Implant System (K163349)

Reference Devices

• Conical Connection Implants (K112162)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 16, 2018

MIS Implants Technologies LTD. % Randy Prebula Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20004

Re: K173326

Trade/Device Name: MIS CONNECT Conical Connection Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 12, 2018 Received: February 12, 2018

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.

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

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.

# Andrew I. Steen -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

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

# Indications for Use

510(k) Number (if known)

#### K173326

Device Name

MIS CONNECT Conical Connection Abutment

Indications for Use (Describe)

MIS Dental Implant Systems 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 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) 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(k) SUMMARY K173326

#### 1. Submitter

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

Contact: Dr. Noa Ofer [phone] [e-mail]

Date Prepared: March 15, 2018

## 2. Device Identification

| | Trade/Proprietary Name: | MIS CONNECT Conical Connection abutment |
|-----------------------|------------------------------------|-----------------------------------------|
| Common/Usual Name: | Dental Implant Abutment | |
| Classification Name: | Endosseous dental implant abutment | |
| Regulation Number: | 21 CFR 872.3630; | |
| Product Code: | NHA | |
| Device Class: | Class II | |
| Classification Panel: | Dental Devices Panel | |

#### 3. Predicate Device(s)

Primary predicate device: MIS V3 Conical Connection Dental Implant System- (K163349). Reference devices: Conical Connection Implants (K112162)

#### 4. Device Description

The MIS CONNECT Conical Connection abutment is an endosseous dental implant abutment device which is intended for use by a dental clinician with a root-form endosseous dental implant to aid in prosthetic rehabilitation, by incorporation in the upper or lower jaw for supporting tooth replacements to restore chewing function. The MIS CONNECT Conical Connection abutment is intended to be used with MIS Conical Connection Implants, such as MIS V3 Conical Connection Dental Implant System and Connection Implants cleared under K112162 and K163349, respectively, and is intended to be placed above the bone level and within the gingival tissue. The MIS CONNECT Conical Connection abutment can be fitted with a variety of complementary accessories, including Healing caps, Cementing caps and Temporary abutments (which are proposed for clearance in the present submission), and also including Prosthetic screws, Impression copings, Analogs, and Scan posts (which are class I products and are therefore exempt from clearance requirements). The MIS CONNECT Conical Connection abutment is not intended to be removed.

# Components:

The MIS CONNECT Conical Connection abutment is to be used in combination with a variety of compatible superstructures (healing caps, cementing caps, and temporary abutments). The superstructures, described below, are manufactured with an external connection, ensuring compatibility to the internal connection of the MIS CONNECT Conical Connection abutment.

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

- Healing caps are premanufactured prosthetic components directly connected to the MIS CONNECT Conical Connection abutments and are indicated as temporary components to allow healing of the soft tissue. They are made from Ti-6Al-4V ELI, and supplied sterile to the user, for single use.
- -Cementing Caps are premanufactured dental implant abutments directly connected to the MIS CONNECT Conical Connection abutments by a prosthetic screw. Cementing caps are available in anti-rotation and free-rotation and are made from Ti6Al-4V ELI, supplied non sterile, and intended for single use.
- -Temporary abutments are premanufactured dental implant abutments directly connected to the MIS CONNECT Conical Connection abutments, intended for use as an aid in temporary prosthetic rehabilitation, for a maximum of 180 days. They are made from Ti-6Al-4V ELI, and are available in anti-rotation and free-rotation configurations. The abutments are supplied nonsterile and intended for single use.

## 5. Indications for Use

MIS Dental Implant Systems 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 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) 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.

#### 6. Substantial Equivalence Discussion

#### Abutments:

The predicate device for the proposed MIS CONNECT Conical Connection abutment is MIS Conical Connection Multi-unit abutment (cleared under K163349). Both devices have similar intended use and the same indications. (Note that Indications for Use of the primary predicate and reference devices are referring to implant bodies and abutments, while the submission only includes abutments. However, as the subject abutments are to be used with implant bodies, it is important to include the implant body indications in the subject device Indications for Use.) They are made of the same material, Ti 6Al-4V ELI, go through a similar manufacturing process, get the same color anodizing surface treatment, and are provided sterilized by gamma irradiation. Both the proposed and the predicate devices are connected directly to the implant using a conical connection without indexes, and by means of an integral external thread. In addition, both the proposed and the predicate devices are intended to be connected with a superstructure for mechanically supporting a restoration.

