INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT

K142115 · Prismatik Dentalcraft, Inc. · NHA · Nov 13, 2014 · Dental

Device Facts

• Record ID: K142115
• Device Name: INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: NHA · Dental
• Decision Date: Nov 13, 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.

Device Story

Inclusive Titanium Abutments are premanufactured prosthetic components used in dental clinics to support prosthetic restorations (crowns, bridges, overdentures). The device is placed over the shoulder of an endosseous dental implant and secured using an abutment screw. Operated by dental professionals, the abutment serves as the interface between the implant and the final prosthesis. By providing a stable connection to the implant, the device facilitates the restoration of dental function and aesthetics for patients. The abutments are machined from titanium alloy and are compatible with specific internal hex or trilobe implant platforms.

Clinical Evidence

Bench testing only. Evidence includes reliability calculations, fatigue testing, and static load failure testing of finished assembled implant/abutment systems in accordance with FDA guidance for root-form endosseous dental implants and abutments. Sterilization validation provided per ANSI/AAMI ST79 and ISO 17665-1.

Technological Characteristics

Material: Titanium grade 23 (Ti-6AL-4V ELI) per ASTM F-136. Design: Machined, premanufactured prosthetic components. Connection: Internal hex or internal trilobe. Dimensions: Compatible with specific Zimmer, Biomet 3i, and Nobel Biocare platforms. Sterilization: Validated method per ANSI/AAMI ST79 and ISO 17665-1.

Indications for Use

Indicated for use as an aid in prosthetic rehabilitation for patients requiring support for crowns, bridges, or overdenture prostheses in the maxillary or mandibular arch, connected to compatible Zimmer Screw-Vent, Biomet 3i Certain, or Nobel Biocare NobelReplace endosseous dental implants.

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 Abutment for Zimmer, 3i and Nobel Biocare Implants (K073217)
• NobelProcera Ti Abutment (K091756)
• BIOMET 3i Dental Abutments and Restorative Components (K072642)
• Zimmer Ti Prepable Abutment (K092403)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

November 13,2014

Prismatik Dentalcraft, INC Brandon Shepard Regulatory Affairs & Ouality Assurance Specialist 2212 Dupont Dr. Suite P Irvine, California 92612

Re: K142115

Trade/Device Name: Inclusive® Titanium Abutments, compatible with Zimmer Screw-Vent, Biomet 3i Certain, and Nobel Biocare NobelReplace Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: October 10, 2014 Received: October 14, 2014

Dear Mr. Shepard:

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 (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 Industry and Consumer Education at its toll-free 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 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,

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

Enclosure

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### Indications for Use

### 510(k) Number: K142115

Device Name: Inclusive® Titanium Abutments, compatible with Zimmer Screw-Vent, Biomet 3i Certain, and Nobel Biocare NobelReplace 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.

Inclusive® Titanium Abutments are compatible with:

- Biomet: 3i Certain internal hex implants in 3.4, 4.1, 5.0, 6.0 mm sizes -Nobel Biocare: NobelReplace straight and tapered internal connection implants in NP, RP, WP, 6.0 mm sizes

- Zimmer: Screw-Vent and Tapered Screw-Vent internal hex implants in 3.5. 4.5. 5.7 mm sizes

Prescription Use 1 (Part 21 CFR 801 Subpart D)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including pink, blue, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a sans-serif font.

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# 10(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 / Fax: | [phone] / [phone] |
| Contact Person: | Primary Contact:<br>• Brandon Shepard, [phone]<br>Secondary Contact:<br>• Marilyn Pourazar, [phone] |
| Date Summary Prepared: | August 1, 2014 |

DEVICE IDENTIFICATION

| Trade/Proprietary Name: | Inclusive ^® Titanium Abutments<br>compatible with: Zimmer Screw-Vent, Biomet 3i<br>Certain, and Nobel Biocare NobelReplace Implants |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 872.3630 |
| Product Code: | NHA |
| Device Class: | 2 |
| Review Panel: | Dental |

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Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a rainbow gradient. To the right of the triangle is the company name, "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. The text is in a blue sans-serif font.

#### C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name:

- · Inclusive 110 Abutment for Zimmer, 3i and Nobel Biocare Implants (K073217)
- · NobelProcera Ti Abutment (K091756)
- · BIOMET 3i Dental Abutments and Restorative Components (K072642)
- · Zimmer Ti Prepable Abutment (K092403).

#### 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 fastened into the implant with a screw. Abutments are made of titanium grade 23 (Ti-6AL-4V ELI) and meet ASTM F-136 Standard.

#### 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:

- Biomet: 3i Certain internal hex implants in 3.4, 4.1, 5.0, 6.0 mm sizes -
- -Nobel Biocare: NobelReplace straight and tapered internal connection implants in NP, RP, WP, 6.0 mm sizes
- -Zimmer: Screw-Vent and Tapered Screw-Vent internal hex implants in 3.5, 4.5, 5.7 mm sizes

#### NON-CLINICAL TESTING F.

Non-clinical test data was used to evaluate the device's safety and effectiveness, and determine substantial equivalence with predicate devices.

