(84 days)
Medentika Custom Abutments AS (Angulated Screw Channel) 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 Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.
Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
The Custom Abutments (previously named MedentiCAD and PreFace abutments) can be used in combination with cemented prosthetics, e.g., crowns and superstructures, to reconstruct the function and esthetics of lost teeth. The Custom Abutment is a one-piece abutment, which is a customized abutment that is digitally designed by the customer with Straumann® CARES® Visual and can be only milled and ordered from the Straumann validated milling center. The abutments have an implant-specific connection interface for the respective compatible implant. The previously cleared Custom Abutments feature a straight screw channel for the abutment screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments AS (Angulated Screw Channel) to the Medentika Custom Abutment Portfolio. The subject Medentika Custom Abutments AS can be designed and manufactured with an angled screw channel (as opposed to the predicate straight screw-channel), so that the screw-exit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angulated to allow screwdriver access at an angle up to 25°.
Each of the abutment to implant connection geometries (in terms of Series and implant diameter) currently exists for the existing marketed Medentika Custom Abutments (with straight screw channel). No new compatible implant is added, in terms of series, implant diameter, and implant platform diameter within this submission.
N/A
FDA 510(k) Clearance Letter - Custom Abutment AS
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
MEDENTiKA GmbH
℅ Jennifer Jackson
Sr Dir, Regulatory & Quality NAM
Straumann USA, LLC
60 Minuteman Road
Andover, Massachusetts 01810
Re: K253341
Trade/Device Name: Custom Abutment AS
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA
Dated: September 30, 2025
Received: September 30, 2025
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.
December 23, 2025
Page 2
December 23, 2025
MEDENTiKA GmbH
℅ Jennifer Jackson
Sr Dir, Regulatory & Quality NAM
Straumann USA, LLC
60 Minuteman Road
Andover, Massachusetts 01810
Re: K253341
Trade/Device Name: Custom Abutment AS
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA
Dated: September 30, 2025
Received: September 30, 2025
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.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 3
K253341 - Jennifer Jackson Page 2
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 4
K253341 - Jennifer Jackson Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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
Page 5
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): K253341
Device Name: Custom Abutments AS
Indications for Use (Describe)
Medentika Custom Abutments AS (Angulated Screw Channel) 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 Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.
Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 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 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 | 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 |
| F-Series | Nobel Biocare | NobelActive® CC | 3.0, 3.5, 4.3, 5.0, 5.5 | 3.0, 3.5, 4.3/5.0, 5.5 |
| H-Series | ZimVie | Biomet 3i Certain® Internal Connection | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| I-Series | ZimVie | Biomet 3i External Hex | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| K-Series | Nobel Biocare | Branemark System®, NobelSpeedy®, Groovy® | 3.3, 3.75,4.0,5.0 | 3.5, 4.1, 5.1 |
| L-Series | Straumann | Bone Level | 2.9, 3.3, 4.1, 4.8 | SC, NC, RC |
| N-Series | Straumann | Tissue Level | 3.3, 4.1, 4.8 | NNC, RN, WN |
| 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 |
| R-Series | ZimVie | Tapered Screw-Vent® | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5,5.7 |
| S-Series | Dentsply Implants | ASTRA TECH OsseoSpeed® TX | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5/ 4.0, 4.5/ 5.0 |
| T-Series | Dentsply Implants | XiVE® S | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |
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.
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.
Page 6
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): K253341
Device Name: Custom Abutments AS
Indications for Use (Describe)
Medentika Custom Abutments AS (Angulated Screw Channel) 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 Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.
Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 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 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 | 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 |
| F-Series | Nobel Biocare | NobelActive® CC | 3.0, 3.5, 4.3, 5.0, 5.5 | 3.0, 3.5, 4.3/5.0, 5.5 |
| H-Series | ZimVie | Biomet 3i Certain® Internal Connection | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| I-Series | ZimVie | Biomet 3i External Hex | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| K-Series | Nobel Biocare | Branemark System®, NobelSpeedy®, Groovy® | 3.3, 3.75,4.0,5.0 | 3.5, 4.1, 5.1 |
| L-Series | Straumann | Bone Level | 2.9, 3.3, 4.1, 4.8 | SC, NC, RC |
| N-Series | Straumann | Tissue Level | 3.3, 4.1, 4.8 | NNC, RN, WN |
| 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 |
| R-Series | ZimVie | Tapered Screw-Vent® | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5,5.7 |
| S-Series | Dentsply Implants | ASTRA TECH OsseoSpeed® TX | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5/ 4.0, 4.5/ 5.0 |
| T-Series | Dentsply Implants | XiVE® S | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |
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.
