Who is the manufacturer of Multi-unit Abutments?

Medentika GmbH filed the 510(k) submission for Multi-unit Abutments (K191123).

What is the FDA product code for Multi-unit Abutments?

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

What is the regulatory pathway for Multi-unit Abutments?

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

What are the predicate devices for Multi-unit Abutments?

Straumann Screw Retained Abutments (K171757).

Who can help prepare an FDA 510(k) submission like 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.

Multi-unit Abutments

K191123 · Medentika GmbH · NHA · Jan 6, 2020 · Dental

Device Facts

Record ID	K191123
Device Name	Multi-unit Abutments
Applicant	Medentika GmbH
Product Code	NHA · Dental
Decision Date	Jan 6, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended Use

The Multi-unit Abutments are directly screwed into the implant and have a universal mounting on the face side for various additional prosthetic parts. The bridge or bar elements are produced to fit to the prosthetic parts by which they are screwed onto the Multi-unit Abutments.

Device Story

Multi-unit abutments are two-piece dental abutments consisting of a bottom abutment and a top cap/base. They are screwed onto osseointegrated dental implants to support multi-unit screw-retained bridges and bars. Available in straight and angled configurations with various gingival heights and platform diameters. Used by clinicians in dental clinics to restore function and aesthetics for partially or fully edentulous patients. The device provides a universal interface for prosthetic parts, ensuring a low-tension screw connection. Benefits include standardized support for prosthetic suprastructures at the gingival level.

Clinical Evidence

Bench testing only. Dynamic fatigue and static strength testing conducted per ISO 14801:2016. Biocompatibility evaluated per ISO 10993-1 and ISO 10993-5. Sterility validated to SAL 10^-6 per ISO 11137-1. Endotoxin analysis performed with a limit of 20 EU/device.

Technological Characteristics

Materials: Ti6Al4V (ASTM F136), Gold, Cobalt Chromium. Design: Two-piece abutment (bottom abutment + top cap/base). Configurations: Straight and angled (17°, 30°). Sterilization: Gamma irradiation (provided sterile). Connectivity: Mechanical interface to dental implants. Standards: ISO 14801 (fatigue), ISO 10993 (biocompatibility), ISO 11137 (sterilization).

Indications for Use

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. Compatible with specific Medentika series (EV, F, H, L, N, R) for various dental implant systems.

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

Straumann Screw Retained Abutments (K171757)

Reference Devices

Medentika Abutment System (K142167)
Straumann CARES Abutments CoCr (K172798)
Medentika CAD/CAM TiBases (K170838)
BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment (K162890)

