(560 days)
No
The document describes dental abutments and their compatibility with various implant systems. There is no mention of AI or ML in the intended use, device description, or performance studies. The CAD/CAM aspect refers to digital design and manufacturing, not AI/ML-driven processes.
Yes.
The device acts as a support for dental prostheses, which is intended to restore or replace missing dental structures and thus alleviate a medical condition.
No
This device, Medentika abutments, is described as a support for dental prostheses with dental implants. Its intended use and device description focus on restorative dental procedures, not on diagnosing medical conditions.
No
The device description explicitly lists physical components such as "abutments, abutment screws, caps, and bases," which are hardware. The performance studies also focus on physical properties like fatigue testing and dimensional analysis.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a support for dental prostheses in the maxilla or mandible. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details physical components like abutments, screws, caps, and bases, and their compatibility with dental implant systems. This aligns with a medical device used for structural support, not a diagnostic tool.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The device is a dental implant component, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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 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).
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K150203, K170838, K191123, K130999, K120414, K101732, K121995, K161604, K140934, K142260, K020646, K061410, K073142
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Medentika GmbH % Jennifer Jackson Sr. Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
April 15, 2024
Re: K223113
Trade/Device Name: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 9, 2024 Received: April 10, 2024
Dear Jennifer Jackson:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
Medentika Abutment System
Indications for Use (Describe)
Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Implant System Compatibility Series / Implant System / Implant diameter / Platform Diameters or Implant Connection): Standard Abutment:
| Medentika
series of the
medical
device | Manufacturer of
the implant
system | Compatible Implant
system | Implant Diameters
(mm) | Platform
Diameters (mm) |
|-------------------------------------------------|------------------------------------------|------------------------------|----------------------------|----------------------------|
| EV-Series | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed® EV | 3.0, 3.6, 4.2, 4.8,
5.4 | 3.0, 3.6, 4.2, 4.8,
5.4 |
| S-Series | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed® TX | 3.0 | 3.0 |
| R-Series | ZimVie | Tapered Screw-Vent® | 3.3, 3.7, 4.1, 4.7,
6.0 | 3.5, 4.5, 5.7 |
Temporary Abutment:
| Medentika
series of the
medical
device | Manufacturer of
the implant
system | Compatible Implant
system | Implant Diameters
(mm) | Platform
Diameters (mm) |
|-------------------------------------------------|------------------------------------------|------------------------------|---------------------------------|----------------------------|
| S-Series | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed® TX | 3.0 | 3.0 |
| Medentika
series of the
medical
device | Manufacturer of
the implant
system | Compatible Implant
system | Implant Diameters
(mm) | Platform
Diameters (mm) |
| OT-Series | OSSTEM Implant
HiOssen Implant | TS System | 3.5, 4.0, 4.5, 5.0,
6.0, 7.0 | Mini, Regular |
| | | ET-System | 3.5, 4.0, 4.5, 5.0,
6.0, 7.0 | |
MedentiLOC Abutment:
Type of Use (Select one or both, as applicable)
�Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
PSC Publishing Services (301) 443-6740 EF
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Medentika CAD/CAM TiBases
Indications for Use (Describe)
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.
Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Implant System Compatibility Series / Implant System / Implant diameter / Platform Diameters or Implant Connection):
| Medentika series
of the medical
device | Manufacturer of
the implant
system | Compatible implant
system | Implant Diameters
(mm) | Platform
Diameters
(mm) |
|----------------------------------------------|------------------------------------------|------------------------------|---------------------------------|-------------------------------|
| EV-Series | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed® EV | 3.0 | 3.0 |
| F-Series | Nobel Biocare | NobelActive® CC | 3.0, 5.5 | 3.0, WP 5.5 |
| OT-Series | OSSTEM Implant
HiOssen Implant® | TS-System
ET-System | 3.5, 4.0, 4.5, 5.0,
6.0, 7.0 | Mini, Regular |
| S-Series | Dentsply Implants | ASTRA TECH
OsseoSpeed® TX | 3.0 | 3.0 |
Type of Use (Select one or both, as applicable)
図Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
6
| FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |
| Food and Drug Administration | Expiration Date: 06/30/2023 | |
| Indications for Use | See PRA Statement below. | |
| 510(k) Number (if known) |
K223113
Device Name Medentika CAD/CAM Abutments
Medcutiika CAD/CAM Abutment
Indications for Use (Describe)
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Implant System Compatibility Series / Implant System / Implant diameter / Platform Diameters or Implant Connection):
| Medentika
series of the
medical device | Manufacturer of
the implant
system | Compatible implant
system | Implant Diameters
(mm) | Platform
Diameters (mm) |
|----------------------------------------------|------------------------------------------|------------------------------|---------------------------------|----------------------------|
| E-Series | Nobel Biocare | Replace™ Select | 6.0 | 6.0 |
| EV-Series | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed® EV | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8,
5.4 |
| F-Series | Nobel Biocare | NobelActive® CC | 5.5 | WP 5.5 |
| OT-Series | OSSTEM Implant
HiOssen Implant® | TS-System
ET-System | 3.5, 4.0, 4.5, 5.0, 6.0,
7.0 | Mini, Regular |
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D) □Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
PSC Publishing Services (301) 443-6740 EF
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K223113
Device Name
Medentika Multi-unit Abutments
Indications for Use (Describe)
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
lmplant System Compatibility Series / Implant System / Implant diameter / Platform Diameters or Implant Connection):
| Medentika Series
of the medical
device | Manufacturer
of the implant
system | Compatible
implant system | Implant Diameters (mm) | Platform
Diameters
(mm) |
|----------------------------------------------|------------------------------------------|-----------------------------------------|--------------------------------------------------------------|----------------------------------|
| E-Series | Nobel Biocare | Replace Select™ | 3.5, 4.3, 5.0 | NP 3.5, RP
4.3, WP 5.0 |
| S-Series | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed® TX | 3.5, 4.0, 4.5, 5.0 | 3.5/4.3,
4.5/5.0 |
| F-Series | Nobel Biocare | NobelActive® CC,
NobelReplace®
CC | 3.5, 4.3, 5.0, 5.5 | NP 3.5, RP
4.3/5.0, WP
5.5 |
| OT-Series | OSSTEM
Implant
HiOssen Implant | TS System
ET System | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0
3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | Mini, Regular |
Type of Use (Select one or both, as applicable)
図Prescription Use (Part 21 CFR 801 Subpart D) □Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20) 6740 EF
PSC Publishing Services (301) 443-
8
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of Medentika GmbH)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052
On the behalf of:
Medentika GmbH
Hammweg, 8-10
76549 Hügelsheim, Germany |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS, RAC
Sr. Director, Regulatory Affairs and Quality
Phone Number: +1 978 747-2509
Fax Number: +1 978 747-0023 |
| Prepared By &
Alternate Contact: | Nadia Fouladi
Head of Regulatory Affairs International
Medentika GmbH
Phone number: +4972296991210 |
| Date Prepared: | April 15, 2024 |
Name of the Device
| Trade Names: | Medentika Abutment System, Medentika CAD/CAM
Abutments, Medentika CAD/CAM TiBases, Medentika
Multi-unit Abutments |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR §872.3630 |
| Device Classification: | II |
9
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
Product Code(s): NHA
Classification Panel: Dental
Predicate and Reference Device(s)
Primary Predicate:
-
. K142167 – Medentika Abutment System
Reference Devices for Abutments: -
K150203 Medentika CAD/CAM Abutments .
-
. K170838 – Medentika CAD/CAM TiBases
-
K191123 Medentika Multi-Unit Abutment .
Reference Devices to support added compatible implants:
- . K130999 and K120414 - OsseoSpeed EV
- K101732 OsseoSpeed TX ●
- K121995 and K161604 TS System ●
- K140934 – ET System
- K142260 NobelActive .
- K020646 – Nobel Replace
- . K061410 - Tapered Screw-Vent
- K073142 – NobelReplace CC
Device Description
The Medentika abutments include abutments, abutment screws, caps, and bases which are labelled under a specific Medentika series and are compatible with a specified dental implant system. The abutments include sinqle-unit abutments intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. The abutments also include multi-unit abutments
10
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
The purpose of this premarket notification is to add additional abutments. The subject abutments include abutments compatible with additional dental implant systems forming a new Medentika series (the OT series). The subject abutments also include abutments compatible with new implant diameters in existing Medentika series (E, EV, F, and S). Lastly, the subject abutments include new abutment designs compatible with existing implant diameters in existing Medentika series (R).
