Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments

Q: Who is the manufacturer of Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments?

Medentika GmbH filed the 510(k) submission for Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments (K223113).

Q: What is the FDA product code for Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments?

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

Q: What is the regulatory pathway for Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments?

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

Q: What are the predicate devices for Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments?

Medentika Abutment System (K142167).

Q: Who can help prepare an FDA 510(k) submission like Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments?

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.

K223113 · Medentika GmbH · NHA · Apr 15, 2024 · Dental

Device Facts

Record ID	K223113
Device Name	Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
Applicant	Medentika GmbH
Product Code	NHA · Dental
Decision Date	Apr 15, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center. Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment. Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

Device Story

Medentika Abutment System comprises titanium abutments, screws, caps, and bases designed to interface with various OEM dental implant systems; supports single-unit or multi-unit (bridge/bar) prostheses. CAD/CAM variants (TiBases, PreFace) integrate with Straumann CARES System for digital design and milling of patient-matched superstructures (zirconia). Used in dental clinics by clinicians; components are either cement-retained or screw-retained. Provides stable mechanical connection between implant and final restoration; facilitates functional and aesthetic tooth replacement. Benefits patient by restoring masticatory function and oral aesthetics.

Clinical Evidence

Bench testing only. Includes dynamic fatigue testing per ISO 14801 and FDA guidance, dimensional analysis, reverse engineering of implant-abutment connections, sterilization validation (ISO 17665, ISO 11137), sterile packaging validation (ISO 11607), biocompatibility (ISO 10993-1), and MR safety testing (ASTM F2052, F2213, F2182, F2119).

Technological Characteristics

Materials: Ti6Al4V (ASTM F136), gold alloy (ISO 22674), titanium nitride coating. Components: Standard, temporary, multi-unit, and CAD/CAM abutments. Connectivity: Mechanical interface with OEM implants. Sterilization: Non-sterile (moist heat by user) or sterile (gamma irradiation).

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple tooth prostheses (or multi-unit screw-retained bridges/bars) supported by dental implants in the maxilla or mandible. Specific abutments for Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm are restricted to maxillary lateral and mandibular central/lateral incisors.

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

Medentika Abutment System (K142167)

Reference Devices

Medentika CAD/CAM Abutments (K150203)
Medentika CAD/CAM TiBases (K170838)
Medentika Multi-Unit Abutment (K191123)
OsseoSpeed EV (K130999, K120414)
OsseoSpeed TX (K101732)
TS System (K121995, K161604)
ET System (K140934)
NobelActive (K142260)
Nobel Replace (K020646)
Tapered Screw-Vent (K061410)
NobelReplace CC (K073142)