Related Devices

K093643 — MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS · Nobel Biocare AB · Jun 24, 2010
K203252 — Multi-unit Abutments for CONELOG · BioHorizons Implant Systems, Inc. · Mar 16, 2021
K061477 — MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS · Nobel Biocare AB · Aug 11, 2006
K123491 — BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT · Biodenta Swiss AG · May 30, 2013
K153779 — Abutment for Bridges · Altatec GmbH · Mar 31, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 6, 2020 Medentika GmbH % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801 Re: K191123 Trade/Device Name: Multi-unit Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 4, 2019 Received: December 5, 2019 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 (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 located 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}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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. Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) #### K191123 Device Name: 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. Multi-unit Abutments are used for the restoration of the following dental implant systems: | Medentika series | Implant system | Implant diameter | Platform diameter | |---------------------|-----------------------------------------------------|---------------------|--------------------| | EV-Series | Dentsply® Implants - ASTRA TECH OsseoSpeed® | 3.6, 4.2, 4.8 | 3.6, 4.2, 4.8 | | F-Series | Nobel Biocare NobelActive - NobelReplace Conical | 3.5, 4.3, 5.0 | NP 3.5, RP 4.3/5.0 | | H-Series | Biomet 3i - Certain | 3.25, 4.0 | 3.4, 4.1 | | L-Series | Straumann - Bone Level | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | | N-Series | Straumann - Soft Tissue Level | 4.1, 4.8 | 4.8, 6.5 | | R-Series | Zimmer Dental Tapered Screw-vent | 3.3, 3.7, 4.1, 4.7 | 3.5, 4.5 | 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 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}------------------------------------------------ ### Medentika Multi-unit Abutments 510(k) Summary ## 510(k) Summary ### Submitter's Contact Information | Submitter: | Straumann USA, LLC 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 Director of Regulatory Affairs Phone Number: +1-978-747-2509 Fax Number: +1-978-747-0023 | | | | | Prepared By & Alternate Contact: | Olivier Russo Regulatory Affairs and Compliance Manager Institut Straumann AG Phone number : +41 61 965 1260 | | | | | Date of Submission: | January 6, 2020 | | | | ### Name of the Device | Trade Names: | Multi-unit Abutments | |------------------------|------------------------------------| | Common Name: | Endosseous dental implant abutment | | Classification Name: | Endosseous dental implant abutment | | Regulation Number: | 21 CFR 872.3630 | | Device Classification: | II | | Product Code(s): | NHA | | Classification Panel: | Dental | {4}------------------------------------------------ ### Medentika Multi-unit Abutments 510(k) Summary ### Predicate Device(s) Primary Predicate: - K171757 Straumann Screw Retained Abutments . Reference Devices: - K142167 Medentika Abutment System . - K172798 Straumann CARES Abutments CoCr . - . K170838 – Medentika CAD/CAM TiBases - K162890 BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and . Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment - K180564 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika . CAD/CAM TiBases #### Device Description The proposed Multi-unit Abutments are dental abutments, which are intended to be screwed onto osseointegrated dental implants to provide support for prosthetic suprastructures on the gingival level. Multi-unit abutments can be used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. Multi-unit abutments are very similar to the already FDA-cleared Straumann Screw-Retained Abutment System. Multi-unit abutments are available as straight abutments, which have an integrated thread and can be screwed directly into the implant, or as angled abutments, which can be screwed onto the implant with the corresponding abutment screw. All models of Multi-unit abutments have a universal interface for a variety of prefabricated prosthetic parts, e.g. Multi-unit caps, which become part of the superstructure and ensure a low-tension screw connection of the multi-unit prosthetics. The Multi-Unit caps or base are used in conjunction with the Multi-Unit Abutment. The Multi-Unit Abutment is considered the bottom half of a two-piece abutment and the Multi-Unit Caps or Multi-Unit Titanium base are considered the top half of the two-piece abutment. {5}------------------------------------------------ ### Medentika Multi-unit Abutments #### 510(k) Summary Multi-unit Abutments exist in two model types: straight multi-unit abutments without rotational indexing with various