Indications for Use and Summary of Similarities and Differences in Technological Characteristics, Performance Testing, and Intended Use
Medentika Standard and Temporary Abutments
The subject and existing Medentika standard and temporary abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Table 1 includes the exact indications for use statements.
11
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
| Comparison | Subject
Medentika Abutments - Standard abutment, temporary abutments, and MedentiLOC abutments | | | | K142167
Medentika Abutment System | | | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------|------------------------------------------------|
| Indications for use | Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Implant System Compatibility Series (Series / Implant System / Implant diameter / Platform Diameters or Implant connection): | | | | Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Abutments are compatible with the following implant systems:
Implant System | Series | Implant
Diameters
(mm) | |
| | Standard Abutment:
Medentika
series of the | Manufacturer
of the implant
system | Compatible Implant
system | Implant
Diameters
(mm) | Platform
Diameters
(mm) | Nobel Biocare Replace
Select | E-
Series | 3.5, 4.3, 5.0,
6.0 |
| | medical device
EV-Series | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed® EV | 3.0, 3.6, 4.2,
4.8, 5.4 | 3.0, 3.6,
4.2, 4.8, 5.4 | Nobel Biocare
NobelActive | F-
Series | 3.5, 4.3, 5.0 |
| | S-Series | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed® TX | 3.0 | 3.0 | Biomet 3i Osseotite®
Certain | H-
Series | 3.25, 4.0, 5.0 |
| | R-Series | ZimVie | Tapered Screw-Vent® | 3.3, 3.7, 4.1,
4.7, 6.0 | 3.5, 4.5, 5.7 | Biomet 3i Osseotite | I-
Series | 3.25, 3.75, 4.0,
5.0 |
| | Temporary Abutment:
Medentika
series of the | Manufacturer
of the implant
system | Compatible Implant
system | Implant
Diameters
(mm) | Platform
Diameters
(mm) | Nobel Biocare
Branemark
Straumann Bone Level | K-
Series
L-
Series | 3.3, 3.75, 4.0,
5.0
3.3, 4.1, 4.8 |
| | medical device | | | | | Straumann Standard | N-
Series | 3.3, 4.1, 4.8 |
| | S-Series | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed® TX | 3.0 | 3.0 | Zimmer Tapered
Screw-vent | R-
Series | 3.3, 3.7, 4.1,
4.7, 6.0 |
| | MedentiLOC Abutment:
Medentika
series of the
medical device | Manufacturer
of the implant
system | Compatible Implant
system | Implant
Diameters
(mm) | Platform
Diameters
(mm) | Astra Tech
OsseoSpeed | S-
Series | 3.5, 4.0, 4.5,
5.0 |
| | | | | | | Denstply Friadent
Frialit/XiVE
Dentsply Firadent
Ankylos | T-
Series
Y-
Series | 3.4, 3.8, 4.5,
5.5
3.5, 4.5, 5.5,
7.0 |
| | OT-Series | OSSTEM
Implant
HiOssen
Implant | TS System
ET-System | 3.5, 4.0, 4.5,
5.0, 6.0, 7.0
3.5, 4.0, 4.5,
5.0, 6.0, 7.0 | Mini,
Regular | | | |
Table 1 – Comparison of the Proposed and Previously Cleared Indications for use for the Medentika Standard and Temporary Abutments.
12
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
The design of the subject Medentika standard and temporary abutments is consistent with that of the previously cleared Medentika standard and temporary abutments. A detailed comparison of the subject and previously cleared Medentika standard and temporary abutments is included in Table 1.
| Comparison | Subject
Medentika
abutments | K142167
Medentika
abutment system | Equivalence |
|----------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product
Code | NHA | NHA | Equivalent |
| Series | R, S, EV | E, F, H, I, K, L, N,
R. S. T | The EV series is a new series. Addition of
abutments compatible with OsseoSpeed
EV implants does not raise different
questions of safety and effectiveness.
Mechanical testing and engineering
analyses demonstrate equivalency. |
| Abutment
Designs | Standard
abutment
Temporary
abutment | Standard abutment
Temporary
abutment | Equivalent |
| Prosthesis
Attachment | Cement retained | Cement retained | Equivalent |
| Restoration | Single unit | Single unit | Equivalent |
| Compatible
Implant Body
Diameter (mm) | 3.0-5.7 | 3.5-6 | Addition of abutments compatible with
Ø3.0mm implants do not raise different
questions of safety and effectiveness.
