(252 days)
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 EV-Series, Implant system Dentsply® Implants - ASTRA TECH OsseoSpeed®, Implant diameter 3.6, 4.2, 4.8, Platform diameter 3.6, 4.2, 4.8
Medentika series F-Series, Implant system Nobel Biocare NobelActive - NobelReplace Conical, Implant diameter 3.5, 4.3, 5.0, Platform diameter NP 3.5, RP 4.3/5.0
Medentika series H-Series, Implant system Biomet 3i - Certain, Implant diameter 3.25, 4.0, Platform diameter 3.4, 4.1
Medentika series L-Series, Implant system Straumann - Bone Level, Implant diameter 3.3, 4.1, 4.8, Platform diameter 3.3, 4.1, 4.8
Medentika series N-Series, Implant system Straumann - Soft Tissue Level, Implant diameter 4.1, 4.8, Platform diameter 4.8, 6.5
Medentika series R-Series, Implant system Zimmer Dental Tapered Screw-vent, Implant diameter 3.3, 3.7, 4.1, 4.7, Platform diameter 3.5, 4.5
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.
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.
The provided document is a 510(k) premarket notification for "Multi-unit Abutments." This document establishes substantial equivalence to predicate devices based on technological characteristics and performance testing. However, it does not describe a study that proves the device meets specific acceptance criteria related to AI/algorithm performance in a diagnostic or interpretive context.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" outlined in the request (e.g., MRMC study, ground truth, expert consensus, sample size, effect size) are typically attributes of studies supporting AI/ML-driven medical devices that output a diagnostic or interpretive result. The device described in this 510(k) is a physical dental implant component, not a software or AI device.
Therefore, I cannot extract the requested information regarding AI/algorithm performance. The provided text outlines:
- Device Description: Multi-unit abutments are dental components screwed onto implants to support prosthetic suprastructures (e.g., bridges, bars).
- Performance Testing: This refers to mechanical and biological testing (e.g., dynamic fatigue, static strength, biocompatibility, sterilization) to ensure the physical device's safety and effectiveness, not the performance of an AI algorithm.
- Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the new device is as safe and effective as previously cleared predicate devices through comparisons of indications for use, design, materials, and mechanical properties.
Specifically, here's why the requested information cannot be provided from the text:
- Acceptance Criteria/Reported Device Performance (Table): The document provides a table of "Technological Characteristics" comparing the subject device to predicates, but these are design and material specifications, not performance metrics for an AI algorithm (e.g., sensitivity, specificity, AUC).
- Sample Size and Data Provenance: Not applicable for an AI test set. The document discusses "test sets" in the context of mechanical fatigue and static strength tests (e.g., testing multiple abutment units), but not a dataset of images or patient cases for AI evaluation.
- Number of Experts/Ground Truth Establishment/Qualifications: Not applicable. There's no AI component requiring expert review for ground truth.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable. This device is a physical component, not an AI assisting human readers.
- Standalone Performance: Not applicable. There is no AI algorithm to evaluate in standalone mode.
- Type of Ground Truth Used: Not applicable. Ground truth for an AI would involve labeled data (e.g., disease presence/absence from pathology), which is irrelevant for a dental abutment.
- Sample Size for Training Set: Not applicable.
- Ground Truth for Training Set: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (dental abutments), which successfully demonstrates substantial equivalence based on engineering and biocompatibility standards. It does not involve any artificial intelligence or machine learning component, and thus the acceptance criteria and study details relevant to AI performance are absent.
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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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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
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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:
| Medentikaseries | Implant system | Implantdiameter | Platform diameter |
|---|---|---|---|
| EV-Series | Dentsply® Implants - ASTRA TECHOsseoSpeed® | 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)
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Medentika Multi-unit Abutments
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052 | |||
|---|---|---|---|---|
| On the behalf of: | ||||
| Medentika GmbH | ||||
| Hammweg 8-1076549 Hügelsheim, Germany | ||||
| Contact Person: | Jennifer M. Jackson, MSDirector of Regulatory AffairsPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023 | |||
| Prepared By &Alternate Contact: | Olivier RussoRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone 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 |
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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.
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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:
| Medentikaseries | Implant system | Implantdiameter | Platform diameter |
|---|---|---|---|
| EV-Series | Dentsply® Implants - ASTRA TECHOsseoSpeed® | 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.
