INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS

K141211 · Prismatik Dentalcraft, Inc. · NHA · Oct 22, 2014 · Dental

Device Facts

• Record ID: K141211
• Device Name: INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: NHA · Dental
• Decision Date: Oct 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Indications for Use

Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive Titanium Abutments are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.

Device Story

Inclusive Titanium Abutments are premanufactured prosthetic components; used to support prosthetic restorations (crowns, bridges) on endosseous dental implants. Device consists of titanium alloy (ASTM F136) abutment and screw; machined construction; straight (0°) design. Placed by dental professionals in clinical settings; abutment sits on implant shoulder; secured via screw. Provides stable interface for prosthetic rehabilitation. Benefits patient by restoring dental function and aesthetics.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including reliability calculation, fatigue strength testing, and static load failure testing of worst-case assembled implant/abutment systems per FDA guidance for root-form endosseous dental implants.

Technological Characteristics

Material: Titanium Alloy (ASTM F136). Design: Machined, straight (0°). Connection: Octagonal. Implant/Screw Seat: Tapered. Dimensions: 13.30 mm length, 9.44 mm diameter (blank); 8 mm screw length, M2.0 thread. Sterilization: Validated per ANSI/AAMI ST79 and ISO 17665-1.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants. Compatible with Straumann Standard Plus Tissue Level Implants (RN 4.1/4.8mm and WN 4.8mm).

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

• ITI synOcta Meso Abutments (K033243)
• Inclusive Titanium Abutment Blanks (K083192)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, all facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

OCtober 22, 2014

Prismatik Dentalcraft, Incorporated Mr. Armin Zehtabchi Senior Regulatory Affairs 2212 Dupont Drive, Suite P Irvine, CA 92612

Re: K141211

Trade/Device Name: Inclusive® Titanium Abutments, compatible with Straumann® Standard Plus Tissue Level Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 19, 2014 Received: September 22, 2014

Dear Mr. Zehtabchi:

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}------------------------------------------------

Page 2 - Mr. Zehtabchi

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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

Image /page/2/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.

## 004 Indications for Use Statement

510(k) Number (if known): K141211

| Device Name: | Inclusive ^® Titanium Abutments, compatible with Straumann ^® Standard Plus Tissue Level Implants |
|--------------|-----------------------------------------------------------------------------------------------------------------------|
|--------------|-----------------------------------------------------------------------------------------------------------------------|

| Indications for Use: | Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.<br>Inclusive Titanium Abutments are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

## Type of Use

Prescription Use: Yes > No □ (Part 21 CFR 801 Subpart D)

Over-the-Counter Use: Yes □ No ∑ (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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

Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.

## 005 510(k) Summary

[As Required by 21 CFR 807.92]

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements 21 CFR 807.92.

### SUBMITTER INFORMATION A.

B.

| Company Name: | Prismatik Dentalcraft, Inc. |
|---------------------------|--------------------------------------------------------------------------------------------------|
| Company Address: | 2212 Dupont Dr., Suite P<br>Irvine, CA 92612 |
| Company Phone: | [phone] |
| Company FAX: | 949-553-0924 |
| Primary Contact Person: | Armin Zehtabchi, [phone]<br>Senior RA |
| Secondary Contact Person: | Marilyn Pourazar, [phone]<br>Sr. Director, RA/QA |
| Date Summary Prepared: | October 21, 2014 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Inclusive® Titanium Abutments, compatible with<br>Straumann® Standard Plus Tissue Level Implants |
| Common Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 872.3630 |
| Product Code: | NHA |
| Device Class: | II |
| Review Panel: | Dental |

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

Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the word "PRISMATIK" in bold, black letters on the right side. Below the word "PRISMATIK" is the phrase "DENTALCRAFT, INC." in a smaller, black font. The logo is simple and modern, and the use of color in the triangle makes it visually appealing.

#### C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name: ITI synOcta Meso Abutments (K033243) Inclusive Titanium Abutment Blanks (K083192)

#### D. DEVICE DESCRIPTION

Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. Abutments are to be provided straight and are not intended for any angulation correction.

| | Inclusive Titanium Abutments, compatible with<br>Straumann Standard Plus Tissue Level Implants | |
|------------------------|------------------------------------------------------------------------------------------------|--|
| Platform Compatibility | Straumann synOcta | |
| Platform Diameter (mm) | RN 4.8 mm, WN 6.5 mm | |
| Dimension of Abutment | Blank Abutment: 13.30 mm long, 9.44 mm diameter | |
| Dimensions of Screw | 8 mm long, M2.0 thread | |
| Connection | Octagonal | |
| Material | Titanium Alloy (ASTM F136) | |
| Design / Construction | Machined | |
| Surface Treatment | None | |
| Abutment Angle | Straight, 0° | |
| Implant Seat | Sits on a Taper | |
| Screw Seat | Sits on a Taper | |

#### E. INDICATIONS FOR USE

Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Inclusive Titanium Abutments are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.

