What is the regulatory pathway for Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System

Q: Who is the manufacturer of Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System?

Prismatik Dentalcraft, Inc. filed the 510(k) submission for Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System (K170044).

Q: What is the FDA product code for Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

K170044 · Prismatik Dentalcraft, Inc. · NHA · Jun 6, 2017 · Dental

Device Facts

Record ID	K170044
Device Name	Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
Applicant	Prismatik Dentalcraft, Inc.
Product Code	NHA · Dental
Decision Date	Jun 6, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Device Story

Inclusive® Titanium Abutments are premanufactured prosthetic components for endosseous dental implants. Clinicians prescribe patient-specific abutments, which are digitally designed and manufactured at a Prismatik Dentalcraft validated milling center using CAD/CAM technology. The device serves as an interface between the implant and the final prosthetic restoration (crowns, bridges, or copings). The abutments are made of Ti-6Al-4V ELI titanium alloy. The system is used in dental clinics by clinicians to support prosthetic rehabilitation. The output is a custom-milled abutment that provides structural support for the final restoration, potentially improving patient chewing function and aesthetic outcomes.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including fatigue testing and static load failure testing per ISO 14801:2007, and reverse engineering analysis.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F-136). Design: Prefabricated, machined titanium interface for CAD/CAM fabrication. Connectivity: Compatible with MegaGen AnyRidge implant system (3.5-8.4mm diameters). Sterilization: Multi-unit abutments gamma-sterilized (min 25kGy, SAL 10^-6); others provided non-sterile for clinician-validated sterilization per ANSI/AAMI ST79/ISO 17665-1.

Indications for Use

Indicated for patients with edentulous or partially edentulous maxilla or mandible requiring support for cement-retained or screw-retained prosthetic restorations via 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 Abutments (K160979)

Reference Devices

Inclusive® Titanium Abutments for Astra OsseoSpeed Implants (K100993)
XPEED AnyRidge Internal Implant System (K140091)
Hahn Tapered Implant System (K143353)
Inclusive Tapered Implant System (K121406)
Shofu MonoCem Resin Cement (K020481)

Related Devices

K191222 — Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV · Prismatik Dentalcraft, Inc. · Aug 5, 2019
K223496 — Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems · Prismatik Dentalcraft, Inc. · Sep 26, 2023
K202269 — PRE-MILLED Abutment · Mit Global Co., Ltd. · Nov 25, 2020
K241616 — ALLONUS Tech Prosthetics · Allonus Tech Co., Ltd. · Dec 17, 2024
K162734 — CreoDent Solidex Customized Abutment · Creodent Prosthetics, Ltd. · May 8, 2017