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Medentika Multi-unit Abutments
| Feature | Subject Device | Predicate Device | Reference Devices | Equivalencediscussion | ||
|---|---|---|---|---|---|---|
| Medentika Multi-unitAbutments | K171757 -Straumann ScrewRetained Abutments | K142167- MedentikaAbutment System | K172798 -Straumann CARESAbutments CoCr | K170838 -MedentikaCAD/CAM TiBases | ||
| Indications for use | Multi-unit abutments areindicated for use withdental implants as asupport for multi-unitscrew retained bridgesand bars in the maxillaor mandible of a partiallyor fully edentulouspatient.Multi-unit Abutments areused for the restorationof the following dentalimplant systems(Implant System / Series/ Implant diameter /Platform diameter):Dentsply® Implants -ASTRA TECHOsseoSpeed® / EV-Series / Diameter 3.6,4.2, 4.8 / Platform 3.6,4.2, 4.8Nobel BiocareNobelActive -NobelReplace Conical /F-Series / Diameter 3.5,4.3, 5.0 / Platform NP3.5, RP 4.3/5.0Biomet 3i - Certain / H-Series / Diameter 3.25,4.0 / Platform 3.4, 4.1Straumann - Bone Level/ L-Series / Diameter3.3, 4.1, 4.8 / Platform3.3, 4.1, 4.8Straumann - Soft TissueLevel / N-Series / | The Straumann® ScrewRetained Abutmentsare indicated to beplaced into the implantsof the Straumann®Dental Implant Systemto provide support forprostheticreconstructions such ascrowns, bridges andbars.The final processeddevices have thepurpose of restoringchewing function.Straumann® ScrewRetained Abutmentsare indicated for screw-retained restorations. | Medentika abutmentsare intended for usewith dental implants asa support for single ormultiple toothprostheses in themaxilla or mandible ofa partially or fullyedentulous patient.Abutments arecompatible with thefollowing implantsystems:ImplantSystem/Series/ImplantDiameters (mm)Nobel Biocare ReplaceSelect/E-Series/3.5,4.3, 5.0, 6.0Nobel Biocare NobelActive/F-Series/3.5,4.3, 5.0Biomet 3i OsseotiteCertain/H-Series/3.25,4.0, 5.0Biomet 3i Osseotite/ I-Series/3.25, 3.75, 4.0,5.0Nobel BiocareBranemark/K-Series/3.3, 3.75, 4.0,5.0Straumann BoneLevel/L-Series/3.3, 4.1,4.8 | The Straumann®CARES® AbutmentsCoCr are indicated forsingle toothreplacement andmultiple toothrestorations. Theprosthetic restorationcan be cemented ordirectlyveneered/screw-retained. | Medentika CAD/CAMAbutments areintended for use withdental implants as asupport for single ormultiple toothprostheses in themaxilla or mandible ofa partially or fullyedentulous patient.Implant SystemCompatibility/Series/Implant Diameter(mm)/PlatformDiameter (mm)Nobel Biocare ReplaceSelect/E-Series/3.5,4.3, 5.0, 6.0/3.5, 4.3,5.0, 6.0DentsplyImplants/ASTRA TECHOsseoSpeed EV/EV-Series/3.6, 4.2, 4.8,5.4/3.6, 4.2, 4.8, 5.4Nobel Biocare NobelActive/F-Series/3.5,4.3, 5.0/3.5, 3.9 (4.3),3.9 (5.0)Biomet 3i OsseotiteCertain/H-Series/3.25,4.0, 5.0/3.4, 4.1, 5.0Biomet 3i Osseotite/ I-Series/3.25, 3.75, 4.0,5.0/3.4, 4.1, 5.0Nobel BiocareBranemark/K- | EquivalentThe subject device hassimilar indications foruse as the predicateand reference deviceswhich is to give asupport for multi-unitprostheticreconstructions such asbridges and bars.The compatible implantsystems are acombination of thepreviously clearedcompatibilities underK142167 and K170838. |
| Feature | Subject Device | Predicate Device | Reference Devices | Equivalence discussion | ||
| Medentika Multi-unitAbutments | K171757 -Straumann ScrewRetained Abutments | K142167- MedentikaAbutment System | K172798 -Straumann CARESAbutments CoCr | K170838 -MedentikaCAD/CAM TiBases | ||