gingival heights and platform diameters and angled multi-unit abutments with rotary indexing with various ginqival heights and platform diameters. ### Intended Use The Multi-unit Abutments are directly screwed into the implant and have a universal mounting on the face side for various additional prosthetic parts. The bridge or bar elements are produced to fit to the prosthetic parts by which they are screwed onto the Multi-unit Abutments. #### Indications for Use 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. Multi-unit Abutments are used for the restoration of the following dental implant systems: | Medentika series | Implant system | Implant diameter | Platform diameter | |---------------------|-----------------------------------------------------|---------------------|--------------------| | EV-Series | Dentsply® Implants - ASTRA TECH OsseoSpeed® | 3.6, 4.2, 4.8 | 3.6, 4.2, 4.8 | | F-Series | Nobel Biocare NobelActive - NobelReplace Conical | 3.5, 4.3, 5.0 | NP 3.5, RP 4.3/5.0 | | H-Series | Biomet 3i - Certain | 3.25, 4.0 | 3.4, 4.1 | | L-Series | Straumann - Bone Level | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | | N-Series | Straumann - Soft Tissue Level | 4.1, 4.8 | 4.8, 6.5 | | R-Series | Zimmer Dental Tapered Screw-vent | 3.3, 3.7, 4.1, 4.7 | 3.5, 4.5 | ### Technological Characteristics The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1. The reference device K162890 is included for adoption of the sterilization validation. K180564 is referenced in the submission to support the MRI compatibility of the subject devices. {6}------------------------------------------------ ## Medentika Multi-unit Abutments | Feature | Subject Device | Predicate Device | Reference Devices | | | Equivalence discussion | |----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Medentika Multi-unit Abutments | K171757 - Straumann Screw Retained Abutments | K142167- Medentika Abutment System | K172798 - Straumann CARES Abutments CoCr | K170838 - Medentika CAD/CAM TiBases | | | Indications for use | 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. Multi-unit Abutments are used for the restoration of the following dental implant systems (Implant System / Series / Implant diameter / Platform diameter): Dentsply® Implants - ASTRA TECH OsseoSpeed® / EV- Series / Diameter 3.6, 4.2, 4.8 / Platform 3.6, 4.2, 4.8 Nobel Biocare NobelActive - NobelReplace Conical / F-Series / Diameter 3.5, 4.3, 5.0 / Platform NP 3.5, RP 4.3/5.0 Biomet 3i - Certain / H- Series / Diameter 3.25, 4.0 / Platform 3.4, 4.1 Straumann - Bone Level / L-Series / Diameter 3.3, 4.1, 4.8 / Platform 3.3, 4.1, 4.8 Straumann - Soft Tissue Level / N-Series / | The Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw- retained restorations. | 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) Nobel Biocare Replace Select/E-Series/3.5, 4.3, 5.0, 6.0 Nobel Biocare Nobel Active/F-Series/3.5, 4.3, 5.0 Biomet 3i Osseotite Certain/H-Series/3.25, 4.0, 5.0 Biomet 3i Osseotite/ I- Series/3.25, 3.75, 4.0, 5.0 Nobel Biocare Branemark/K- Series/3.3, 3.75, 4.0, 5.0 Straumann Bone Level/L-Series/3.3, 4.1, 4.8 | The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw- retained. | Medentika 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. Implant System Compatibility/Series/Im plant Diameter (mm)/Platform Diameter (mm) Nobel Biocare Replace Select/E-Series/3.5, 4.3, 5.0, 6.0/3.5, 4.3, 5.0, 6.0 Dentsply Implants/ASTRA TECH OsseoSpeed EV/EV- Series/3.6, 4.2, 4.8, 5.4/3.6, 4.2, 4.8, 5.4 Nobel Biocare Nobel Active/F-Series/3.5, 4.3, 5.0/3.5, 3.9 (4.3), 3.9 (5.0) Biomet 3i Osseotite Certain/H-Series/3.25, 4.0, 5.0/3.4, 4.1, 5.0 Biomet 3i Osseotite/ I- Series/3.25, 3.75, 4.0, 5.0/3.4, 4.1, 5.0 Nobel Biocare Branemark/K- | Equivalent The subject device has similar indications for use as the predicate and reference devices which is to give a support for multi-unit prosthetic reconstructions such as bridges and bars. The compatible implant systems are a combination of the previously cleared compatibilities under K142167 and K170838. | | Feature | Subject Device | Predicate Device | Reference Devices | | | Equivalence discussion | | | Medentika Multi-unit Abutments | K171757 - Straumann Screw Retained Abutments | K142167- Medentika Abutment System | K172798 - Straumann CARES Abutments CoCr | K170838 - Medentika CAD/CAM TiBases | | | | Diameter 4.1, 4.8 / Platform 4.8, 6.5 Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1, 4.1, 4.7 / Platform 3.5, 4.5 | | Straumann Standard/N-Series/3.3, 4.1, 4.8 Zimmer Tapered Screw-Vent/R- Series/3.3, 3.7, 4.1, 4.7, 6.0 Astra Tech OsseoSpeed/S- Series/3.5, 4.0, 4.5, 5.0 Dentsply Friadent Frialit/Xive/T- Series/3.4, 3.8, 4.5, 5.5 Dentsply Friadent Ankylos/Y-Series/3.5, 4.5, 5.5, 7.0 | | Series/3.3, 3.75, 4.0, 5.0/3.5, 4.1, 4.1, 5.1 Straumann Bone Level/L-Series/3.3, 4.1, 4.8/3.3, 4.1, 4.8 Straumann Soft