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 Reliability Calculation, Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems.

In addition, sterilization validation information and a 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 established that the predicate device is as safe, as effective, and performs as well as the predicate device(s).

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Image /page/5/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 sections of different colors, including pink, purple, blue, green, and yellow. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

#### SUBSTANTIAL EQUIVALENCE G.

Inclusive® Titanium Abutments, compatible with Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants are substantially equivalent to the Inclusive™ Abutment for Zimmer, 3i and Nobel Biocare Implants (K073217) and the OEM predicates, (K091756, K072642, and K092403), identified in Section C above. They are substantially equivalent in intended use, materials, design and performance.

(See Comparison Tables below).

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Image /page/6/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 sections with different colors, including pink, purple, blue, and yellow. The company name is written in a sans-serif font, with "PRISMATIK" on the first line and "DENTALCRAFT, INC." on the second line.

| | Predicate Device (1) | Predicate Device (2) | Proposed Device | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Ti Prepable Abutment<br>(K092403) | Inclusive Abutment for<br>Zimmer, 3i, and Nobel Biocare<br>Implants (K073217) | Inclusive Titanium<br>Abutments compatible<br>with: NobelReplace<br>Implants | Similarities and<br>Differences |
| Manufacturer | Zimmer Dental | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A |
| Dimensions of<br>Abutment | Hex Dimensions:<br>2.4mm Across Flats<br>3.0mm Across Flats | Cylindrical Diameter: 9.4mm<br>Hex Dimensions:<br>2.4mm Across Flats<br>3.0mm Across Flats | Cylindrical Diameter: 9.4mm<br>Hex Dimensions:<br>2.4mm Across Flats<br>3.0mm Across Flats | Same |
| Abutment Screw<br>Manufacturer | OEM (Zimmer) | OEM (Zimmer) | Inclusive (Prismatik) | Equivalent screw<br>from different<br>manufacturer |
| Dimensions of<br>Abutment Screw | Length 8.2mm; 1-72 UNF-2A<br>Thread | Length 8.2mm; 1-72 UNF-2A<br>Thread | Length 8.2mm; 1-72 UNF-2A<br>Thread | Same |
| Indications for Use | The Ti Prepable Abutments are<br>designed for use as a terminal or<br>intermediate abutment for cement<br>retained prosthesis. It allows for<br>preparation for the crown to be<br>attached. It can be used for a<br>single or multiple-unit restoration.<br>The abutment is intended to be<br>prepared and placed with patient<br>specific margins. | The Inclusive Abutment is<br>intended to be used in<br>conjunction with endosseous<br>implants in the maxillary and/or<br>mandibular arch to provide<br>support for crowns, bridges or<br>overdenture prostheses. The<br>prosthesis can be cement<br>retained to the abutment. The<br>abutment screw is intended to<br>secure the abutment to the<br>endosseous implant. | Inclusive Titanium<br>Abutments are<br>premanufactured prosthetic<br>components directly<br>connected to endosseous<br>dental implants and are<br>intended for use as an aid in<br>prosthetic rehabilitation. | Same Intended<br>Use. Different<br>wording in the<br>Indications for<br>Use |
| Platform<br>Compatibility | Zimmer Dental Screw-Vent<br>3.5, 4.5, 5.7mm | Zimmer Dental Screw-Vent<br>3.5, 4.5, 5.7mm | Zimmer Dental Screw-Vent<br>3.5, 4.5, 5.7mm | Same |
| Connection | Internal Hex | Internal Hex | Internal Hex | Same |
| Design/Construction | Machined | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0° | 0°-20° | 0°-30° | Similar; increased<br>angulation range |
| Implant Seat | Flat | Flat | Flat | Same |
| Screw Seat | Flat | Flat | Flat | Same |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Same |
| | Predicate Device (1) | Predicate Device (2) | Proposed Device | |
| | Biomet 3i Dental Abutments &<br>Restorative Components (K072642) | Inclusive Abutment for<br>Zimmer, 3i, and Nobel Biocare<br>Implants (K073217) | Inclusive Titanium<br>Abutments compatible with:<br>Biomet 3i Certain Implants | Similarities and<br>Differences |
| Manufacturer | Biomet | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A |
| Dimensions of<br>Abutment | Hex Dimensions:<br>2.2mm Across Flats<br>2.7mm Across Flats | Cylindrical Diameter: 9.4mm<br>Hex Dimensions:<br>2.2mm Across Flats<br>2.7mm Across Flats | Cylindrical Diameter: 9.4mm<br>Hex Dimensions:<br>2.2mm Across Flats<br>2.7mm Across Flats | Same |
| Abutment Screw<br>Manufacturer | OEM (Biomet 3i) | OEM (Biomet 3i) | Inclusive (Prismatik) | Equivalent screw<br>from different<br>manufacturer |