| Diameter 4.1, 4.8 /Platform 4.8, 6.5Zimmer Dental TaperedScrew-vent / R-Series /Diameter 3.3, 3.7, 4.1,4.1, 4.7 / Platform 3.5,4.5 | StraumannStandard/N-Series/3.3,4.1, 4.8Zimmer TaperedScrew-Vent/R-Series/3.3, 3.7, 4.1,4.7, 6.0Astra TechOsseoSpeed/S-Series/3.5, 4.0, 4.5, 5.0Dentsply FriadentFrialit/Xive/T-Series/3.4, 3.8, 4.5, 5.5Dentsply FriadentAnkylos/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, 5.1Straumann BoneLevel/L-Series/3.3, 4.1,4.8/3.3, 4.1, 4.8Straumann Soft TissueLevel/N-Series/3.3, 4.1,4.8/3.5 (NNC), 4.8, 6.5Zimmer TaperedScrew-Vent/R-Series/3.3, 3.7, 4.1,4.7, 6.0/3.5, 4.5, 5.7Astra TechOsseoSpeed/S-Series/3.5, 4.0, 4.5,5.0/3.5, 4.0, 4.5, 5.0Dentsply FriadentFrialit/Xive/T-Series/3.4, 3.8, 4.5,5.5/3.4, 3.8, 4.5, 5.5Dentsply FriadentAnkylos/Y-Series/3.5,4.5, 5.5, 7.0/3.5, 4.5,5.5, 7.0Medentika TiBase isintended for use withthe Straumann CARESSystem.All digitally designedcopings and/or crownsare intended to be sentto Straumann formanufactures at avalidated 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-unitAbutments | K171757 -Straumann ScrewRetained Abutments | K142167- MedentikaAbutment System | K172798 -Straumann CARESAbutments CoCr | K170838 -MedentikaCAD/CAM TiBases | Equivalencediscussion | |
| Interface | Engaging /Non engaging | Engaging | Engaging /Non engaging | Engaging | Engaging | Identical to referencedevice K142167 |
| Abutmentangulation toEngagementfeature | Straight, 17°, 30° | 0°, 17°, 30° | Straight, 15°,16°, 18°, 21° | Straight | Straight | EquivalentThe subject device hasthe identical range ofangulation as theprimary predicatedevices. |
| CompatibleAbutment/ImplantInterface Series /Implant systemsDiameter(s) | Dentsply® Implants -ASTRA TECHOsseoSpeed® / EV-Series / Diameter 3.6,4.2, 4.8Nobel BiocareNobelActive -NobelReplace Conical /F-Series / Diameter 3.5,4.3, 5.0Biomet 3i - Certain / H-Series / Diameter 3.25,4.0Straumann - Bone Level/ L-Series / Diameter3.3, 4.1, 4.8Straumann - Soft TissueLevel / N-Series /Diameter 4.1, 4.8Zimmer Dental TaperedScrew-vent / R-Series /Diameter 3.3, 3.7, 4.1,4.7 | Straumann Bone LevelNC (Narrow CrossFit) /Diameter 3.3Straumann Bone LevelRC (Regular CrossFit)/ Diameter 4.1, 4.8 | Nobel Biocare ReplaceSelect / E-Series /Diameter 3.5, 4.3, 5.0,6.0Nobel BiocareNobelActive /NobelReplace conical /F-Series / Diameter3.5, 4.3, 5.0Biomet 3i - Certain / H-Series / Diameter 3.25,4.0, 5.0Biomet 3i Osseotite/ I-Series / Diameter 3.25,3.75, 4.0, 5.0Nobel BiocareBranemark - K Series /Diameter 3.3, 3.75, 4.0,5.0Straumann - BoneLevel / L-Series /Diameter 3.3, 4.1, 4.8Straumann - SoftTissue Level / N-Series/ Diameter 3.3, 4.1, 4.8 | Straumann Bone LevelNC (Narrow CrossFit),and RC (RegularCrossFit)Straumann Soft TissueLevel RN (RegularNeck), WN (WideNeck) | Abutments arecompatible with thefollowing implantsystems:Nobel BiocareReplace™ Select E-Series 3.5, 4.3, 5.0, 6.0Dentsply® Implants/ASTRA TECHOsseoSpeed® EV EV-Series3.6, 4.2, 4.8, 5.4Nobel BiocareNobelActive™/NobelReplace conical F-Series3.5, 4.3, 5.0Biomet 3i Osseotite®Certain® H-Series3.25, 4.0, 5.0Biomet 3i Osseotite® I-Series3.25, 3.75, 4.0, 5.0Nobel BiocareBrånemark K-Series3.3, 3.75, 4.0, 5.0Straumann Bone LevelL-Series | EquivalentThe compatible implantsystems are acombination of thepreviously clearedcompatibilities underK142167 and K170838.Dentsply® Implants -ASTRA TECHOsseoSpeed® / EV-Series is part of thereference deviceK170838,complementaryperformance testingwas performed anddemonstratedequivalence. |
| Feature | Subject Device | Predicate Device | Reference Devices | Equivalencediscussion | ||
| Medentika Multi-unitAbutments | K171757 -Straumann ScrewRetained Abutments | K142167- MedentikaAbutment System | K172798 -Straumann CARESAbutments CoCr | K170838 -MedentikaCAD/CAM TiBases | ||
| Material ofAbutment (bottomhalf of two-pieceabutment) | Ti6Al4V, medical grade5, conforming ASTM F136 | Titanium-6aluminum-7niobium alloy (TAN)conforming to ISO5832-11 | Ti6Al4V, medical grade5, conforming ASTM F136 | Cobalt-chromium alloy | Ti6Al4V, medical grade5, conforming ASTM F136 | EquivalentThe subject device usesthe type of material asthe reference devicesK142167 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 GingivaHeight isdefined/designed bythe dentist usingCARES Visual | Not applicable, GingivaHeight isdefined/designed bythe dentist | EquivalentThe subject device hasa similar range ofGingival Height as thepredicate and referencedevices |