Mechanical testing and engineering
analyses demonstrate equivalency. |
| Gingival
Height (mm) | 1-3.5 | 1-3 | The increase in gingival height does not
raise different questions of safety and
effectiveness. Mechanical testing and
engineering analyses demonstrate
equivalency. |
| Abutment
Angulation
(degrees) | Straight, 16°,
18° | Straight, 16°, 18°,
21° | Equivalent |
| Abutment &
Abutment
Screw
Materials | Ti6Al4V, medical
grade 5,
conforming to
ASTM F136 | Ti6Al4V, medical
grade 5,
conforming to
ASTM F136 | Equivalent |
13
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
| Comparison | Subject
Medentika
abutments | K142167
Medentika
abutment system | Equivalence |
|---------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-------------|
| Sterilization | Supplied non-
sterile
Moist heat
sterilized by end
user | Supplied non-
sterile
Moist heat
sterilized by end
user | Equivalent |
| Usage | Single-patient,
single-use | Single-patient,
single-use | Equivalent |
510(k) Summary
Table 2 – Comparative Summary of the Proposed and the Previously Cleared Medentika Standard and Temporary Abutments
The Medentika MedentiLOC abutments are also part of the Medentika standard and temporary grouping of abutments. These abutments are designed for overdenture attachments. The design of the subject MedentiLOC abutments is consistent with that of the previously cleared MedentiLOC abutments. A detailed comparison of the subject and previously cleared MedentiLOC abutments is supplied in Table 3.
| Comparison | Subject
Medentika
MedentiLOC | K142167
Medentika
MedentiLOC | Equivalence |
|--------------------------|----------------------------------------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product Code | NHA | NHA | Equivalent |
| Series | OT | E, F, H, I, K, L, N, R, S,
T, Y | The OT series is a new
series. Addition of
abutments compatible with
OSSTEM Implants TS
System and HiOssen
Implants ET System
implants does not raise
different questions of safety
and effectiveness.
Mechanical testing and
engineering analyses
demonstrate equivalency. |
| Abutment Designs | Overdenture
attachment
abutments | Overdenture
attachment abutments | Equivalent |
| Prosthesis
Attachment | Patrices-Matrices | Patrices-Matrices | Equivalent |
14
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
| Comparison | Subject
Medentika
MedentiLOC | K142167
Medentika
MedentiLOC | Equivalence |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------|
| Restoration | Multi-unit (full or
partial overdenture) | Multi-unit (full or partial
overdenture) | Equivalent |
| Implant-Abutment
Platform Diameter
(mm) | 3.5 - 7.0 | | Equivalent |
| Gingival Height (mm) | 1-5 | | Equivalent |
| Abutment Angulation
(degrees) | Straight | Straight, 15° | Equivalent |
| Abutment &
Abutment screw
materials | Ti6Al4V, medical
grade 5, conforming
to ASTM F136
Titanium nitride
coating on
abutments | Ti6Al4V, medical grade
5, conforming to ASTM
F136
Titanium nitride coating
on abutments | Equivalent |
| Sterilization | Supplied non-sterile
Moist heat sterilized
by end user | Supplied non-sterile
Moist heat sterilized by
end user | Equivalent |
| Usage | Single-patient,
single-use | Single-patient, single-
use | Equivalent |
510(k) Summary
Table 3 - Comparative Summary of the Proposed and Previously Cleared MedentiLOC Abutments (part of the standard and temporary abutments grouping)
Medentika CAD/CAM TiBases
The subject and existing Medentika TiBase CAD/CAM abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla of a partially or fully edentulous patient. The two-piece abutment which compose the final abutment consists of the pre-manufactured titanium base component composed of titanium alloy and the CAD/CAM patient matched mesostructured (or superstructure) composed of zirconia. The CAD/CAM patient matched mesostructure (or superstructure) composed of zirconia is intended to be cemented to the pre-manufactured titanium base using Multilink® Hybrid Abutment Cement by Ivoclar Vivadent (K130436).
Table 4 includes the exact indications for use statements.