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 6, 2017 Prismatik Dentalcraft, Inc. Maria Wagner Sr. Specialist, Regulatory Affairs 2212 Dupont Dr., Suite P Irvine, California 92612 Re: K170044 Trade/Device Name: Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 8. 2017 Received: May 10, 2017 Dear Maria Wagner: 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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Tina Kiang -S 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) K170044 Device Name Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System Indications for Use (Describe) Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations. All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture. Compatible Implant System: MegaGen AnyRidge® Implant System Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5 and 5.0 | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors. To the right of the prism is the company name in blue text. # 007_510(k) 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. # A. SUBMITTER INFORMATION B. Panel: | Company Name: | Prismatik Dentalcraft, Inc. | |-------------------------------|-----------------------------------------------------------------------------------| | Company Address: | 2212 Dupont Dr., Suite P, Irvine, CA 92612 | | Company Phone: | 949-440-2636 | | Company FAX: | (978) 313-0850 | | Facility Registration Number: | 2031503 | | Primary Contact Person: | Maria E. Wagner, (949) 440-2636 Senior Specialist, Regulatory Affairs | | Secondary Contact Person | Shelly Harris, (949) 440-2631 Director, RA/QA | | Date Summary Prepared: | June 05, 2017 | | DEVICE IDENTIFICATION | | | Trade/Proprietary Name: | Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System | | 21 CFR Reference: | 21 CFR 872.3630 | | 21 CFR Common Name: | Endosseous dental Implant Abutment | | Classification: | Class II, NHA | # C. IDENTIFICATION OF PREDICATE DEVICE | Primary Predicate: | Inclusive Abutments (K160979) | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Reference Device: | Inclusive® Titanium Abutments for Astra OsseoSpeed Implants (K100993) XPEED AnyRidge Internal Implant System (K140091) Hahn Tapered Implant System (K143353) Inclusive Tapered Implant System (K121406) Shofu MonoCem Resin Cement (K020481) | Dental {4}------------------------------------------------ Image /page/4/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 blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. #### PROPOSED DEVICE DESCRIPTION D. Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System are made of titanium alloy and have a prefabricated, precision interface (implant/ abutment connection) and are to be used for fabrication of patientspecific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by a Prismatik Dentalcraft authorized milling center. The proposed device is compatible with the MegaGen AnyRidge Implant System (K140091); 3.5, 4.0. 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4mm implant diameter. Abutments are made from alloyed titanium Ti-6Al-4V ELI which meets ASTM standard F-136. The Titanium Abutment Blanks are used for fabrication of all-titanium patientspecific abutments. These abutments include Multi-unit, Esthetic, and Straight Abutments. The Straight Abutments come in both Engaging and Non-Engaging connections. The Straight abutments 4.5 mm and 6.0 mm are used for support of CAD/CAM fabricated crowns / bridges or CAD/CAM fabricated zirconia copings. A patient-specific finished device for the 4.5 mm and 6.0 mm straight abutments will consist of both the titanium base and zirconia coping and will contain no angle correction. #### ட். INDICATIONS FOR USE Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screwretained prosthetic restorations. All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture. Compatible Implant System: MegaGen AnvRidge® Implant System Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5, 5.0. #### ட் DETERMINATION OF SUBSTANTIAL EQUIVALENCE Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System are substantially equivalent to the Titanium Abutments used in the MegaGen AnyRidge Implant System identified in Section C above. This includes the Multi-unit, Esthetic, Engaging and Non-Engaging Abutments. They are substantially equivalent in intended use, materials, design and performance. Provided below is Table 1 which provides a comparison between the predicate, referenced and proposed devices. Table 3 also provide additional referenced device with our CAD/CAM submission. Inclusive® Titanium (Multi-unit, Esthetic, Engaging and Non-Engaging), Abutments are fabricated to be compatible with the predicate device connection. {5}------------------------------------------------ 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 several sections, each with a different color. The company name is written in a sans-serif font. They are substantially equivalent in intended use, materials, design and performance with the reference predicates as depicted in Table 2 and 2A below (2A is specific to 4.5 mm and 6.0mm). The differences between the predicate and proposed devices have been evaluated per the testing described in section G (non-clinical testing) and the proposed device is substantially equivalent to the predicate (See Comparison Tables 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. # Table 1 – Comparison between Predicate and Proposed Device | Attributes | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | Proposed Device | Similarities and Differences | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Inclusive Abutments | Xpeed AnyRidge Implant System | Inclusive Titanium Abutments for AstraTech