#### F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Inclusive Titanium Abutments, compatible with Straumann Standard Plus Tissue Level Implants, are substantially equivalent to the ITI synOcta Meso Abutments (K033243) and the Inclusive Titanium Abutment Blanks (K083192). They are substantially equivalent in intended use, materials, design, technological characteristics, and performance.

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

Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular graphic on the left, resembling a prism. To the right of the graphic, the word "PRISMATIK" is written in bold, uppercase letters. Below "PRISMATIK", the words "DENTALCRAFT, INC." are written in a smaller font size.

# COMPARISON OF DEVICES

| | PROPOSED | PREDICATE (I) | PREDICATE (II) | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| | Inclusive Titanium<br>Abutments,<br>compatible with<br>Straumann Standard<br>Plus Tissue Level<br>Implants | Inclusive Titanium<br>Abutment Blanks | ITI synOcta Meso<br>Abutments | Similarities<br>/<br>Differences<br>of Devices |
| Manufacturer | Prismatik Dentalcraft | Prismatik Dentalcraft | Straumann USA | - |
| 510(k) Number | K141211 | K083192 | K033243 | - |
| Indications<br>for Use | Inclusive Titanium<br>Abutments are<br>premanufactured<br>prosthetic components<br>directly connected to<br>endosseous dental<br>implants and are<br>intended for use as an<br>aid in prosthetic<br>rehabilitation.<br>Inclusive Titanium<br>Abutments are<br>compatible with<br>Straumann Standard<br>Plus Tissue Level<br>Implants in RN (4.1<br>mm and 4.8 mm) and<br>WN (4.8 mm) sizes. | Inclusive Titanium<br>Abutment Blank is<br>intended to be used<br>in conjunction with<br>endosseous implants<br>in the maxillary<br>and/or mandibular<br>arch to provide<br>support for crowns,<br>bridges or<br>overdenture<br>prostheses. The<br>prosthesis can be<br>cement retained to<br>the abutment. The<br>abutment screw is<br>intended to secure<br>the abutment to the<br>endosseous implant. | Abutments are<br>intended to be placed<br>into dental implants to<br>provide support for<br>prosthetic<br>reconstructions such as<br>crowns or bridges. The<br>ITI synOcta Measo<br>abutments are<br>indicated for cemented<br>restorations in esthetic<br>areas of the mouth. The<br>abutment can be used<br>in single tooth<br>replacements and<br>multiple tooth<br>restorations. | Same<br>Intended<br>Use |
| Platform<br>Compatibility | Straumann synOcta | - | Straumann synOcta | Same |
| Platform<br>Diameter (mm) | RN 4.8 mm<br>WN 6.5 mm | - | RN 4.8 mm<br>WN 6.5 mm | Same |
| Dimensions of<br>Abutment Screw | 8 mm long<br>M2.0 thread | - | 8 mm long<br>M2.0 thread | Same |
| Connection | Octagonal | - | Octagonal | Same |
| Material<br>(Abutment &<br>Screw) | Titanium Alloy<br>(ASTM F136) | Titanium Alloy<br>(ASTM F136) | Abutment: Unalloyed<br>Titanium (ASTM F67)<br>Screw: Titanium Alloy | Same with<br>Predicate I.<br>Similar with<br>Predicate II. |
| Design /<br>Construction | Machined | Machined | Machined | Same |
| Abutment Angle | 0° | 0°-20° | - | Similar |
| Implant Seat | Sits on a Taper | Sits on a Taper | Sits on a Taper | Same |
| Screw Seat | Sits on a Taper | Sits on a Taper | Sits on a Taper | Same |

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

Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.

#### G. SUMMARY OF NON-CLINICAL TESTING/PERFORMANCE DATA

Non-clinical test data was used to evaluate the proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.

Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and it consisted of testing finished assembled implant/abutment systems of the worst case scenario, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.

In addition, sterilization validation information and recommended sterilization method based on ANSI/AAMI ST79 and ISO 17665-1 is provided in the Information for Use.

The testing performed demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.

## CONCLUSION FROM THE NON-CLINICAL TESTING/ PERFORMANCE H. DATA

The results of the nonclinical testing performed, demonstrate that Inclusive Titanium Abutments compatible with Straumann Standard Plus Tissue Level Implants perform as well as the predicate devices. Therefore the proposed device is substantially equivalent with the predicate devices cleared for the same intended use.