15
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
| Comparison | Subject
Medentika Titanium bases | | | K170838
Medentika Titanium bases | | | | K150203
Medentika Titanium bases | | | | | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------------|--------|-------------------------------|--------------------------------|
| Indications for
use | Medentika TiBase CAD/CAM Abutments are intended for use with
dental implants as a support for single or multiple tooth
prostheses in the maxilla or mandible of a partially or fully
edentulous patient.
Medentika TiBase is intended for use with the Straumann®
CARES® System. All digitally designed copings and/or crowns
are intended to be sent to Straumann for manufacture at a
validated milling center.
Medentika abutments for the Nobel Biocare Nobel Active®*
3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm
and TX®* 3.0mm implant bodies are indicated for maxillary lateral
and mandibular central/lateral incisors only.
Implant System Compatibility Series (Series / Implant System /
Implant diameter / Platform Diameters or Implant Connection): | | | Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support
for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | | | | Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | | | | | |
| | Medentika
Series | Manufacturer
of the implant
system | Compatible
implant
system | Implant
Diameter
(mm) | Platform
Diameter
(mm) | Implant
System
Combability | Series | Implant
Diameter
r (mm) | Platform
Diameter
(mm) | Implant
System
Combability | Series | Implant
Diameter
(mm) | Platform
Diameter
(mm) |
| | EV-Series | DENTSPLY
Implants | ASTRA
TECH
OsseoSpeed
® EV | 3.0 | 3.0 | Nobel
Biocare
Replace
Select | E | 3.5, 4.3,
5.0, 6.0 | 3.5, 4.3,
5.0, 6.0 | Nobel Biocare
Replace™
Select | E | 3.5, 4.3,
5.0, 6.0 | 3.5, 4.3,
5.0, 6.0 |
| | S-Series | DENTSPLY
Implants | ASTRA
TECH
OsseoSpeed
®TX | 3.0 | 3.0 | Dentsply®
Implants/AS
TRA TECH
OsseoSpeed
® EV | EV | 3.6, 4.2,
4.8, 5.4 | 3.6, 4.2,
4.8, 5.4 | Nobel Biocare
NobelActive™ | F | 3.5, 4.3,
5.0 | 3.5,
3.9(4.3),
3.9 (5.0) |
| | F-Series | Nobel Biocare | Nobel
Active® CC | 3.0, 5.5 | 3.0, WP
5.5 | Nobel
Biocare
NobelActive | F | 3.5, 4.3,
5.0 | 3.5,
3.9(4.3),
3.9 (5.0) | Biomet 3i®
Osseotite
Certain® | H | 3.25, 4.0,
5.0 | 3.4, 4.1,
5.0 |
| | OT-Series | OSSTEM
Implant
HiOssen
Implant | TS System
ET System | 3.5, 4.0,
4.5, 5.0,
6.0, 7.0
3.5, 4.0,
4.5, 5.0,
6.0, 7.0 | Mini,
Regular | Biomet 3i
Osseotite | H | 3.25, 4.0,
5.0 | 3.4, 4.1,
5.0 | Biomet 3i
Osseotite® | I | 3.25, 3.75,
4.0, 5.0 | 3.4, 4.1,
5.0 |
| | | | | | | Biomet 3i
Osseotite
Certain | I | 3.25, 3.75,
4.0, 5.0 | 3.4, 4.1,
5.0 | Nobel Biocare
Branemark | K | 3.3, 3.75,
4.0, 5.0 | 3.5, 4.1,
4.1, 5.1 |
| | | | | | | Nobel
Biocare
Branemark | K | 3.3, 3.75,
4.0, 5.0 | 3.5, 4.1,
4.1, 5.1 | Straumann
Bone Level | L | 3.3, 4.1,
4.8 | 3.3, 4.1,
4.8 |
| | | | | | | Straumann
Bone Level | L | 3.3, 4.1,
4.8 | 3.3, 4.1,
4.8 | Straumann Soft
Tissue Level | N | 3.3, 4.1,
4.8 | 3.5 (NNC),
4.8, 6.5 |
| | | | | | | Straumann
Soft Tissue
Level | N | 3.3, 4.1,
4.8 | 3.5 (NNC),
4.8, 6.5 | Zimmer Tapered
Screw-vent® | R | 3.3, 3.7,
4.1, 4.7,
6.0 | 3.5, 4.5,
5.7 |
| | | | | | | Zimmer
Tapered
Screw-vent | R | 3.3, 3.7,
4.1, 4.7,
6.0 | 3.5, 4.5,
5.7 | Astra Tech
OsseoSpeed™ | S | 3.5, 4.0,
4.5, 5.0 | 3.5, 4.0,
4.5, 5.0 |
| | | | | | | | | | | Denstply
Friadent®
Frialit/XiVE® | T | 3.4, 3.8,
4.5, 5.5 | 3.4, 3.8,
4.5, 5.5 |
| | | | | | | | | | | Dentsply
Firadent®
Ankylos® | Y | 3.5, 4.5,
5.5, 7.0 | 3.5, 4.5,
5.5, 7.0 |
16
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
| | | Astra Tech
OsseoSpeed | S | 3.5, 4.0,
4.5, 5.0 | 3.5, 4.0,
4.5, 5.0 | Medentika TiBase is intended for use with the
