(560 days)
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 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.
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.
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.
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 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).
This looks like a 510(k) Summary for a medical device (dental abutments), which means the document is about proving "substantial equivalence" to a predicate device, not about proving clinical effectiveness or performance against pre-defined acceptance criteria in the way one might for a novel AI/software medical device.
Therefore, the information requested in your bullet points (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is not applicable to this type of regulatory submission because the device is a mechanical one, not an AI/software device. The data presented here is focused on demonstrating physical and mechanical compatibility and equivalence to previously cleared devices.
Here's why each point is not applicable and what information is provided:
-
A table of acceptance criteria and the reported device performance: This document doesn't provide a typical "acceptance criteria" table as would be seen for an AI/software device measuring diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating that the new abutments perform similarly to existing, cleared abutments through "dynamic fatigue testing" and "dimensional analysis and reverse engineering." The performance is implicitly "accepted" if these tests show equivalence to the predicate.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No "test set" in the context of diagnostic performance is mentioned. The "testing" refers to non-clinical, physical testing (fatigue, dimensional analysis). There is no patient data involved in this type of submission for a mechanical device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth, in the AI/software sense, is not established for this device. The "truth" is based on engineered specifications and physical testing.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of diagnostic output is relevant here.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" is engineering specifications and physical measurements.
-
The sample size for the training set: Not applicable. There is no AI/machine learning component to "train."
-
How the ground truth for the training set was established: Not applicable for the same reason as above.
What the document does provide regarding device performance and testing:
-
Type of Testing:
- Dynamic fatigue testing according to FDA guidance and ISO 14801 (Dentistry - implants dynamic loading test for endosseous dental implants).
- Dimensional analysis and reverse engineering of the implant-to-abutment connection platform.
- Sterilization validation (steam and gamma irradiation) referenced from K191123, ISO 17665-1, ISO/TS 17665-2, ISO 11137-1, ISO 11137-2.
- Sterile packaging validation referenced from K191123, ISO 11607-1, ISO 11607-2.
- Biocompatibility evaluations referenced from K142167, K170838, K191123, K150203, K061804 in accordance with ISO 10993-1.
- MR testing referenced from K180564 in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-13.
-
Conclusion: The tests demonstrated "implant to abutment compatibility" and "established substantial equivalency of the proposed device with predicate devices." This is the "proof" that the device meets the (implicit) acceptance of being substantially equivalent to existing, legally marketed devices.
In summary, this document is for a traditional mechanical medical device, and the regulatory pathway does not involve performance studies in the way you've outlined for AI/software-based devices.