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.
Page 7
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) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 8
K253341 Traditional 510(k) Submission
Custom Abutments AS
510(k) Summary
Medentika GmbH 1
510(k) Summary
Submitter's Contact Information
Submitter: Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052
On behalf of:
MEDENTiKA GmbH,
Hammweg 8-10,
76549 Hügelsheim, Germany
Contact Person: Jennifer M. Jackson, MS
Director of Regulatory Affairs
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023
Prepared By: Laura Bleyendaal
Sr. Regulatory Affairs Specialist
Date of Submission: December 17, 2025
Name of the Device
Trade Names: Custom Abutments AS
Common Name: Endosseous dental implant abutment
Classification Name: Endosseous dental implant abutment
Regulation Number: 21 CFR 872.3630
Device Classification: II
Product Code(s): NHA
Classification Panel: Dental
Predicate Device(s)
Primary Predicate:
Page 9
K253341 Traditional 510(k) Submission
Custom Abutments AS
510(k) Summary
Medentika GmbH 2
- K223113 – Medentika CAD/CAM Abutments
- Custom Abutments Series E, EV, F, and OT with a straight screw channel
Reference Devices:
-
K150203- Medentika CAD/CAM Abutments
- Custom Abutments Series E, F, H, I, K, L, N, R, S and T with a straight screw channel
-
K242542- Medentika CAD/CAM Abutments
- Custom Abutment Series L (SC) with a straight screw channel
-
K242542- Medentika CAD/CAM Abutments
- TiBases CAD/CAM ASC Flex to support angulated screw channel feature and Abutment screws
-
K223113- Medentika CAD/CAM Abutments
- TiBases CAD/CAM ASC Flex to support angulated screw channel feature and Abutment screws
-
K180564 – Medentika MRI Compatibility
- To support MRI compatibility
Device Description
Medentika GmbH Custom Abutments
The Custom Abutments (previously named MedentiCAD and PreFace abutments) can be used in combination with cemented prosthetics, e.g., crowns and superstructures, to reconstruct the function and esthetics of lost teeth. The Custom Abutment is a one-piece abutment, which is a customized abutment that is digitally designed by the customer with Straumann® CARES® Visual and can be only milled and ordered from the Straumann validated milling center. The abutments have an implant-specific connection interface for the respective compatible implant. The previously cleared Custom Abutments feature a straight screw channel for the abutment screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments AS (Angulated Screw Channel) to the Medentika Custom Abutment Portfolio. The subject Medentika
Page 10
K253341 Traditional 510(k) Submission
Custom Abutments AS
510(k) Summary
Medentika GmbH 3
Custom Abutments AS can be designed and manufactured with an angled screw channel (as opposed to the predicate straight screw-channel), so that the screw-exit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angulated to allow screwdriver access at an angle up to 25°.
Each of the abutment to implant connection geometries (in terms of Series and implant diameter) currently exists for the existing marketed Medentika Custom Abutments (with straight screw channel). No new compatible implant is added, in terms of series, implant diameter, and implant platform diameter within this submission.
Indications for Use
Medentika Custom Abutments AS (Angulated Screw Channel) 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 Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.
Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 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 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 | 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 |
Page 11
K253341 Traditional 510(k) Submission
Custom Abutments AS
510(k) Summary
Medentika GmbH 4
| Medentika Series of the medical device | Manufacturer of the implant system | Compatible implant system | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|---|---|
| F-Series | Nobel Biocare | NobelActive® CC | 3.0, 3.5, 4.3, 5.0, 5.5 | 3.0, 3.5, 4.3/5.0, 5.5 |
| H-Series | ZimVie | Biomet 3i Certain® Internal Connection | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| I-Series | ZimVie | Biomet 3i External Hex | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| K-Series | Nobel Biocare | Branemark System®, NobelSpeedy®, Groovy® | 3.3, 3.75,4.0,5.0 | 3.5, 4.1, 5.1 |
| L-Series | Straumann | Bone Level | 2.9, 3.3, 4.1, 4.8 | SC, NC, RC |
| N-Series | Straumann | Tissue Level | 3.3, 4.1, 4.8 | NNC, RN, WN |
| 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 |
| R-Series | ZimVie | Tapered Screw-Vent® | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5,5.7 |
| S-Series | Dentsply Implants | ASTRA TECH OsseoSpeed® TX | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5/ 4.0, 4.5/ 5.0 |
| T-Series | Dentsply Implants | XiVE® S | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table:
Page 12
K253341 Traditional 510(k) Submission
Custom Abutments AS
510(k) Summary
Medentika GmbH 5
Table.1 Substantial Equivalence – Indications for Use Statement.