Related Devices

K150203 — Medentika CAD/CAM Abutments · Medentika GmbH · Oct 23, 2015
K182091 — Osstem Abutment System · Osstem Implant Co., Ltd. · Jul 12, 2019
K170838 — Medentika CAD/CAM TiBases · Medentika GmbH · Sep 15, 2017
K240570 — IPD Dental Implant Abutments · Implant Protesis Dental 2004, S.L. · Jun 7, 2024
K222215 — IPD Dental Implant Abutments · Implant Protesis Dental 2004, S.L. · Oct 21, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Medentika GmbH % Jennifer Jackson Sr. Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801 April 15, 2024 #### Re: K223113 Trade/Device Name: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 9, 2024 Received: April 10, 2024 Dear Jennifer Jackson: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K223113 Device Name Medentika Abutment System Indications for Use (Describe) Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. Implant System Compatibility Series / Implant System / Implant diameter / Platform Diameters or Implant Connection): Standard Abutment: | Medentika series of the medical device | Manufacturer of the implant system | Compatible Implant system | Implant Diameters (mm) | Platform Diameters (mm) | |-------------------------------------------------|------------------------------------------|------------------------------|----------------------------|----------------------------| | EV-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed® EV | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 | | S-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed® TX | 3.0 | 3.0 | | R-Series | ZimVie | Tapered Screw-Vent® | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | #### Temporary Abutment: | Medentika series of the medical device | Manufacturer of the implant system | Compatible Implant system | Implant Diameters (mm) | Platform Diameters (mm) | |-------------------------------------------------|------------------------------------------|------------------------------|---------------------------------|----------------------------| | S-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed® TX | 3.0 | 3.0 | | Medentika series of the medical device | Manufacturer of the implant system | Compatible Implant system | Implant Diameters (mm) | Platform Diameters (mm) | | OT-Series | OSSTEM Implant HiOssen Implant | TS System | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | Mini, Regular | | | | ET-System | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | | MedentiLOC Abutment: Type of Use (Select one or both, as applicable) �Prescription Use (Part 21 CFR 801 Subpart D) □Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ #### 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." FORM FDA 3881 (6/20) PSC Publishing Services (301) 443-6740 EF {5}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K223113 Device Name Medentika CAD/CAM TiBases #### Indications for Use (Describe) Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center. Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. Implant System Compatibility Series / Implant System / Implant diameter / Platform Diameters or Implant Connection): | Medentika series of the medical device | Manufacturer of the implant system | Compatible implant system | Implant Diameters (mm) | Platform Diameters (mm) | |----------------------------------------------|------------------------------------------|------------------------------|---------------------------------|-------------------------------| | EV-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed® EV | 3.0 | 3.0 | | F-Series | Nobel Biocare | NobelActive® CC | 3.0, 5.5 | 3.0, WP 5.5 | | OT-Series | OSSTEM Implant HiOssen Implant® | TS-System ET-System | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | Mini, Regular | | S-Series | Dentsply Implants | ASTRA TECH OsseoSpeed® TX | 3.0 | 3.0 | Type of Use (Select one or both, as applicable) 図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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {6}------------------------------------------------ | FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF | |-----------------------------------------|----------------------------------|-------------------------------------------| | DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | | | Food and Drug Administration | Expiration Date: 06/30/2023 | | | Indications for Use | See PRA Statement below. | | | 510(k) Number (if known) | | | #### K223113 #### Device Name Medentika CAD/CAM Abutments Medcutiika CAD/CAM Abutment Indications for Use (Describe) Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment. Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. Implant System Compatibility Series / Implant System / Implant diameter / Platform Diameters or Implant Connection): | Medentika series of the medical device | Manufacturer of the implant system | Compatible implant system | Implant Diameters (mm) | Platform Diameters (mm) | |----------------------------------------------|------------------------------------------|------------------------------|---------------------------------|----------------------------| | E-Series | Nobel Biocare | Replace™ Select | 6.0 | 6.0 | | EV-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed® EV | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 | | F-Series | Nobel Biocare | NobelActive® CC | 5.5 | WP 5.5 | | OT-Series | OSSTEM Implant HiOssen Implant® | TS-System ET-System | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | Mini, Regular | Type of Use (Select one or both, as applicable) 区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." FORM FDA 3881 (6/20) PSC Publishing Services (301) 443-6740 EF {7}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 # Indications for Use See PRA Statement below. 