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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)
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:
| Medentikaseries of themedicaldevice | Manufacturer ofthe implantsystem | Compatible Implantsystem | Implant Diameters(mm) | PlatformDiameters (mm) |
|---|---|---|---|---|
| EV-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed® EV | 3.0, 3.6, 4.2, 4.8,5.4 | 3.0, 3.6, 4.2, 4.8,5.4 |
| S-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed® 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:
| Medentikaseries of themedicaldevice | Manufacturer ofthe implantsystem | Compatible Implantsystem | Implant Diameters(mm) | PlatformDiameters (mm) |
|---|---|---|---|---|
| S-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed® TX | 3.0 | 3.0 |
| Medentikaseries of themedicaldevice | Manufacturer ofthe implantsystem | Compatible Implantsystem | Implant Diameters(mm) | PlatformDiameters (mm) |
| OT-Series | OSSTEM ImplantHiOssen 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)
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 seriesof the medicaldevice | Manufacturer ofthe implantsystem | Compatible implantsystem | Implant Diameters(mm) | PlatformDiameters(mm) |
|---|---|---|---|---|
| EV-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed® EV | 3.0 | 3.0 |
| F-Series | Nobel Biocare | NobelActive® CC | 3.0, 5.5 | 3.0, WP 5.5 |
| OT-Series | OSSTEM ImplantHiOssen Implant® | TS-SystemET-System | 3.5, 4.0, 4.5, 5.0,6.0, 7.0 | Mini, Regular |
| S-Series | Dentsply Implants | ASTRA TECHOsseoSpeed® 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):
| Medentikaseries of themedical device | Manufacturer ofthe implantsystem | Compatible implantsystem | Implant Diameters(mm) | PlatformDiameters (mm) |
|---|---|---|---|---|
| E-Series | Nobel Biocare | Replace™ Select | 6.0 | 6.0 |
| EV-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed® 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 ImplantHiOssen Implant® | TS-SystemET-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
"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 Seriesof the medicaldevice | Manufacturerof the implantsystem | Compatibleimplant system | Implant Diameters (mm) | PlatformDiameters(mm) |
|---|---|---|---|---|
| E-Series | Nobel Biocare | Replace Select™ | 3.5, 4.3, 5.0 | NP 3.5, RP4.3, WP 5.0 |
| S-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed® 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, RP4.3/5.0, WP5.5 |
| OT-Series | OSSTEMImplantHiOssen Implant | TS SystemET System | 3.5, 4.0, 4.5, 5.0, 6.0, 7.03.5, 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
"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 RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Medentika GmbHHammweg, 8-1076549 Hügelsheim, Germany |
|---|---|
| Contact Person: | Jennifer M. Jackson, MS, RACSr. Director, Regulatory Affairs and QualityPhone Number: +1 978 747-2509Fax Number: +1 978 747-0023 |
| Prepared By &Alternate Contact: | Nadia FouladiHead of Regulatory Affairs InternationalMedentika GmbHPhone number: +4972296991210 |
| Date Prepared: | April 15, 2024 |
Name of the Device
| Trade Names: | Medentika Abutment System, Medentika CAD/CAMAbutments, Medentika CAD/CAM TiBases, MedentikaMulti-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 | SubjectMedentika Abutments - Standard abutment, temporary abutments, and MedentiLOC abutments | K142167Medentika 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 | ImplantDiameters(mm) | ||||
| Standard Abutment:Medentikaseries of the | Manufacturerof the implantsystem | Compatible Implantsystem | ImplantDiameters(mm) | PlatformDiameters(mm) | Nobel Biocare ReplaceSelect | E-Series | 3.5, 4.3, 5.0,6.0 | |