Straumann® CARES® System. All digitally designed
abutments for use with Medentika CAD/CAM
Abutments are intended to be manufactured at a
Straumann® CARES® validated milling center. |
|--|--|--------------------------------------|---|-----------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Dentsply
Friadent
Frialit/XiVE | T | 3.4, 3.8,
4.5, 5.5 | 3.4, 3.8,
4.5, 5.5 | |
| | | Dentsply
Friadent
Ankylos | Y | 3.5, 4.5,
5.5, 7.0 | 3.5, 4.5,
5.5, 7.0 | Medentika TiBase is intended for use with the
Straumann® CARES® System. All digitally designed
copings and/or crowns are intended to be sent to
Straumann for manufacture at a validated milling
center. |
510(k) Summary
Table 4 – Comparison of the proposed and previously cleared indications for use for the Medentika Ti Base CAD/CAM abutments
17
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
510(k) Summary
The design of the subject Medentika TiBase CAD/CAM abutments is consistent with that of the previously cleared Medentika TiBase CAD/CAM abutments. A detailed comparison of the subject and previously cleared Medentika TiBase CAD/CAM abutments is included in Table 5.
| Comparison | Subject
Medentika Titanium
bases | K170838
Medentika
Titanium bases | K150203
Medentika Titanium
bases | Equivalence |
|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 abutments
compatible with OSSTEM
Implants TS System and
HiOssen ET System implants
does not raise different
questions of safety and
effectiveness. Mechanical
testing and engineering
analyses demonstrate
equivalency. |
| Abutment Designs | Titanium Base 2nd
Generation
Titanium Base Angled
Screw Channel (ASC)
Flex | Titanium Base 2nd
Generation | Titanium Base 1st
Generation
Titanium Base 2nd
Generation | Equivalent |
| Prosthesis
Attachment | Cement retained | Cement retained | Cement retained | Equivalent |
| Restoration | Single unit | Single unit | Single unit | Equivalent |
| Compatible Implant
Body Diameter
(mm) | 3.0-7.0 | 3.3-6.0 | 3.3 -6.0 | Addition of abutments
compatible with Ø3.0mm and
Ø7.0mm implants does not
raise different questions of
safety and effectiveness.
Mechanical testing and
engineering analyses
demonstrate equivalency. |
| Gingival Height (in
the Titanium base)
(mm) | 0.65-1.2 | 0.1-1.15 | 0.1-1.15 | Equivalent |
| Titanium
Component
Angulation | Straight | Straight | Straight | Equivalent |
| Abutment &
Abutment Screw
Materials | Ti6Al4V, medical grade
5, conforming to ASTM
F136 | Ti6Al4V, medical
grade 5,
conforming to
ASTM F136 | Ti6Al4V, medical
grade 5, conforming
to ASTM F136 | Equivalent |
| Sterilization | Supplied non-sterile
Moist heat sterilized by
end user | Supplied non-
sterile
Moist heat
sterilized by end
user | Supplied non-sterile
Moist heat sterilized by
end user | Equivalent |
| Usage- All
components | Single-patient, single-
use | Single-patient,
single-use | Single-patient, single-
use | Equivalent |
| Limits | | | | |
| Superstructure
Material | Zirconia | Zirconia and IPS
e.max CAD | Zirconia | Equivalent |
| Minimum wall
thickness (mm) | 0.5 | 0.4
(0.9 for IPS e.max
CAD) | 0.4 | Equivalent |
| Minimum abutment
post height for
single-unit
restorations (mm)
(length above the
abutment
collar/gingival
height) | 4.0 | 4.0 | 4.0 | Equivalent |
| Comparison | Subject
Medentika Titanium
bases | K170838
Medentika
Titanium bases | K150203
Medentika Titanium
bases | Equivalence |
| Minimum gingival
height (mm) | 0.65 | 0.1 | 0.1 | Equivalent |
| Maximum height of
the emergence
profile (mm) | 5 | 5 | 5 | Equivalent |
| Maximum
Abutment
Angulation
(degrees) | $30°$ | $30°$ | $30°$ | Equivalent |
| Bonding cement | Multilink® Hybrid
Abutment Cement by
Ivoclar Vivadent
K130436 | Multilink® Hybrid