| Feature | Subject Device | Predicate Device | Reference Devices | Equivalencediscussion | ||
| Medentika Multi-unitAbutments | K171757 -Straumann ScrewRetained Abutments | K142167- MedentikaAbutment System | K172798 -Straumann CARESAbutments CoCr | K170838 -MedentikaCAD/CAM TiBases | ||
| Restoration | Multi-Unit restorations | Single and Multi-Unitrestorations | Single and Multi-Unitrestorations | Single and Multi-Unitrestorations | Single restorations | IdenticalThe subject device |
| Material of screws | Ti6Al4V, medical grade5, conforming ASTM F136 | Titanium-6aluminum-7niobium alloy (TAN)conforming to ISO5832-11 | Ti6Al4V, medical grade5, conforming ASTM F136 | Titanium-6aluminum-7niobium alloy (TAN)conforming to ISO5832-11 | Ti6Al4V, medical grade5, conforming ASTM F136 | EquivalentThe subject device usesthe type of material asthe reference devicesK142167 and K170838 |
| Material of Multi-unit Base or Cap(top half of two-piece abutment) | TitaniumGoldCobalt Chromium | TitaniumGold | Not applicable | Not applicable | Not applicable | EquivalentThe subject device usesthe type of material asthe reference devicesK171757 and K172798 |
| Sterility | Delivered sterile | Delivered sterile | Delivered non sterile | Delivered non sterile | Delivered non sterile | IdenticalThe subject device isprovided sterile which isidentical to the primarypredicate K171757 |
| Sterilization by enduser | No | No | Yes | Yes | Yes | IdenticalIdentical to primarypredicate K171757 |
| Packaging | Medical gradepolyethylene blister witha sealing lid | Medical gradepolyethylene blisterwith a sealing lid | Medical gradepolyethylene blisterwith a sealing lid | Poly Bag for theabutment and Medicalgrade polyethyleneblister with a sealing lidfor the screw | Plastic box | EquivalentThe subject device usesa similar type ofpackaging as thepredicate device |
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Medentika Multi-unit Abutments
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Medentika Multi-unit Abutments
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Medentika Multi-unit Abutments
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Medentika Multi-unit Abutments
510(k) Summary
Table 1 – Technological Characteristics
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Medentika Multi-unit Abutments
510(k) Summary
Performance Testing
Dynamic fatique and static strength tests were conducted according to ISO 14801:2016 and the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated that the Multi-unit Abutments are equivalent to the predicate and reference devices. The tests were conducted in ambient air.
According to the FDA guidance entitled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"", dated June 16, 2016, the subject abutments will be in contact with tissue/bone/dentin and are external communicating devices intended for more than 30 days of patient contact. Most of the subject device materials are equivalent to the predicate and reference device materials (K171757 and K142167). There is a difference in the manufacturing process for the CoCr cap compared to the reference predicate (K172798) which was addressed through cytotoxicity testing according to ISO 10993-5.
The subject device Multi-unit Abutments are provided sterile via gamma irradiation. A sterility assurance level (SAL) of 10 6 had been validated in accordance with ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05.
The subject devices will not be marketed as non-pyrogenic. The method used to make the determination that the device meets pyrogen limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device.
The sterilization process for the multi-unit prosthetic components and bridge screws, as recommended in the labeling, was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
Conclusion
The documentation submitted in this premarket notification demonstrates the Multi-unit Abutments are substantially equivalent to the primary predicate and reference devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)