| medical deviceEV-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed® EV | 3.0, 3.6, 4.2,4.8, 5.4 | 3.0, 3.6,4.2, 4.8, 5.4 | Nobel BiocareNobelActive | F-Series | 3.5, 4.3, 5.0 | |
| S-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed® 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:Medentikaseries of the | Manufacturerof the implantsystem | Compatible Implantsystem | ImplantDiameters(mm) | PlatformDiameters(mm) | Nobel BiocareBranemarkStraumann Bone Level | K-SeriesL-Series | 3.3, 3.75, 4.0,5.03.3, 4.1, 4.8 | |
| medical device | Straumann Standard | N-Series | 3.3, 4.1, 4.8 | |||||
| S-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed® TX | 3.0 | 3.0 | Zimmer TaperedScrew-vent | R-Series | 3.3, 3.7, 4.1,4.7, 6.0 | |
| MedentiLOC Abutment:Medentikaseries of themedical device | Manufacturerof the implantsystem | Compatible Implantsystem | ImplantDiameters(mm) | PlatformDiameters(mm) | Astra TechOsseoSpeed | S-Series | 3.5, 4.0, 4.5,5.0 | |
| Denstply FriadentFrialit/XiVEDentsply FiradentAnkylos | T-SeriesY-Series | 3.4, 3.8, 4.5,5.53.5, 4.5, 5.5,7.0 | ||||||
| OT-Series | OSSTEMImplantHiOssenImplant | TS SystemET-System | 3.5, 4.0, 4.5,5.0, 6.0, 7.03.5, 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 | SubjectMedentikaabutments | K142167Medentikaabutment system | Equivalence |
|---|---|---|---|
| FDA ProductCode | 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 ofabutments compatible with OsseoSpeedEV implants does not raise differentquestions of safety and effectiveness.Mechanical testing and engineeringanalyses demonstrate equivalency. |
| AbutmentDesigns | StandardabutmentTemporaryabutment | Standard abutmentTemporaryabutment | Equivalent |
| ProsthesisAttachment | Cement retained | Cement retained | Equivalent |
| Restoration | Single unit | Single unit | Equivalent |
| CompatibleImplant BodyDiameter (mm) | 3.0-5.7 | 3.5-6 | Addition of abutments compatible withØ3.0mm implants do not raise differentquestions of safety and effectiveness.Mechanical testing and engineeringanalyses demonstrate equivalency. |
| GingivalHeight (mm) | 1-3.5 | 1-3 | The increase in gingival height does notraise different questions of safety andeffectiveness. Mechanical testing andengineering analyses demonstrateequivalency. |
| AbutmentAngulation(degrees) | Straight, 16°,18° | Straight, 16°, 18°,21° | Equivalent |
| Abutment &AbutmentScrewMaterials | Ti6Al4V, medicalgrade 5,conforming toASTM F136 | Ti6Al4V, medicalgrade 5,conforming toASTM F136 | Equivalent |
{13}------------------------------------------------
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
| Comparison | SubjectMedentikaabutments | K142167Medentikaabutment system | Equivalence |
|---|---|---|---|
| Sterilization | Supplied non-sterileMoist heatsterilized by enduser | Supplied non-sterileMoist heatsterilized by enduser | 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 | SubjectMedentikaMedentiLOC | K142167MedentikaMedentiLOC | 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 newseries. Addition ofabutments compatible withOSSTEM Implants TSSystem and HiOssenImplants ET Systemimplants does not raisedifferent questions of safetyand effectiveness.Mechanical testing andengineering analysesdemonstrate equivalency. |
| Abutment Designs | Overdentureattachmentabutments | Overdentureattachment abutments | Equivalent |
| ProsthesisAttachment | Patrices-Matrices | Patrices-Matrices | Equivalent |
{14}------------------------------------------------
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
| Comparison | SubjectMedentikaMedentiLOC | K142167MedentikaMedentiLOC | Equivalence |
|---|---|---|---|