Abutment Cement
by Ivoclar Vivadent
K130436 | Multilink® Hybrid
Abutment Cement by
Ivoclar Vivadent
K130436 | 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 | |||||||||
| Indications | |||||||||
| for use | Medentika Preface CAD/CAM Abutments are 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. | |||||||||
| 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 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 Preface CAD/CAM Abutments are 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. | |||||||||
| Implant System | |||||||||
| Combability | Series | Implant Diameter | |||||||
| (mm) | Platform Diameter | ||||||||
| (mm) | |||||||||
| Medentika | |||||||||
| Series of | |||||||||
| the | |||||||||
| medical | |||||||||
| device | Manufacturer of | ||||||||
| the implant | |||||||||
| system | Compatible | ||||||||
| implant | |||||||||
| system | Implant | ||||||||
| Diameter | |||||||||
| (mm) | Platform | ||||||||
| Diameter | |||||||||
| (mm) | |||||||||
| E-Series | Nobel Biocare | Replace™ | |||||||
| Select | 6.0 | 6.0 | Nobel Biocare | ||||||
| Replace™ Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 | ||||||
| EV-Series | DENTSPLY | ||||||||
| Implants | ASTRA | ||||||||
| TECH | |||||||||
| OsseoSpeed® | |||||||||
| EV | 3.0, 3.6, | ||||||||
| 4.2, 4.8, | |||||||||
| 5.4 | 3.0, 3.6, | ||||||||
| 4.2, 4.8, | |||||||||
| 5.4 | Nobel Biocare | ||||||||
| Nobel 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 3i | ||||||
| Osseotite® Calcium® | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | ||||||
| OT-Series | OSSTEM | ||||||||
| Implants | |||||||||
| HiOssen | |||||||||
| Implants | TS System | ||||||||
| ET System | 3.5, 4.0, | ||||||||
| 4.5, 5.0, | |||||||||
| 6.0, 7.0 | |||||||||
| 3.5, 4.0, | |||||||||
| 4.5, 5.0, | |||||||||
| 6.0, 7.0 | Mini, | ||||||||
| Regular | Biomet 3i | ||||||||
| Osseotite® | I | 3.25, 3.75, 4.0, | |||||||
| 5.0 | 3.4, 4.1, 5.0 | ||||||||
| Nobel Biocare | |||||||||
| Branemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 | ||||||
| Straumann Bone | |||||||||
| Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | ||||||
| Straumann | |||||||||
| Standard | N | 3.3, 4.1, 4.8 | 3.5 (NNC), 4.8, 6.5 | ||||||
| Zimmer Tapered | |||||||||
| Screw-vent® | R | 3.3, 3.7, 4.1, 4.7, | |||||||
| 6.0 | 3.5, 4.5, 5.7 | ||||||||
| Astra Tech | |||||||||
| OsseoSpeed™ | 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 digitally | |||||||||
| designed abutments for use with Medentika CAD/CAM Abutments are intended to be | |||||||||
| manufactured 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 Preface
CAD/CAM abutments | K150203
Medentika Preface
Abutments | 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 new
series. Addition of abutments
compatible with OsseoSpeed EV,
TS System, and ET System
implants does not raise different
questions of safety and
effectiveness. Mechanical testing
and engineering analyses
demonstrate equivalency. |
| Abutment Designs | Titanium blank
Ø11.5 and 16mm | Titanium blank
Ø11.5 and 16mm | Equivalent |
| Prosthesis Attachment | Cement retained | Cement retained | Equivalent |
| Restoration | Single unit | Single unit | Equivalent |
| Compatible Implant
Body Diameter (mm) | 3.0-7.0 | 3.0-6.5 | Addition of abutments compatible
with Ø7.0mm implants does not
raise different questions of safety
and effectiveness. Mechanical
testing and engineering analyses
demonstrate equivalency. |
| Abutment & Abutment
Screw Materials | Ti6Al4V, medical grade 5,
conforming to ASTM
F136 | Ti6Al4V, medical grade 5,
conforming to ASTM
F136 | Equivalent |
| Sterilization | Supplied non-sterile
Moist heat sterilized by
end user | Supplied non-sterile