Tissue Level/N-Series/3.3, 4.1, 4.8/3.5 (NNC), 4.8, 6.5 Zimmer Tapered Screw-Vent/R- Series/3.3, 3.7, 4.1, 4.7, 6.0/3.5, 4.5, 5.7 Astra Tech OsseoSpeed/S- Series/3.5, 4.0, 4.5, 5.0/3.5, 4.0, 4.5, 5.0 Dentsply Friadent Frialit/Xive/T- Series/3.4, 3.8, 4.5, 5.5/3.4, 3.8, 4.5, 5.5 Dentsply Friadent Ankylos/Y-Series/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 manufactures at a validated milling center. | | | Abutment Design | Straight and angled | Straight and angled | Straight and angled | Straight and angled | Straight | Identical | | Feature | Subject Device | Predicate Device | Reference Devices | | | | | | Medentika Multi-unit Abutments | K171757 - Straumann Screw Retained Abutments | K142167- Medentika Abutment System | K172798 - Straumann CARES Abutments CoCr | K170838 - Medentika CAD/CAM TiBases | Equivalence discussion | | Interface | Engaging / Non engaging | Engaging | Engaging / Non engaging | Engaging | Engaging | Identical to reference device K142167 | | Abutment angulation to Engagement feature | Straight, 17°, 30° | 0°, 17°, 30° | Straight, 15°, 16°, 18°, 21° | Straight | Straight | Equivalent The subject device has the identical range of angulation as the primary predicate devices. | | Compatible Abutment/Implant Interface Series / Implant systems Diameter(s) | Dentsply® Implants - ASTRA TECH OsseoSpeed® / EV- Series / Diameter 3.6, 4.2, 4.8 Nobel Biocare NobelActive - NobelReplace Conical / F-Series / Diameter 3.5, 4.3, 5.0 Biomet 3i - Certain / H- Series / Diameter 3.25, 4.0 Straumann - Bone Level / L-Series / Diameter 3.3, 4.1, 4.8 Straumann - Soft Tissue Level / N-Series / Diameter 4.1, 4.8 Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1, 4.7 | Straumann Bone Level NC (Narrow CrossFit) / Diameter 3.3 Straumann Bone Level RC (Regular CrossFit) / Diameter 4.1, 4.8 | Nobel Biocare Replace Select / E-Series / Diameter 3.5, 4.3, 5.0, 6.0 Nobel Biocare NobelActive / NobelReplace conical / F-Series / Diameter 3.5, 4.3, 5.0 Biomet 3i - Certain / H- Series / Diameter 3.25, 4.0, 5.0 Biomet 3i Osseotite/ I- Series / Diameter 3.25, 3.75, 4.0, 5.0 Nobel Biocare Branemark - K Series / Diameter 3.3, 3.75, 4.0, 5.0 Straumann - Bone Level / L-Series / Diameter 3.3, 4.1, 4.8 Straumann - Soft Tissue Level / N-Series / Diameter 3.3, 4.1, 4.8 | Straumann Bone Level NC (Narrow CrossFit), and RC (Regular CrossFit) Straumann Soft Tissue Level RN (Regular Neck), WN (Wide Neck) | Abutments are compatible with the following implant systems: Nobel Biocare Replace™ Select E- Series 3.5, 4.3, 5.0, 6.0 Dentsply® Implants/AST RA TECH OsseoSpeed® EV EV- Series 3.6, 4.2, 4.8, 5.4 Nobel Biocare NobelActive™/NobelR eplace conical F-Series 3.5, 4.3, 5.0 Biomet 3i Osseotite® Certain® H-Series 3.25, 4.0, 5.0 Biomet 3i Osseotite® I- Series 3.25, 3.75, 4.0, 5.0 Nobel Biocare Brånemark K-Series 3.3, 3.75, 4.0, 5.0 Straumann Bone Level L-Series | Equivalent The compatible implant systems are a combination of the previously cleared compatibilities under K142167 and K170838. Dentsply® Implants - ASTRA TECH OsseoSpeed® / EV- Series is part of the reference device K170838, complementary performance testing was performed and demonstrated equivalence. | | Feature | Subject Device | Predicate Device | Reference Devices | | | Equivalence discussion | | | Medentika Multi-unit Abutments | K171757 - Straumann Screw Retained Abutments | K142167- Medentika Abutment System | K172798 - Straumann CARES Abutments CoCr | K170838 - Medentika CAD/CAM TiBases | | | Material of Abutment (bottom half of two-piece abutment) | Ti6Al4V, medical grade 5, conforming ASTM F 136 | Titanium-6aluminum- 7niobium alloy (TAN) conforming to ISO 5832-11 | Ti6Al4V, medical grade 5, conforming ASTM F 136 | Cobalt-chromium alloy | Ti6Al4V, medical grade 5, conforming ASTM F 136 | Equivalent The subject device uses the type of material as the reference devices K142167 and K170838 | | Gingival Heights | GH 0.6 to GH 5.5 mm | GH 1.0 to GH 5.5 mm | GH 0.5 to GH 5.5 mm | Not applicable Gingiva Height is defined/designed by the dentist using CARES Visual | Not applicable, Gingiva Height is defined/designed by the dentist | Equivalent The subject device has a similar range of Gingival Height as the predicate and reference devices | | Feature | Subject Device | Predicate Device | Reference Devices | | | Equivalence discussion | | | Medentika Multi-unit Abutments | K171757 - Straumann Screw Retained Abutments | K142167- Medentika Abutment System | K172798 - Straumann CARES Abutments CoCr | K170838 - Medentika CAD/CAM TiBases | | | Restoration…

Multi-unit Abutments

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

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Multi-unit Abutments

Device Facts

Intended Use

Device Story

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Special Controls

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