| Restoration | Multi-unit (full orpartial overdenture) | Multi-unit (full or partialoverdenture) | Equivalent |
| Implant-AbutmentPlatform Diameter(mm) | 3.5 - 7.0 | Equivalent | |
| Gingival Height (mm) | 1-5 | Equivalent | |
| Abutment Angulation(degrees) | Straight | Straight, 15° | Equivalent |
| Abutment &Abutment screwmaterials | Ti6Al4V, medicalgrade 5, conformingto ASTM F136Titanium nitridecoating onabutments | Ti6Al4V, medical grade5, conforming to ASTMF136Titanium nitride coatingon abutments | Equivalent |
| Sterilization | Supplied non-sterileMoist heat sterilizedby end user | Supplied non-sterileMoist heat sterilized byend 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 | SubjectMedentika Titanium bases | K170838Medentika Titanium bases | K150203Medentika Titanium bases | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications foruse | Medentika TiBase CAD/CAM Abutments are intended for use withdental implants as a support for single or multiple toothprostheses in the maxilla or mandible of a partially or fullyedentulous patient.Medentika TiBase is intended for use with the Straumann®CARES® System. All digitally designed copings and/or crownsare intended to be sent to Straumann for manufacture at avalidated milling center.Medentika abutments for the Nobel Biocare Nobel Active®3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0mmand TX®* 3.0mm implant bodies are indicated for maxillary lateraland 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 supportfor 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. | ||||||||||
| MedentikaSeries | Manufacturerof the implantsystem | Compatibleimplantsystem | ImplantDiameter(mm) | PlatformDiameter(mm) | ImplantSystemCombability | Series | ImplantDiameterr (mm) | PlatformDiameter(mm) | ImplantSystemCombability | Series | ImplantDiameter(mm) | PlatformDiameter(mm) | |
| EV-Series | DENTSPLYImplants | ASTRATECHOsseoSpeed® EV | 3.0 | 3.0 | NobelBiocareReplaceSelect | E | 3.5, 4.3,5.0, 6.0 | 3.5, 4.3,5.0, 6.0 | Nobel BiocareReplace™Select | E | 3.5, 4.3,5.0, 6.0 | 3.5, 4.3,5.0, 6.0 | |
| S-Series | DENTSPLYImplants | ASTRATECHOsseoSpeed®TX | 3.0 | 3.0 | Dentsply®Implants/ASTRA TECHOsseoSpeed® EV | EV | 3.6, 4.2,4.8, 5.4 | 3.6, 4.2,4.8, 5.4 | Nobel BiocareNobelActive™ | F | 3.5, 4.3,5.0 | 3.5,3.9(4.3),3.9 (5.0) | |
| F-Series | Nobel Biocare | NobelActive® CC | 3.0, 5.5 | 3.0, WP5.5 | NobelBiocareNobelActive | F | 3.5, 4.3,5.0 | 3.5,3.9(4.3),3.9 (5.0) | Biomet 3i®OsseotiteCertain® | H | 3.25, 4.0,5.0 | 3.4, 4.1,5.0 | |
| OT-Series | OSSTEMImplantHiOssenImplant | TS SystemET System | 3.5, 4.0,4.5, 5.0,6.0, 7.03.5, 4.0,4.5, 5.0,6.0, 7.0 | Mini,Regular | Biomet 3iOsseotite | H | 3.25, 4.0,5.0 | 3.4, 4.1,5.0 | Biomet 3iOsseotite® | I | 3.25, 3.75,4.0, 5.0 | 3.4, 4.1,5.0 | |
| Biomet 3iOsseotiteCertain | I | 3.25, 3.75,4.0, 5.0 | 3.4, 4.1,5.0 | Nobel BiocareBranemark | K | 3.3, 3.75,4.0, 5.0 | 3.5, 4.1,4.1, 5.1 | ||||||
| NobelBiocareBranemark | K | 3.3, 3.75,4.0, 5.0 | 3.5, 4.1,4.1, 5.1 | StraumannBone Level | L | 3.3, 4.1,4.8 | 3.3, 4.1,4.8 | ||||||
| StraumannBone Level | L | 3.3, 4.1,4.8 | 3.3, 4.1,4.8 | Straumann SoftTissue Level | N | 3.3, 4.1,4.8 | 3.5 (NNC),4.8, 6.5 | ||||||
| StraumannSoft TissueLevel | N | 3.3, 4.1,4.8 | 3.5 (NNC),4.8, 6.5 | Zimmer TaperedScrew-vent® | R | 3.3, 3.7,4.1, 4.7,6.0 | 3.5, 4.5,5.7 | ||||||
| ZimmerTaperedScrew-vent | R | 3.3, 3.7,4.1, 4.7,6.0 | 3.5, 4.5,5.7 | Astra TechOsseoSpeed™ | S | 3.5, 4.0,4.5, 5.0 | 3.5, 4.0,4.5, 5.0 | ||||||
| DenstplyFriadent®Frialit/XiVE® | T | 3.4, 3.8,4.5, 5.5 | 3.4, 3.8,4.5, 5.5 | ||||||||||
| DentsplyFiradent®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 TechOsseoSpeed | S | 3.5, 4.0,4.5, 5.0 | 3.5, 4.0,4.5, 5.0 | Medentika TiBase is intended for use with theStraumann® CARES® System. All digitally designedabutments for use with Medentika CAD/CAMAbutments are intended to be manufactured at aStraumann® CARES® validated milling center. | ||