510(k) Number (if known) #### K223113 #### Device Name Medentika Multi-unit Abutments Indications for Use (Describe) Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient. lmplant System Compatibility Series / Implant System / Implant diameter / Platform Diameters or Implant Connection): | Medentika Series of the medical device | Manufacturer of the implant system | Compatible implant system | Implant Diameters (mm) | Platform Diameters (mm) | |----------------------------------------------|------------------------------------------|-----------------------------------------|--------------------------------------------------------------|----------------------------------| | E-Series | Nobel Biocare | Replace Select™ | 3.5, 4.3, 5.0 | NP 3.5, RP 4.3, WP 5.0 | | S-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed® TX | 3.5, 4.0, 4.5, 5.0 | 3.5/4.3, 4.5/5.0 | | F-Series | Nobel Biocare | NobelActive® CC, NobelReplace® CC | 3.5, 4.3, 5.0, 5.5 | NP 3.5, RP 4.3/5.0, WP 5.5 | | OT-Series | OSSTEM Implant HiOssen Implant | TS System ET System | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | Mini, Regular | Type of Use (Select one or both, as applicable) 図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." FORM FDA 3881 (6/20) 6740 EF PSC Publishing Services (301) 443- {8}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments 510(k) Summary ## 510(k) Summary ## Submitter's Contact Information | Submitter: | Straumann USA, LLC (on behalf of Medentika GmbH) 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 On the behalf of: Medentika GmbH Hammweg, 8-10 76549 Hügelsheim, Germany | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS, RAC Sr. Director, Regulatory Affairs and Quality Phone Number: +1 978 747-2509 Fax Number: +1 978 747-0023 | | Prepared By & Alternate Contact: | Nadia Fouladi Head of Regulatory Affairs International Medentika GmbH Phone number: +4972296991210 | | Date Prepared: | April 15, 2024 | ### Name of the Device | Trade Names: | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | |------------------------|-------------------------------------------------------------------------------------------------------------------------| | Common Name: | Dental implant abutment | | Classification Name: | Endosseous dental implant abutment | | Regulation Number: | 21 CFR §872.3630 | | Device Classification: | II | {9}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments 510(k) Summary Product Code(s): NHA Classification Panel: Dental ### Predicate and Reference Device(s) Primary Predicate: - . K142167 – Medentika Abutment System Reference Devices for Abutments: - K150203 Medentika CAD/CAM Abutments . - . K170838 – Medentika CAD/CAM TiBases - K191123 Medentika Multi-Unit Abutment . Reference Devices to support added compatible implants: - . K130999 and K120414 - OsseoSpeed EV - K101732 OsseoSpeed TX ● - K121995 and K161604 TS System ● - K140934 – ET System - K142260 NobelActive . - K020646 – Nobel Replace - . K061410 - Tapered Screw-Vent - K073142 – NobelReplace CC #### Device Description The Medentika abutments include abutments, abutment screws, caps, and bases which are labelled under a specific Medentika series and are compatible with a specified dental implant system. The abutments include sinqle-unit abutments intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. The abutments also include multi-unit abutments {10}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments ## 510(k) Summary indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient. The purpose of this premarket notification is to add additional abutments. The subject abutments include abutments compatible with additional dental implant systems forming a new Medentika series (the OT series). The subject abutments also include abutments compatible with new implant diameters in existing Medentika series (E, EV, F, and S). Lastly, the subject abutments include new abutment designs compatible with existing implant diameters in existing Medentika series (R). ## Indications for Use and Summary of Similarities and Differences in Technological Characteristics, Performance Testing, and Intended Use ### Medentika Standard and Temporary Abutments The subject and existing Medentika standard and temporary abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Table 1 includes the exact indications for use statements. {11}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments 510(k) Summary | Comparison | Subject Medentika Abutments - Standard abutment, temporary abutments, and MedentiLOC abutments | | | | K142167 Medentika Abutment System | | | | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------|------------------------------------------------| | Indications for use | Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. Implant System Compatibility Series (Series / Implant System / Implant diameter / Platform Diameters or Implant connection): | | | | Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Abutments are compatible with the following implant systems: Implant System | Series | Implant Diameters (mm) | | | | Standard Abutment: Medentika series of the | Manufacturer of the implant system | Compatible Implant system | Implant Diameters (mm) | Platform Diameters (mm) | Nobel Biocare Replace Select | E- Series | 3.5, 4.3, 5.0, 6.0 | | | medical device EV-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed® EV | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 | Nobel Biocare NobelActive | F- Series | 3.5, 4.3, 5.0 | | | S-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed® TX | 3.0 | 3.0 | Biomet 3i Osseotite® Certain | H- Series | 3.25, 4.0, 5.0 | | | R-Series | ZimVie | Tapered Screw-Vent® | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | Biomet 3i Osseotite | I- Series | 3.25, 3.75, 4.0, 5.0 | | | Temporary Abutment: Medentika series of the | Manufacturer of the implant system | Compatible Implant system | Implant Diameters (mm) | Platform Diameters (mm) | Nobel Biocare Branemark Straumann Bone Level | K- Series L- Series | 3.3, 3.75, 4.0, 5.0 3.3, 4.1, 4.8 | | | medical device | | | | | Straumann Standard | N- Series | 3.3, 4.1, 4.8 | | | S-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed® TX | 3.0 | 3.0 | Zimmer Tapered Screw-vent | R- Series | 3.3, 3.7, 4.1, 4.7, 6.0 | | | MedentiLOC Abutment: Medentika series of the medical device | Manufacturer of the implant system | Compatible Implant system | Implant Diameters (mm) | Platform Diameters (mm) | Astra Tech OsseoSpeed | S- Series | 3.5, 4.0, 4.5, 5.0 | | | | | | | | Denstply Friadent Frialit/XiVE Dentsply Firadent Ankylos | T- Series Y- Series | 3.4, 3.8, 4.5, 5.5 3.5, 4.5, 5.5, 7.0 | | | OT-Series | OSSTEM Implant HiOssen Implant | TS System ET-System | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | Mini, Regular | | | | Table 1 – Comparison of the Proposed and Previously Cleared Indications for use for the Medentika Standard and Temporary Abutments. {12}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments ## 510(k) Summary The design of the subject Medentika standard and temporary abutments is consistent with that of the previously cleared Medentika standard and temporary abutments. A detailed comparison of the subject and previously cleared Medentika standard and temporary abutments is included in Table 1. | Comparison | Subject Medentika abutments | K142167 Medentika abutment system | Equivalence | |----------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Product Code | NHA | NHA | Equivalent | | Series | R, S, EV | E, F, H, I, K, L, N, R. S. T | The EV series is a new series. Addition of abutments compatible with OsseoSpeed EV implants does not raise different questions of safety and effectiveness. Mechanical testing and engineering analyses demonstrate equivalency. | | Abutment Designs | Standard abutment Temporary abutment | Standard abutment Temporary abutment | Equivalent | | Prosthesis Attachment | Cement retained | Cement retained | Equivalent | | Restoration | Single unit | Single unit | Equivalent | | Compatible Implant Body Diameter (mm) | 3.0-5.7 | 3.5-6 | Addition of abutments compatible with Ø3.0mm implants do not raise different questions of safety and effectiveness. Mechanical testing and engineering analyses demonstrate equivalency. | | Gingival Height (mm) | 1-3.5 | 1-3 | The increase in gingival height does not raise different questions of safety and effectiveness. Mechanical testing and engineering analyses demonstrate equivalency. | | Abutment Angulation (degrees) | Straight, 16°, 18° | Straight, 16°, 18°, 21° | Equivalent | | Abutment & Abutment Screw Materials | Ti6Al4V, medical grade 5, conforming to ASTM F136 | Ti6Al4V, medical grade 5, conforming to ASTM F136 | Equivalent | {13}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | Comparison | Subject Medentika abutments | K142167 Medentika abutment system | Equivalence | |---------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-------------| | Sterilization | Supplied non- sterile Moist heat sterilized by end user | Supplied non- sterile Moist heat sterilized by end user | Equivalent | | Usage | Single-patient, single-use | Single-patient, single-use | Equivalent | 510(k) Summary Table 2 – Comparative Summary of the Proposed and the Previously Cleared Medentika Standard and Temporary Abutments The Medentika MedentiLOC abutments are also part of the Medentika standard and temporary grouping of abutments. These abutments are designed for overdenture attachments. The design of the subject MedentiLOC abutments is consistent with that of the previously cleared MedentiLOC abutments. A detailed comparison of the subject and previously cleared MedentiLOC abutments is supplied in Table 3. | Comparison | Subject Medentika MedentiLOC | K142167 Medentika MedentiLOC | Equivalence | |--------------------------|----------------------------------------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Product Code | NHA | NHA | Equivalent | | Series | OT | E, F, H, I, K, L, N, R, S, T, Y | The OT series is a new series. Addition of abutments compatible with OSSTEM Implants TS System and HiOssen Implants ET System implants does not raise different questions of safety and effectiveness. Mechanical testing and engineering analyses demonstrate equivalency. | | Abutment Designs | Overdenture attachment abutments | Overdenture attachment abutments | Equivalent | | Prosthesis Attachment | Patrices-Matrices | Patrices-Matrices | Equivalent | {14}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | Comparison | Subject Medentika MedentiLOC | K142167 Medentika MedentiLOC | Equivalence | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------| | Restoration | Multi-unit (full or partial overdenture) | Multi-unit (full or partial overdenture) | Equivalent | | Implant-Abutment Platform Diameter (mm) | 3.5 - 7.0 | | Equivalent | | Gingival Height (mm) | 1-5 | | Equivalent | | Abutment Angulation (degrees) | Straight | Straight, 15° | Equivalent | | Abutment & Abutment screw materials | Ti6Al4V, medical