OsseoSpeed Implants | Hahn Tapered Implant System | Inclusive Tapered Implant System | Inclusive Titanium Abutments compatible with: MeqaGen AnyRidge Implant System | N/A | | 510(k) number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A | | Manufacturer: | Prismatik Dentalcraft Inc. | Megagen Implant Co., Ltd. | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A | | Indications for Use | Inclusive Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement- retained or screw-retained | The Xpeed AnyRidge® Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and | Inclusive Titanium Abutments for Astra OsseoSpeed Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. | Hahn Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability | Inclusive Tapered Implant System is indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in | Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement- retained or | The indications for use is the same as our primary predicate. The only difference is the implant compatibility to the Ref. Device (K140091). | | Attributes | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | Proposed Device | Similarities and Differences | | | Inclusive Abutments | Xpeed AnyRidge Implant System | Inclusive Titanium Abutments for AstraTech OsseoSpeed Implants | Hahn Tapered Implant System | Inclusive Tapered Implant System | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | N/A | | 510(k) number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A | | | prosthetic restorations. All digitally designed abutments for use with Inclusive® Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture | overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar | They are compatible with the Astra Tech OsseoSpeed 3.0, 3.5, 4.0, 4.5, 5.0 implants. | and appropriate occlusal loading. | the presence of primary stability and appropriate occlusal loading. | screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture. Compatible Implant System: MegaGen AnyRidge® | | | Attributes | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | Proposed Device | Similarities and Differences | | | Inclusive Abutments | Xpeed AnyRidge Implant System | Inclusive Titanium Abutments for AstraTech OsseoSpeed Implants | Hahn Tapered Implant System | Inclusive Tapered Implant System | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | N/A | | 510(k) number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A | | Platform Compatibility | 3.0-7.0mm | K140091 region and are indicated for delayed loading. | Implant diameters: 3.0, 3.5, 4.0, 4.5, 5.0mm | 3.0, 3.5, 4.3, 5.0 and 7.0mm | 3.7, 4.7, and 5.2mm | Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5 and 5.0 Implant Diameters: 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4mm | Same as reference device | | Connection | Hexagon | Hexagon | Hexagon | Hexagon | Hexagon | Hexagon | Same | | Material | Ti-6Al-4V ELI | CP Ti Grade 4 | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Same as predicate | | Design/Construction | Machined | Machined | Machined | Machined | Machined | Machined | Same | | Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Same | | Implant Seat | Sits on a Taper | Sits on a Taper | Sits on a Taper | Sits on a Taper | Sits on a Taper | Sits on a Taper | Same | | Screw Seat | Sits on a Flat | Sits on a Flat | Sits on a Flat | Sits on a Flat | Sits on a Flat | Sits on a Flat | Same | | Attributes | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | Proposed Device | Similarities and Differences | | | Inclusive Abutments | Xpeed AnyRidge Implant System | Inclusive Titanium Abutments for AstraTech OsseoSpeed Implants | Hahn Tapered Implant System | Inclusive Tapered Implant System | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | N/A | | 510(k) number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A | | Conclusion: | The comparison above outline the similarities between the predicate and proposed devices. Prismatik has presented comparative data in the preceding paragraphs that demonstrate that Inclusive® Titanium Abutments are substantially equivalent to the predicate device. Any differences between the proposed device and the predicate device do not introduce any new concerns of safety and effectiveness. | | | | | | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains 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 divided into sections with different colors, including pink, magenta, blue, and green. The company name is written in a sans-serif font, with "PRISMATIK" on the first line and "DENTALCRAFT, INC." on the second line. {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 smaller triangles, each with a different color. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. {9}------------------------------------------------ Image /page/9/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, red, yellow, green, and blue. The company name is written in a sans-serif font, with "PRISMATIK" on the first line and "DENTALCRAFT, INC." on the second line. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. The colors are arranged in a circular pattern, with blue at the bottom, green on the right, and pink at the top. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue. | Table 2 Comparison of variation of Abutments (Multi-Unit, Esthetic, Engaging and Non-Engaging) | | | | | | | | |------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------| | Attributes | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | Proposed Device | Similarities and Differences | | | Inclusive Abutments | Xpeed AnyRidge Implant System | Inclusive Titanium Abutments for AstraTech OsseoSpeed Implants | Hahn Tapered Implant System | Inclusive Tapered Implant System | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | | | 510(k) Number | K160979 | K140091 | K100993 | K143353 | K121406 | K170044 | N/A | | Multi-Unit Abutments | Multi-Unit Abutments are provided in 0°, 17°, or 30° configurations | N/A | N/A | Multi-Unit Abutments are provided in 0°, 17°, or 30° configurations | N/A | Multi-Unit Abutments are provided in 0°, 17°, or 30° configurations | Same as Hahn Tapered Implant (reference K143353) | | Esthetic Abutments | N/A | Angled Abutment | N/A | N/A | N/A | Angled Abutment | Same as Reference (K140091) | | 4.5mm Non- Engaging Abutments | 4.5 mmH abutments have a 4 mm post height | N/A | N/A | N/A | N/A | 4.5 mmH abutments have a 4 mm post height | Same as predicate (K160979) | | 4.5/6.0mm Engaging Abutments | 4.5/6 mmH abutments have a 4 mm or 5.5 mm post heights | N/A | N/A | N/A | N/A | 4.5/6 mmH abutments have a 4 mm or 5.5 mm post heights | Same as predicate (K160979) | The Multi-Unit, Esthetic, and Engaging abutment connetries are hexagon shaped and there is no connection geometry for the nonengaging. Please note the 4.5 and 6.0 mm are for straight abutments only. The materials for all variations of abutments are the same, Ti-6AI-4V ELI. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors. To the right of the prism is the company name in blue text. ## Table 2A: Design Parameters (4.5 mm and 6.0 mm) The subject device is substantially equivalent in indications and design principles to predicate devices shown above. Below is a summary table comparing the subject device, the primary predicate device and the additional reference predicate device. | | Subject Device | Primary Predicate Device | |-------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------| | Comparison | Prismatik Dentalcraft, Inc. (K170044) | Inclusive Abutments (K160979) | | Design | | | | Abutment Design | Titanium Blank for CAD/CAM Titanium Abutment for CAD/CAM | Titanium Blank for CAD/CAM Titanium Abutment for CAD/CAM | | Prosthesis Attachment | Cement-retained Screw retained | Cement-retained Screw retained | | Restoration | Single-unit Multi-unit | Single-unit Multi-unit | | Abutment Platform Diameter | 3.5 - 8.4mm | 3.0-7.0mm | | Abutment Angle | Straight only | Straight only | | Material | | | | Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | | Coping | Y-TZP | Y-TZP | | Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Please note the 4.5 and 6.0 mm are for straight abutments only. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image contains the logo for PRISMATIK DENTALCRAFT, INC. On the left side of the logo is a triangular shape with a gradient of colors, including pink, blue, yellow, and green. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", written in blue font. The logo is simple and professional, and the use of color in the triangle adds a touch of creativity. #### NON-CLINICAL TESTING (PERFORMANCE DATA) G. The technological characteristics of the subject device have been verified to be essentially the same as the predicate device based on assessments of material composition, dimensional features, and mechanical properties. Non-clinical test data was used to 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". ## Summary of Testing: The technological characteristics of the Inclusive Titanium Abutments compatible with MegaGen AnyRidge Implant System have been verified to be essentially the same as the predicate devices based on assessments of materials composition, dimensional features, mechanical properties and biocompatibility of the implant and instrument materials. Comparative testing was performed to show equivalence to the predicate device. This testing was performed according to ISO 14801:2007. This consisted of Reliability Calculation, Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems. Reverse engineering analysis of critical features was performed on OEM implant bodies, OEM abutments, and OEM abutment fixation screws to establish compatibility. The proposed device is made of the same material (medical grade titanium) as indicated in our reference devices K121406 and K143353. All the applicable Biocompatibility testing (Sensitization, Cytotoxicity, and Systemic Toxicity) has been conducted for these Devices. Hence, no additional biocompatibility testing was deemed necessary for this submission. ## Sterile Product: The Inclusive® Multi-Unit Abutments are provided sterilized via a minimum of 25KGy dose of gamma radiation to ensure SAL 10°. The sterilization dose was determined using the Method VDmax25 Dose Audit in accordance with ANSI/AAMI/ISO 11137-2:2013 Sterilization of Health Care Products - Radiation -Part 2: Establishing the Sterilization Dose. ## Non-Sterile Product Inclusive® Titanium Abutments compatible with: MegaGen and abutment screws are single-use devices, and are being shipped non-sterile, as they require further modification. After modification, and prior to clinical use, dental abutments and screws must be cleaned, disinfected, and sterilized according to a validated method, as described in the IFU. The recommended sterilization validation method is based on ANSI/AAMI ST79 and ISO 17665-1 and is provided in the reference predicates K160979 and K143353. No clinical test data was used to support the decision of substantial equivalence. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors. To the right of the prism is the company name in blue text. # Conclusion: In accordance with Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notifications the Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System is substantially equivalent to the predicate devices as described.