|---|---|---|---|---|---|---|
| DentsplyFriadentFrialit/XiVE | T | 3.4, 3.8,4.5, 5.5 | 3.4, 3.8,4.5, 5.5 | |||
| DentsplyFriadentAnkylos | Y | 3.5, 4.5,5.5, 7.0 | 3.5, 4.5,5.5, 7.0 | Medentika TiBase is intended for use with theStraumann® CARES® System. All digitally designedcopings and/or crowns are intended to be sent toStraumann for manufacture at a validated millingcenter. |
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 | SubjectMedentika Titaniumbases | K170838MedentikaTitanium bases | K150203Medentika Titaniumbases | Equivalence |
|---|---|---|---|---|
| FDA product code | NHA | NHA | NHA | Equivalent |
| Series | EV, F, OT, S | E, EV, F, H, I, K, L,N, R, S, T, Y | E, F, H, I, K, L, N, R, S,T, Y | The OT series is a new series.Addition of abutmentscompatible with OSSTEMImplants TS System andHiOssen ET System implantsdoes not raise differentquestions of safety andeffectiveness. Mechanicaltesting and engineeringanalyses demonstrateequivalency. |
| Abutment Designs | Titanium Base 2ndGenerationTitanium Base AngledScrew Channel (ASC)Flex | Titanium Base 2ndGeneration | Titanium Base 1stGenerationTitanium Base 2ndGeneration | Equivalent |
| ProsthesisAttachment | Cement retained | Cement retained | Cement retained | Equivalent |
| Restoration | Single unit | Single unit | Single unit | Equivalent |
| Compatible ImplantBody Diameter(mm) | 3.0-7.0 | 3.3-6.0 | 3.3 -6.0 | Addition of abutmentscompatible with Ø3.0mm andØ7.0mm implants does notraise different questions ofsafety and effectiveness.Mechanical testing andengineering analysesdemonstrate equivalency. |
| Gingival Height (inthe Titanium base)(mm) | 0.65-1.2 | 0.1-1.15 | 0.1-1.15 | Equivalent |
| TitaniumComponentAngulation | Straight | Straight | Straight | Equivalent |
| Abutment &Abutment ScrewMaterials | Ti6Al4V, medical grade5, conforming to ASTMF136 | Ti6Al4V, medicalgrade 5,conforming toASTM F136 | Ti6Al4V, medicalgrade 5, conformingto ASTM F136 | Equivalent |
| Sterilization | Supplied non-sterileMoist heat sterilized byend user | Supplied non-sterileMoist heatsterilized by enduser | Supplied non-sterileMoist heat sterilized byend user | Equivalent |
| Usage- Allcomponents | Single-patient, single-use | Single-patient,single-use | Single-patient, single-use | Equivalent |
| Limits | ||||
| SuperstructureMaterial | Zirconia | Zirconia and IPSe.max CAD | Zirconia | Equivalent |
| Minimum wallthickness (mm) | 0.5 | 0.4(0.9 for IPS e.maxCAD) | 0.4 | Equivalent |
| Minimum abutmentpost height forsingle-unitrestorations (mm)(length above theabutmentcollar/gingivalheight) | 4.0 | 4.0 | 4.0 | Equivalent |
| Comparison | SubjectMedentika Titaniumbases | K170838MedentikaTitanium bases | K150203Medentika Titaniumbases | Equivalence |
| Minimum gingivalheight (mm) | 0.65 | 0.1 | 0.1 | Equivalent |
| Maximum height ofthe emergenceprofile (mm) | 5 | 5 | 5 | Equivalent |
| MaximumAbutmentAngulation(degrees) | $30°$ | $30°$ | $30°$ | Equivalent |
| Bonding cement | Multilink® HybridAbutment Cement byIvoclar VivadentK130436 | Multilink® HybridAbutment Cementby Ivoclar VivadentK130436 | Multilink® HybridAbutment Cement byIvoclar VivadentK130436 | Equivalent |
{18}------------------------------------------------
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
Table 5 – Comparative Summary of the Proposed and the Previously Cleared Medentika TiBase CAD/CAM Abutments
Medentika Preface CAD/CAM Abutments
The subject and existing Medentika Preface CAD/CAM abutments, ti-blank abutment as patient matched 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 6 includes the exact indications for use statements.