Moist heat sterilized by
end user | Equivalent |
| Usage- All components | Single-patient, single-
use | Single-patient, single-
use | Equivalent |
| Minimum wall thickness
(mm) | 0.4 | 0.4 | Equivalent |
| Minimum gingival
height in stock
component (mm) | 0.1-0.25 | 0.00-0.23 | Equivalent
Labeling includes specific
warnings for gingival heights less
than 0.5mm |
| Comparison | Medentika Preface
CAD/CAM abutments | K150203
Medentika Preface
Abutments | Equivalence |
| Maximum height of the
emergence profile (mm) | 5 | 5 | Equivalent |
| Max angulation
(degrees) | 30° | 30° | Equivalent |
| Minimum abutment
post height (mm)
(length above the
abutment
collar/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 | Subject
Multi-unit Abutments | | | | | K191123
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.
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: | | | |
| | Medentika
Series of
the medical
device | Manufacturer
of the implant
system | Compatible
implant
system | Implant
Diameters
(mm) | Platform
Diameters
(mm) | Medentika
series | 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 | Replace
Select™ | 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 | DENTSPLY
Implants | ASTRA TECH
OsseoSpeed®
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 | OSSTEM
Implant
HiOssen
Implant | TS System
ET System | 3.5, 4.0,
4.5, 5.0,
6.0, 7.0
3.5, 4.0,
4.5, 5.0,
6.0, 7.0 | Mini,
Regular | 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 | Subject
Multi-unit Abutments | K191123
Multi-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 series
are new series. Addition of
abutments compatible with,
Replace Select, Astra Tech
OsseoSpeed TX, TS
System, and ET System
implants do not raise
different questions of
safety and effectiveness.
Mechanical testing and
engineering analyses
demonstrate equivalency. |
| Abutment Designs | Multi-unit abutments base for
construction of bridge and bar
constructs | Multi-unit abutments base for
construction of bridge and bar
constructs | Equivalent |
| Prosthesis Attachment | For prosthetic restoration
Cast-on procedures:
Multi-unit Gold alloy cap castable
CAD/CAM and traditional
workflows:
Multi-unit titanium base
Cementable procedures:
Multi-unit titanium caps
Bridge screw
Cover cap (temporary device) | For prosthetic restoration
Cast-on procedures:
Multi-unit Cobalt chromium alloy
cap castable
Multi-unit Gold alloy cap
castable
CAD/CAM and traditional
workflows:
Multi-unit titanium base
Cementable procedures:
Multi-unit titanium caps
Bridge screw
Cover cap (temporary device) | Equivalent |
| Restoration | Multi-unit | Multi-unit | Equivalent |
| Implant-Abutment
Platform Diameter
(mm) | 3.5-7.0 | 3.25 - 5 | Addition of abutments
compatible with Ø7.0mm
TS and ET System
implants do not raise
different questions of
safety and effectiveness.
Mechanical testing
demonstrates equivalency. |
| Gingival Height (mm) | 0.6-5.5 | 0.6-5.5 | Equivalent |
| Abutment Angulation
(degrees) | Straight, 17°, 30° | Straight, 17°, 30° | Equivalent |
| Abutment & Abutment
Screw Materials | Ti6Al4V, medical grade 5,
conforming to ASTM F136 | Ti6Al4V, medical grade 5,
conforming to ASTM F136 | Equivalent |
| Comparison | Subject
Multi-unit Abutments | K191123
Multi-unit Abutments | Equivalence |
| Sterilization | Supplied sterile
Gamma irradiation | Supplied sterile
Gamma irradiation | Equivalent |
| Usage | Single-patient, single-use | Single-patient, single-use | Equivalent |
| Packaging | Medical grade polyethylene blister
with a sealing lid | Medical grade polyethylene
blister with a sealing lid | Equivalent |
24
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.
25
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.