Differences between the connection of the proposed and predicate device to the superstructure do not raise different types of safety or effectiveness questions and are addressed by fatigue testing per ISO 14801:2007. As the proposed device's intended use is for single unit restorations, as opposed to multiple restorations for the predicate device. Testing was conducted on the reference device MIS Conical Connection CPK abutment (cleared under Conical Connection Implants K116162), which is also intended for single unit restorations and subjected to similar loads. The results of the testing demonstrated equivalence.

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

| Trade Name | MIS CONNECT Conical Connection<br>abutment | MIS V3 Conical Connection Dental<br>Implant System (K163349) | Conical Connection<br>Implants(K112162) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed device | Predicate device | Reference device |
| 510(k) Number | Subject | K163349 | K112162 |
| Manufacturer | MIS Implants Technologies Ltd. | MIS Implants Technologies Ltd. | MIS Implants Technologies Ltd. |
| Device Class | Class II | Class II | Class II |
| Product Code(s) | NHA | NHA, DZE | NHA, DZE |
| Regulation Description | Endosseous dental implant | Endosseous dental implant | Endosseous dental implant |
| Regulation Number | abutment<br>872.3630 | abutment<br>872.3630 | abutment<br>872.3630 |
| Intended use: | Dental implant abutments are<br>intended to be used in the upper or<br>lower jaw for supporting tooth<br>replacements to restore chewing<br>function.<br>The MIS CONNECT abutments in | Dental implant abutments are<br>intended to be used in the upper or<br>lower jaw for supporting tooth<br>replacements to restore chewing<br>function.<br>The Multi-Unit abutments in | Dental implant abutments are<br>intended to be used in the upper or<br>lower jaw used for supporting tooth<br>replacements to restore chewing<br>function.<br>The abutments in combination with |
| | combination with endosseous<br>implants are indicated for single or<br>multiple unit reconstructions when<br>screw retained prosthetics are<br>preferred. | combination with endosseous<br>implants are indicated for multiple<br>unit reconstructions when screw<br>retained prosthetics are preferred. | two-stage endosseous implants are<br>intended to be used as a<br>foundation for anchoring tooth<br>replacements in either jaw.<br>Restorations range from replacing<br>one single tooth to fixed partial<br>dentures using cement-retained<br>supra-constructions. |
| Indications for use: | MIS Dental Implant Systems are<br>intended to be surgically placed in<br>the bone of the upper or lower jaw<br>arches to provide support for<br>prosthetic devices, such as artificial<br>teeth, in order to restore<br>masticatory function.<br>When a one-stage surgical<br>procedure is applied, the implant<br>may be immediately loaded when<br>good primary stability is achieved<br>and the occlusal load is<br>appropriate.<br>Narrow implants ( $\[03.3\]$ mm) are<br>indicated for use in surgical and<br>restorative applications for<br>placement only in the mandibular<br>central, lateral incisor and maxillary<br>lateral incisor regions of partially<br>edentulous jaws, to provide<br>support for prosthetic devices such<br>as artificial teeth, in order to<br>restore the patient chewing<br>function. Mandibular central and<br>lateral incisors must be splinted if<br>using two or more narrow implants<br>adjacent to one another. | MIS Dental Implant Systems are<br>intended to be surgically placed in<br>the bone of the upper or lower jaw<br>arches to provide support for<br>prosthetic devices, such as artificial<br>teeth, in order to restore<br>masticatory function.<br>When a one-stage surgical<br>procedure is applied, the implant<br>may be immediately loaded when<br>good primary stability is achieved<br>and the occlusal load is<br>appropriate.