{19}------------------------------------------------
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
| Comparison | Medentika Preface CAD/CAM abutments | K150203 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Medentika Preface Abutments | |||||||||
| Indicationsfor use | Medentika Preface CAD/CAM Abutments are intended for use with dentalimplants as a support for single or multiple tooth protheses in the maxilla ormandible 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 Abutmentsare intended to be manufactured at a Straumann® CARES® validated millingcenter. The final patient matched form is a MedentiCAD abutment.Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral andmandibular central/lateral incisors only.Implant System Compatibility Series (Series / Implant System / Implantdiameter / Platform Diameters or Implant Connection): | Medentika Preface CAD/CAM Abutments are intended for use with dental implants as asupport for single or multiple tooth protheses in the maxilla or mandible of a partially orfully edentulous patient. | |||||||
| Implant SystemCombability | Series | Implant Diameter(mm) | Platform Diameter(mm) | ||||||
| MedentikaSeries ofthemedicaldevice | Manufacturer ofthe implantsystem | Compatibleimplantsystem | ImplantDiameter(mm) | PlatformDiameter(mm) | |||||
| E-Series | Nobel Biocare | Replace™Select | 6.0 | 6.0 | Nobel BiocareReplace™ Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 | |
| EV-Series | DENTSPLYImplants | ASTRATECHOsseoSpeed®EV | 3.0, 3.6,4.2, 4.8,5.4 | 3.0, 3.6,4.2, 4.8,5.4 | Nobel BiocareNobel Active™ | F | 3.0, 3.5, 4.3, 5.0 | 3.0, 3.5, 3.9(4.3), 3.9(5.0) | |
| F-Series | Nobel Biocare | NobelActive®CC | 5.5 | WP 5.5 | Biomet 3iOsseotite® Calcium® | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| OT-Series | OSSTEMImplantsHiOssenImplants | TS SystemET System | 3.5, 4.0,4.5, 5.0,6.0, 7.03.5, 4.0,4.5, 5.0,6.0, 7.0 | Mini,Regular | Biomet 3iOsseotite® | I | 3.25, 3.75, 4.0,5.0 | 3.4, 4.1, 5.0 | |
| Nobel BiocareBranemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 | ||||||
| Straumann BoneLevel | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | ||||||
| StraumannStandard | N | 3.3, 4.1, 4.8 | 3.5 (NNC), 4.8, 6.5 | ||||||
| Zimmer TaperedScrew-vent® | R | 3.3, 3.7, 4.1, 4.7,6.0 | 3.5, 4.5, 5.7 | ||||||
| Astra TechOsseoSpeed™ | S | 3.0, 3.5, 4.0, 4.5,5.0 | 3.0, 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 | ||||||
| Medentika Preface is intended for use with the Straumann® CARES® System. All digitallydesigned abutments for use with Medentika CAD/CAM Abutments are intended to bemanufactured at a Straumann® CARES® validated milling center. |
Table 6 – Comparison of the proposed and previously cleared indications for use for the Medentika Preface CAD/CAM abutments
{20}------------------------------------------------
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
The design limits of the subject Medentika Preface CAD/CAM abutments are consistent with that of the previously cleared Medentika Preface CAD/CAM abutments. A detailed comparison of the subject and previously cleared Medentika Preface CAD/CAM abutments is included in Table 7.
