Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System

K151798 · Prismatik Dentalcraft, Inc. · NHA · Nov 16, 2015 · Dental

Device Facts

• Record ID: K151798
• Device Name: Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: NHA · Dental
• Decision Date: Nov 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Inclusive® Titanium Abutments are premanufactured prosthetic components; they connect to endosseous dental implants to support prosthetic restorations (crowns/bridges). Used in dental laboratories; technicians modify stock abutments using hand tools to achieve desired shape before clinical placement. Abutments mount to implants via screws. Device provides structural support for dental prosthetics; benefits patient by enabling functional tooth replacement. Used in oral cavity; operated by dental professionals.

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.

Technological Characteristics

Material: Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136. Design: Machined, stock-type abutment with octagonal connection; non-sterile. Dimensions: 9.4mm cylindrical diameter; RN (4.8mm) and WN (6.5mm) sizes. Mechanical fixation via screw.

Indications for Use

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

• Inclusive® Titanium Abutments compatible with: Straumann Tissue Level Implants (K141211)

Reference Devices

• Inclusive Titanium Abutments for NobelActive, Straumann Bone Level, Branemark (K142118)
• ITI synOcta Meso Abutments (K033243)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, with the top profile being the most prominent and the bottom profile being the least prominent. The seal is black and white.

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

November 16, 2015

PRISMATIK DENTALCRAFT, INC. Mr. Armin Zehtabchi Senior RA 2212 Dupont Drive, Suite P Irvine, California 92612

Re: K151798

> Trade/Device Name: Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2015 Received: October 16, 2015

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

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang

for 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

Enclosure

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

# Indications for Use

510(k) Number (if known) K151798

Device Name

Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System

Indications for Use (Describe)

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

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

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> Prescription Use (Part 21 CER 801 Subpart D)</span> |
|-------------------------------------------------------------------------------------------|
| 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 [e-mail]

"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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a rainbow color scheme. To the right of the triangle is the company name in blue text. The text is stacked, with "PRISMATIK" on top, "DENTALCRAFT" in the middle, and ", INC." on the bottom.

B.

## 006_510 (K)-K151798 Summary-807.92(c)

This 510 (k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92.

### SUBMITTER INFORMATION A.

| Company Name: | Prismatik Dentalcraft, Inc. |
|-------------------------------|------------------------------------------------------------------------------------|
| Company Address: | 2212 Dupont Dr., Suite P,<br>Irvine, CA 92612 |
| Company Phone: | 949-225-1269 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 3005477956 |
| Primary Contact Person: | Armin Zehtabchi, [phone]<br>Senior RA Specialist |
| Secondary Contact Person: | Marilyn Pourazar, [phone]<br>Senior Director, RA/QA |
| Date Summary Prepared: | November 16, 2015 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Inclusive® Titanium Abutments compatible<br>with: Straumann synOcta Implant System |
| 21 CFR Reference: | 21 CFR 872.3630 |
| 21 CFR Common Name: | Abutment, implant, dental, endosseous |
| Classification: | Class II, NHA |
| Panel: | Dental |

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

Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a color gradient. The colors in the triangle range from blue to pink to yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font.

#### C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name: Primary Predicate Device: Inclusive® Titanium Abutments compatible with: Straumann Tissue Level Implants, (K141211)

> Reference Device 1: Inclusive Titanium Abutments for NobelActive, Straumann Bone Level, Branemark, (K142118)

Reference Device 2: ITI synOcta Meso Abutments, (K033243)

#### D. PROPOSED 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.

Prismatik Dentalcraft. Inc. provides premanufactured titanium abutments of a stock type with no inherent angulation which require further modification to obtain the desired shape before being used. The modifications are intended to be performed by dental laboratories with laboratory hand tools, as delineated in the device's instructions for use.

#### 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.

They are compatible with Straumann Standard Plus Tissue Level Implants in RN (implant diameter: 4.1 mm and 4.8 mm) and WN (implant diameter: 4.8 mm) sizes.

#### F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The comparison table below outlines and provides the similarities and the substantial equivalency of the Primary Predicate Device, the Inclusive® Titanium Abutments for Straumann Tissue Level Implants, K141211 (cleared by FDA on 10/22/2014), the Reference Device 1, the Inclusive Titanium Abutments for NobelActive, Straumann Bone Level, Branemark, (K142118), the Reference Device 2, the ITI synOcta Meso Abutments, (K033243) and the proposed device, the Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant

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

Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a gradient of colors, including pink, red, yellow, green, blue, and purple. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. The text is stacked, with "PRISMATIK" on the top line, "DENTALCRAFT, INC." on the bottom line.

System. The platform diameters and connection are the same for the Proposed Device and the Reference Device 2 (K033243). The connection for the Proposed Device and the Primary Predicate Device (K141211) is also the same.

Prismatik believes that the comparative data presented in the preceding paragraphs demonstrate that proposed device, Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System is substantially equivalent to currently marketed devices for the same indications for use, and supports our claim of substantial equivalence to predicate Class II devices under the classification of abutment, implant, dental, endosseous (21 CFR 872.3630) that have previously been found to be substantially equivalent. Any differences between the proposed device, the Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System, and the predicate device do not introduce any new issues of safety or effectiveness.