<br>Narrow implants ( $\[03.3\]$ mm) are<br>indicated for use in surgical and<br>restorative applications for<br>placement only in the mandibular<br>central, lateral incisor and maxillary<br>lateral incisor regions of partially<br>edentulous jaws, to provide<br>support for prosthetic devices such<br>as artificial teeth, in order to<br>restore the patient chewing<br>function. Mandibular central and<br>lateral incisors must be splinted if<br>using two or more narrow implants<br>adjacent to one another. | MIS Dental Implant Systems are<br>intended to be surgically placed in<br>the bone of the upper or lower jaw<br>arches to provide support for<br>prosthetic devices, such as artificial<br>teeth, in order to restore<br>masticatory function.<br>When a one-stage surgical<br>procedure is applied, the implant<br>may be immediately loaded when<br>good primary stability is achieved<br>and the occlusal load is<br>appropriate.<br>Narrow implants ( $\[03.3\]$ mm) are<br>indicated for use in surgical and<br>restorative applications for<br>placement only in the mandibular<br>central, lateral incisor and maxillary<br>lateral incisor regions of partially<br>edentulous jaws, to provide<br>support for prosthetic devices such<br>as artificial teeth, in order to<br>restore the patient chewing<br>function. Mandibular central and<br>lateral incisors must be splinted if<br>using two or more narrow implants<br>adjacent to one another. |
| Material(s) | Titanium 6Al-4V ELI per ASTM F136 | Titanium 6Al-4V ELI per ASTM F136 | Titanium 6Al-4V ELI per ASTM F136 |
| Surface Treatment | Anodized after machined | Polished and anodized after<br>machined | Polished and anodized after<br>machined |
| Type of Connection to<br>the Implant | Conical connection<br>without indexes | Conical connection<br>without indexes | Conical Connection<br>with indexes |
| Type of Connection to | Internal connection | External free-rotation | N/A – the reference device is an |
| the Superstructure | Anti-rotation: 3 indexes<br>Free-rotation: no indexes | | abutment being directly connected<br>to the implant. |
| Gingival Height | NP: 2, 3 mm<br>SP: 1.5, 2, 3, 4 mm<br>WP: 1.5, 2, 3, 4 mm | 1,2,3,4,5 mm | 1,2,3,4 mm |
| Diameter | NP/SP/WP: 4 mm | NP/SP: 4.8 mm | NP: 4mm<br>SP:4.8 and 5.5 mm |
| Trade Name | MIS CONNECT Conical Connection<br>abutment<br>Proposed device | MIS V3 Conical Connection Dental<br>Implant System (K163349)<br>Predicate device | Conical Connection<br>Implants(K112162)<br>Reference device |
| Sterilization Method | Gamma radiation | Gamma radiation | Non-sterile |

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

#### Superstructures:

Healing caps, Cementing Caps, and Temporary abutments were compared to equivalent MIS V3 Conical Connection Dental Implant System superstructures cleared under K163349 which share the same indications, are made of the same materials, are manufactured in the same manufacturing conditions and undergo equivalent surface treatments. (Note that Indications for Use of the primary predicate and reference devices are referring to implant bodies and abutments, while the subject submission only includes abutments. However, as the subject abutments are to be used with implant bodies, it is important to include the implant body indications in the subject device Indications for Use.)

No new angulations were introduced. Both the Cementing Caps and the Temporary abutments are provided straight and may not be further manufactured to have an angle; however, any of them may be used with a CONNECT abutment on two implants which diverge up to 40°, but no more than 20° per implant. Single unit loading may include angulation up to 20º. Although the predicate cement retained and temporary abutments are indicated for a divergence of 30%, the difference in divergence is accounted for in the fatigue testing.

The differences between subject and predicate devices did not alter the intended use and new issues of safety and effectiveness were not raised.

| Trade Name | MIS CONNECT Superstructures | MIS V3 Conical Connection Dental Implant System<br>(K163349) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed device | Predicate device |
| 510(k) Number | Subject | K163349…