| Dimensions of<br>Abutment Screw | Length: 8.4mm; M1.6 Thread | Length: 8.4mm; M1.6 Thread | Length: 8.4mm; M1.6 Thread | Same |
| Indications for Use | Biomet 3i Dental Abutments are<br>intended for use as accessories to<br>endosseous dental implant to support<br>a prosthetic device in a partially or<br>completely edentulous patient. A<br>dental abutment is intended for use to<br>support single and multiple tooth<br>prosthesis, in the mandible or maxilla.<br>The prosthesis can be screw retained<br>or cement retained. | The Inclusive Abutment is<br>intended to be used in<br>conjunction with endosseous<br>implants in the maxillary and/or<br>mandibular arch to provide<br>support for crowns, bridges or<br>overdenture prostheses. The<br>prosthesis can be cement<br>retained to the abutment. The<br>abutment screw is intended to<br>secure the abutment to the<br>endosseous implant. | Inclusive Titanium Abutments<br>are premanufactured prosthetic<br>components directly connected<br>to endosseous dental implants<br>and are intended for use as an<br>aid in prosthetic rehabilitation. | Same Intended<br>Use. Different<br>Indications for<br>Use statement. |
| Platform<br>Compatibility | Biomet 3i Certain<br>3.4, 4.1, 5.0, 6.0mm | Biomet 3i Certain<br>3.4, 4.1, 5.0, 6.0mm | Biomet 3i Certain<br>3.4, 4.1, 5.0, 6.0mm | Same |
| Connection | Internal Hex | Internal Hex | Internal Hex | Same |
| Design/Construction | Machined | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-15° | 0°-20° | 0°-30° | Similar; increased<br>angulation range |
| Implant Seat | Flat | Flat | Flat | Same |
| Screw Seat | Flat | Flat | Flat | Same |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Same |
| | Predicate Device (1) | Predicate Device (2) | Proposed Device | |
| | NobelProcera Ti Abutment<br>(K091756) | Inclusive Abutment for<br>Zimmer, 3i, and Nobel<br>Biocare Implants<br>(K073217) | Inclusive Titanium<br>Abutments compatible<br>with: Nobel Biocare<br>NobelReplace Implants | Similarities and<br>Differences |
| Manufacturer | Nobel Biocare | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A |
| Dimensions of<br>Abutment | Connection Length: 2.9mm | Cylindrical Diameter: 9.4mm<br>Connection Length: 2.9mm | Cylindrical Diameter: 9.4mm<br>Connection Length: 2.9mm | Same |
| Abutment Screw<br>Manufacturer | OEM (Nobel Biocare) | OEM (Nobel Biocare) | Inclusive (Prismatik) | Equivalent screw from<br>different manufacturer |
| Dimensions of<br>Abutment Screw | Length 8.3mm; M1.8 Thread | Length 8.3mm; M1.8 Thread | Length 8.3mm; M1.8 Thread | Same |
| Indications for Use | The NobelProcera Ti<br>Abutments are<br>premanufactured prosthetic<br>components directly connected<br>to endosseous dental implants<br>and are intended for use as an<br>aid in prosthetic rehabilitation. | The Inclusive Abutment is<br>intended to be used in<br>conjunction with endosseous<br>implants in the maxillary<br>and/or mandibular arch to<br>provide support for crowns,<br>bridges or overdenture<br>prostheses. The prosthesis can<br>be cement retained to the<br>abutment. The abutment<br>screw is intended to secure the<br>abutment to the endosseous<br>implant. | Inclusive Titanium<br>Abutments are<br>premanufactured prosthetic<br>components directly<br>connected to endosseous<br>dental implants and are<br>intended for use as an aid in<br>prosthetic rehabilitation. | Same Intended Use.<br>Different Indications<br>for Use statement. |
| Platform<br>Compatibility | Nobel Biocare NobelReplace<br>NP, RP, WP, 6.0 | Nobel Biocare NobelReplace<br>NP, RP, WP, 6.0 | Nobel Biocare NobelReplace<br>NP, RP, WP, 6.0 | Same |
| Connection | Internal Trilobe | Internal Trilobe | Internal Trilobe | Same |
| Design/Construction | Machined | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-30° | 0°-20° | 0°-30° | Similar; increased<br>angulation range |
| Implant Seat | Flat | Flat | Flat | Same |
| Screw Seat | Flat | Flat | Flat | Same |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Same |

## Comparison of Predicate and Proposed Devices: Zimmer Screw-Vent Platform

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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. The text "PRISMATIK DENTALCRAFT, INC." is on the right in a blue sans-serif font.

## Comparison of Predicate and Proposed Devices: Biomet 3i Certain Platform

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Image /page/8/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangular prism on the left and the company name on the right. The prism is made up of various colors, including pink, purple, blue, and green. The company name is written in a sans-serif font.

## Comparison of Predicate and Proposed Devices: Nobel Biocare NobelReplace Platform