| Comparison | Medentika PrefaceCAD/CAM abutments | K150203Medentika PrefaceAbutments | Equivalence |
|---|---|---|---|
| FDA product code | NHA | NHA | Equivalent |
| Series | E, EV, F, OT | E, F, H, I, K, L, N, R, S, T | The EV and OT series are newseries. Addition of abutmentscompatible with OsseoSpeed EV,TS System, and ET Systemimplants does not raise differentquestions of safety andeffectiveness. Mechanical testingand engineering analysesdemonstrate equivalency. |
| Abutment Designs | Titanium blankØ11.5 and 16mm | Titanium blankØ11.5 and 16mm | Equivalent |
| Prosthesis Attachment | Cement retained | Cement retained | Equivalent |
| Restoration | Single unit | Single unit | Equivalent |
| Compatible ImplantBody Diameter (mm) | 3.0-7.0 | 3.0-6.5 | Addition of abutments compatiblewith Ø7.0mm implants does notraise different questions of safetyand effectiveness. Mechanicaltesting and engineering analysesdemonstrate equivalency. |
| Abutment & AbutmentScrew Materials | Ti6Al4V, medical grade 5,conforming to ASTMF136 | Ti6Al4V, medical grade 5,conforming to ASTMF136 | Equivalent |
| Sterilization | Supplied non-sterileMoist heat sterilized byend user | Supplied non-sterileMoist heat sterilized byend user | Equivalent |
| Usage- All components | Single-patient, single-use | Single-patient, single-use | Equivalent |
| Minimum wall thickness(mm) | 0.4 | 0.4 | Equivalent |
| Minimum gingivalheight in stockcomponent (mm) | 0.1-0.25 | 0.00-0.23 | EquivalentLabeling includes specificwarnings for gingival heights lessthan 0.5mm |
| Comparison | Medentika PrefaceCAD/CAM abutments | K150203Medentika PrefaceAbutments | Equivalence |
| Maximum height of theemergence profile (mm) | 5 | 5 | Equivalent |
| Max angulation(degrees) | 30° | 30° | Equivalent |
| Minimum abutmentpost height (mm)(length above theabutmentcollar/gingival height) | 4.0 | 4.0 | Equivalent |
{21}------------------------------------------------
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
Table 7 – Comparative Summary of the Proposed and Previously Cleared Medentika Preface
CAD/CAM abutments
{22}------------------------------------------------
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
Medentika Multi-unit abutments
The subject and existing multi-unit abutments are 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. Table 8 includes the exact indications for use statements.
| Comparison | SubjectMulti-unit Abutments | K191123Multi-unit Abutments | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Indicationsfor 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.Compatibility Series (Series / Implant System / Implant diameter / Platform Diameters or Implant Connection): | 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 ofthe medicaldevice | Manufacturerof the implantsystem | Compatibleimplantsystem | ImplantDiameters(mm) | PlatformDiameters(mm) | Medentikaseries | Medentika series | Implant diameter | Platform diameter | |
| EV-Series | Dentsply® Implants – ASTRA TECH OsseoSpeed® | 3.6, 4.2, 4.8 | 3.6, 4.2, 4.8 | ||||||
| E-Series | Nobel Biocare | ReplaceSelect™ | 3.5, 4.3, 5.0 | NP 3.5, RP 4.3, WP 5.0 | F-Series | Nobel Biocare Nobel Active –NobelReplace Conical | 3.5, 4.3, 5.0 | NP 3.5, RP 4.3/5.0 | |
| S-Series | DENTSPLYImplants | ASTRA TECHOsseoSpeed®TX | 3.5, 4.0,4.5, 5.0 | 3.5/4.3,4.5/5.0 | H-Series | Biomet 3i - Certain | 3.25, 4.0 | 3.4, 4.1 | |
| 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 | L-Series | Straumann - Bone Level | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | |
| OT-Series | OSSTEMImplantHiOssenImplant | TS SystemET System | 3.5, 4.0,4.5, 5.0,6.0, 7.03.5, 4.0,4.5, 5.0,6.0, 7.0 | Mini,Regular | 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 |
Table 8 – Comparison of the proposed and previously cleared indications for use for the Medentika multi-unit abutments
{23}------------------------------------------------
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
The design of the subject Medentika multi-unit abutments is consistent with that of the previously cleared Medentika multi-unit abutments. A detailed comparison of the subject and previously cleared multi-unit abutments is supplied in Table 9.