grade 5, conforming to ASTM F136 Titanium nitride coating on abutments | Ti6Al4V, medical grade 5, conforming to ASTM F136 Titanium nitride coating on abutments | Equivalent | | Sterilization | Supplied non-sterile Moist heat sterilized by end user | Supplied non-sterile Moist heat sterilized by end user | Equivalent | | Usage | Single-patient, single-use | Single-patient, single- use | Equivalent | #### 510(k) Summary Table 3 - Comparative Summary of the Proposed and Previously Cleared MedentiLOC Abutments (part of the standard and temporary abutments grouping) #### Medentika CAD/CAM TiBases The subject and existing Medentika TiBase CAD/CAM abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla of a partially or fully edentulous patient. The two-piece abutment which compose the final abutment consists of the pre-manufactured titanium base component composed of titanium alloy and the CAD/CAM patient matched mesostructured (or superstructure) composed of zirconia. The CAD/CAM patient matched mesostructure (or superstructure) composed of zirconia is intended to be cemented to the pre-manufactured titanium base using Multilink® Hybrid Abutment Cement by Ivoclar Vivadent (K130436). Table 4 includes the exact indications for use statements. {15}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments 510(k) Summary | Comparison | Subject Medentika Titanium bases | | | K170838 Medentika Titanium bases | | | | K150203 Medentika Titanium bases | | | | | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------------|--------|-------------------------------|--------------------------------| | Indications for use | Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center. Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. Implant System Compatibility Series (Series / Implant System / Implant diameter / Platform Diameters or Implant Connection): | | | Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | | | | Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | | | | | | | | Medentika Series | Manufacturer of the implant system | Compatible implant system | Implant Diameter (mm) | Platform Diameter (mm) | Implant System Combability | Series | Implant Diameter r (mm) | Platform Diameter (mm) | Implant System Combability | Series | Implant Diameter (mm) | Platform Diameter (mm) | | | EV-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed ® EV | 3.0 | 3.0 | Nobel Biocare Replace Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 | Nobel Biocare Replace™ Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 | | | S-Series | DENTSPLY Implants | ASTRA TECH OsseoSpeed ®TX | 3.0 | 3.0 | Dentsply® Implants/AS TRA TECH OsseoSpeed ® EV | EV | 3.6, 4.2, 4.8, 5.4 | 3.6, 4.2, 4.8, 5.4 | Nobel Biocare NobelActive™ | F | 3.5, 4.3, 5.0 | 3.5, 3.9(4.3), 3.9 (5.0) | | | F-Series | Nobel Biocare | Nobel Active® CC | 3.0, 5.5 | 3.0, WP 5.5 | Nobel Biocare NobelActive | F | 3.5, 4.3, 5.0 | 3.5, 3.9(4.3), 3.9 (5.0) | Biomet 3i® Osseotite Certain® | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | | | OT-Series | OSSTEM Implant HiOssen Implant | TS System ET System | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | Mini, Regular | Biomet 3i Osseotite | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | Biomet 3i Osseotite® | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | | | | | | | | Biomet 3i Osseotite Certain | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | Nobel Biocare Branemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 | | | | | | | | Nobel Biocare Branemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 | Straumann Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | | | | | | | | Straumann Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | Straumann Soft Tissue Level | N | 3.3, 4.1, 4.8 | 3.5 (NNC), 4.8, 6.5 | | | | | | | | Straumann Soft Tissue Level | N | 3.3, 4.1, 4.8 | 3.5 (NNC), 4.8, 6.5 | Zimmer Tapered Screw-vent® | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | | | | | | | | Zimmer Tapered Screw-vent | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | Astra Tech OsseoSpeed™ | S | 3.5, 4.0, 4.5, 5.0 | 3.5, 4.0, 4.5, 5.0 | | | | | | | | | | | | Denstply Friadent® Frialit/XiVE® | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 | | | | | | | | | | | | Dentsply Firadent® Ankylos® | Y | 3.5, 4.5, 5.5, 7.0 | 3.5, 4.5, 5.5, 7.0 | {16}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | | | Astra Tech OsseoSpeed | S | 3.5, 4.0, 4.5, 5.0 | 3.5, 4.0, 4.5, 5.0 | Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. | |--|--|--------------------------------------|---|-----------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Dentsply Friadent Frialit/XiVE | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 | | | | | Dentsply Friadent Ankylos | Y | 3.5, 4.5, 5.5, 7.0 | 3.5, 4.5, 5.5, 7.0 | Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center. | 510(k) Summary Table 4 – Comparison of the proposed and previously cleared indications for use for the Medentika Ti Base CAD/CAM abutments {17}------------------------------------------------ ## Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments ## 510(k) Summary The design of the subject Medentika TiBase CAD/CAM abutments is consistent with that of the previously cleared Medentika TiBase CAD/CAM abutments. A detailed comparison of the subject and previously cleared Medentika TiBase CAD/CAM abutments is included in Table 5. | Comparison | Subject Medentika Titanium bases | K170838 Medentika Titanium bases | K150203 Medentika Titanium bases | Equivalence | |----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…