(See Comparison Table below)

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

Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font and is blue.

| Attributes | Primary Predicate Device | Reference Device (1) | Reference Device (2) | Proposed Device | Similarities /<br>Differences |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| | Inclusive Titanium<br>Abutments compatible with:<br>Straumann Tissue Level<br>Implants (K141211) | Inclusive Titanium<br>Abutments<br>compatible with:<br>Straumann Bone<br>Level Implants (K142118) | ITI synOcta Meso Abutments<br>(K033243) | Inclusive® Titanium<br>Abutments compatible with:<br>Straumann Tissue Level<br>synOcta Implant System | |
| | (Prismatik Dentalcraft, Inc.) | (Prismatik Dentalcraft, Inc.) | Straumann USA | (Prismatik Dentalcraft, Inc.) | |
| Indications<br>for Use | Inclusive Titanium Abutments<br>are pre-manufactured<br>prosthetic components directly<br>connected to endosseous<br>dental implants and are<br>intended for use as an aid to<br>prosthetic rehabilitation.<br>Inclusive Titanium Abutments<br>are compatible with<br>Straumann Standard<br>Plus Tissue Level Implants in<br>RN (4.1 mm and 4.8 mm) and<br>WN (4.8<br>mm) sizes. | Inclusive Titanium<br>Abutments are<br>premanufactured prosthetic<br>components<br>directly connected to<br>endosseous dental<br>implants and are intended<br>for use as an<br>aid in prosthetic<br>rehabilitation.<br>Inclusive® Titanium<br>Abutments are compatible<br>with:<br>- Straumann: Bone Level<br>NC and RC implant sizes<br>- Nobel Biocare: Branemark<br>RP size implant<br>- Nobel Biocare<br>NobelActive NP and RP<br>internal connection implants | Abutments are intended to be<br>placed into dental implants to<br>provide support for prosthetic<br>reconstructions such as crowns or<br>bridges. The ITI synOcta Meso<br>abutments are indicated for<br>cemented restorations in esthetic<br>areas of the mouth. The abutment<br>can be used in single tooth<br>replacements and multiple tooth<br>restorations. | Inclusive Titanium Abutments<br>are pre-manufactured prosthetic<br>components directly connected<br>to endosseous dental implants<br>and are intended for use as an<br>aid to prosthetic rehabilitation.<br>They are compatible with<br>Straumann Standard Plus<br>Tissue Level Implants in RN<br>(implant diameter: 4.1 mm and<br>4.8 mm) and WN (implant<br>diameter: 4.8 mm) sizes. | Same as<br>primary<br>predicate |
| Attributes | Primary Predicate Device | Reference Device (1) | Reference Device (2) | Proposed Device | Similarities /<br>Differences |
| | Inclusive Titanium<br>Abutments compatible with:<br>Straumann Tissue Level<br>Implants (K141211) | Inclusive Titanium<br>Abutments<br>compatible with:<br>Straumann Bone<br>Level Implants (K142118) | ITI synOcta Meso Abutments<br>(K033243) | Inclusive® Titanium<br>Abutments compatible with:<br>Straumann Tissue Level<br>synOcta Implant System | |
| Dimensions | Cylindrical Diameter: 9.4mm<br>RN: diameter 4.8mm;<br><br>WN: diameter 6.5mm | Cylindrical Diameter:<br>9.4mm Connection Length:<br>2.735mm | synOcta RN 4.8 mm<br><br>synOcta WN 6.5 mm | Cylindrical Diameter: 9.4mm<br>RN: diameter 4.8mm;<br><br>WN: diameter 6.5mm | Same as<br>Primary<br>Predicate<br>Device and<br>Reference<br>Device # 2 |
| Connection | Octagonal | Slot | Octagonal | Octagonal | Same as<br>Primary<br>Predicate<br>Device and<br>Reference<br>Device # 2 |
| Sterility | Packaged Non-sterile | Packaged Non-sterile | Packaged Non-sterile | Packaged Non-sterile | Same |
| Material | Titanium Alloy, Grade 23 | Titanium Alloy, Grade 24 | Ti-6AL-7Nb | Titanium Alloy, Grade 23 | Same |
| Picture of<br>Abutment | Image: abutment | Image: abutment | Image: abutment | Image: abutment | - |
| Attributes | Primary Predicate Device | Reference Device (1) | Reference Device (2) | Proposed Device | Similarities /<br>Differences |
| | Inclusive Titanium<br>Abutments compatible with:<br>Straumann Tissue Level<br>Implants (K141211) | Inclusive Titanium<br>Abutments<br>compatible with:<br>Straumann Bone<br>Level Implants (K142118) | ITI synOcta Meso Abutments<br>(K033243) | Inclusive® Titanium<br>Abutments compatible with:<br>Straumann Tissue Level<br>synOcta Implant System | |
| Picture of<br>Screw | Image: Primary Predicate Device Screw | Image: Reference Device (1) Screw | Image: Reference Device (2) Screw | Image: Proposed Device Screw | - |
| Abutment<br>Angle | None | 0°-30° | - | 0°-30° | Same as the<br>Reference<br>Device 1 |
| Abutment<br>Seat | Sits on a taper | 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 | Sits on a taper | Same |
| Anatomical<br>Site | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Same |
| Construction | Machined | Machined | Machined | Machined | Same |

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

Image /page/7/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color gradient, transitioning from blue to pink. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", written in a blue sans-serif font. The logo is clean and professional, suggesting a modern and innovative dental company.

#### SUMMARY OF NON-CLINICAL TESTING (PERFORMANCE DATA) G.

Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device.

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.

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

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

The proposed device, the Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System has the same performance specifications, fundamental scientific technology and intended use as that of the Prismatik's Primary Predicate device, the Inclusive® Titanium Abutments compatible with: Straumann Tissue Level Implants, K141211 (cleared by FDA on 10/22/2014), the Reference Device 1, the Inclusive Titanium Abutments for NobelActive, Straumann Bone Level, Branemark, K142118 (cleared by FDA on 11/25/2014) and the Reference Device 2, the ITI synOcta Meso Abutments, (K033243). These devices are substantially equivalent, and that any differences between the proposed device, the Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System and the cited primary predicate and reference devices do not introduce any new issues or concerns.