| Comparison | SubjectMulti-unit Abutments | K191123Multi-unit Abutments | Equivalence |
|---|---|---|---|
| FDA Product Code | NHA | NHA | Equivalent |
| Series | E, F, OT, S | EV, F, H, L, N, R | The E, OT, and S seriesare new series. Addition ofabutments compatible with,Replace Select, Astra TechOsseoSpeed TX, TSSystem, and ET Systemimplants do not raisedifferent questions ofsafety and effectiveness.Mechanical testing andengineering analysesdemonstrate equivalency. |
| Abutment Designs | Multi-unit abutments base forconstruction of bridge and barconstructs | Multi-unit abutments base forconstruction of bridge and barconstructs | Equivalent |
| Prosthesis Attachment | For prosthetic restorationCast-on procedures:Multi-unit Gold alloy cap castableCAD/CAM and traditionalworkflows:Multi-unit titanium baseCementable procedures:Multi-unit titanium capsBridge screwCover cap (temporary device) | For prosthetic restorationCast-on procedures:Multi-unit Cobalt chromium alloycap castableMulti-unit Gold alloy capcastableCAD/CAM and traditionalworkflows:Multi-unit titanium baseCementable procedures:Multi-unit titanium capsBridge screwCover cap (temporary device) | Equivalent |
| Restoration | Multi-unit | Multi-unit | Equivalent |
| Implant-AbutmentPlatform Diameter(mm) | 3.5-7.0 | 3.25 - 5 | Addition of abutmentscompatible with Ø7.0mmTS and ET Systemimplants do not raisedifferent questions ofsafety and effectiveness.Mechanical testingdemonstrates equivalency. |
| Gingival Height (mm) | 0.6-5.5 | 0.6-5.5 | Equivalent |
| Abutment Angulation(degrees) | Straight, 17°, 30° | Straight, 17°, 30° | Equivalent |
| Abutment & AbutmentScrew Materials | Ti6Al4V, medical grade 5,conforming to ASTM F136 | Ti6Al4V, medical grade 5,conforming to ASTM F136 | Equivalent |
| Comparison | SubjectMulti-unit Abutments | K191123Multi-unit Abutments | Equivalence |
| Sterilization | Supplied sterileGamma irradiation | Supplied sterileGamma irradiation | Equivalent |
| Usage | Single-patient, single-use | Single-patient, single-use | Equivalent |
| Packaging | Medical grade polyethylene blisterwith a sealing lid | Medical grade polyethyleneblister with a sealing lid | Equivalent |
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Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
Table 9 - Comparative Summary of the Proposed and Previously Cleared Medentika Multi-unit abutment
Materials
The subject abutments are manufactured from Ti6Al4V, medical grade 5, conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications. The multi-unit gold alloy castable caps are manufactured from gold alloy which meets applicable requirements defined in ISO 22674, Dentistry - Metallic materials for fixed and removable restorations and appliances. The MedentiLOC abutments have a titanium nitride coating.
Performance Testing
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence in this 510(k) includes:
- . Dynamic fatigue testing according to 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 ISO 14801 Dentistry - implants dynamic loading test for endosseous dental implants,
- Dimensional analysis and reverse engineering of the implant-to-abutment connection . platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible OEM implant body, OEM abutment, and OEM fixation screw. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.
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Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
- Referenced from K191123 was steam sterilization validation according to ISO 17665-1: . Sterilization of health care products - Moist heat - Part 1: Development, validation and routine control of a sterilization process for medical devices and ISO/TS 17665-2: Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1,
- . Referenced from K191123 was gamma irradiation validation according to ISO 11137-1: Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, and ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose,
- Referenced from K191123 was sterile packaging validation in accordance with ISO 11607-. 1: Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2 Packaging for terminally sterilized medical devices- Part 2: Validation requirements for forming, sealing and assembly processes and,
- Referenced from K142167, K170838, K191123, K150203 and K061804 were . biocompatibility evaluations in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- Referenced from K180564 was MR testing in accordance with ASTM F2052-15, ASTM . F2213-06 (2011), ASTM F2182-11a and ASTM F2119-13.
Conclusion
The data included in this submission demonstrate substantial equivalence to the predicate device listed above. Performance testing and comparison to previous clearances show that the subject devices are substantially equivalent.
§ 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.)