Indications for Use Statement
Subject Device
Medentika Custom Abutments AS
Medentika GmbH
Medentika Custom Abutments AS (Angulated Screw Channel) 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 Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.
Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 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 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 | 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 |
| F-Series | Nobel Biocare | NobelActive® CC | 3.0, 3.5, 4.3, 5.0, 5.5 | 3.0, 3.5, 4.3/5.0, 5.5 |
| H-Series | ZimVie | Biomet 3i Certain® Internal Connection | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| I-Series | ZimVie | Biomet 3i External Hex | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| K-Series | Nobel Biocare | Branemark System®, NobelSpeedy®, Groovy® | 3.3, 3.75,4.0,5.0 | 3.5, 4.1, 5.1 |
| L-Series | Straumann | Bone Level | 2.9, 3.3, 4.1, 4.8 | SC, NC, RC |
| N-Series | Straumann | Tissue Level | 3.3, 4.1, 4.8 | NNC, RN, WN |
| 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 |
| R-Series | ZimVie | Tapered Screw-Vent® | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5,5.7 |
| S-Series | Dentsply Implants | ASTRA TECH OsseoSpeed® TX | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5/ 4.0, 4.5/ 5.0 |
| T-Series | Dentsply Implants | XiVE® S | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |
Page 13
K253341 Traditional 510(k) Submission
Custom Abutments AS
510(k) Summary
Medentika GmbH 6
Indications for Use Statement
Primary Predicate Device
K223113
Medentika CAD/CAM Abutments
(Portions relevant to current submission)
Medentika GmbH
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 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 |
| 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 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 |
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Custom Abutments AS
510(k) Summary
Medentika GmbH 7
Indications for Use Statement
Reference Device
K242542
Medentika CAD/CAM Abutments
Medentika GmbH
PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, and Titanium base ASC Flex 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. Abutment-level prosthetic components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are intended for use as a support for multi-unit screw-retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
All digitally designed abutments for use with PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, Titanium base ASC Flex, Multi-unit Titanium Base, Multi-unit Titanium Cap, and MedentiBASE Titanium Base are intended to be sent to an FDA-registered Medentika validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: Scans from desktop and intra oral scanners, CAD and CAM software and milling machine with associated accessories.
Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Implant System Compatibility Series:
| 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 | 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 |
| F-Series | Nobel Biocare | NobelActive® | 3.0, 3.5, 4.3, 5.0, 5.5 | 3.0, NP 3.5, RP 4.3/5.0,WP 5.5 |
| GM-Series | Neodent | Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| H-Series | ZimVie | Biomet 3i Certain® Internal Connection | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| I-Series | ZimVie | Biomet 3i External Hex | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| K-Series | Nobel Biocare | Branemark System®, NobelSpeedy®, Groovy® | 3.3, 3.75,4.0, 5.0 | 3.5, 4.1, 5.1 |
| L-Series | Straumann | Bone Level | 2.9, 3.3, 4.1, 4.8 | SC, NC, RC |
| LX-Series | Straumann | BLX / BLC | 3.3, 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |
| MG-Series | Megagen | AnyRidge | 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 | 3.5 |
| N-Series | Straumann | Tissue Level | 3.3, 4.1, 4.8 | NNC, RN, WN |
| 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 |
| R-Series | ZimVie | Tapered Screw-Vent® | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5,5.7 |
| S-Series | Dentsply Implants | ASTRA TECH OsseoSpeed® TX | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5/ 4.0, 4.5/ 5.0 |
| T-Series | Dentsply Implants | XiVE® S | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |
| Y-Series | Dentsply Implants | Ankylos C/X | 3.5. 4.5, 5.5, 6.5 | 2.53 |
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Medentika GmbH 8
Table 2. Comparative Summary of Technological Characteristics.
| Comparison | Medentika Custom Abutments AS | K223113 Medentika Preface CAD/CAM abutments | K242542 Medentika CAD/CAM Abutments (PreFace, TI-Forms) | K150203 Medentika Preface Abutments | K223113 Medentika CAD/CAM TiBases ASC Flex | K242542 Medentika CAD/CAM Abutments TiBases ASC Flex | Equivalence |
|---|---|---|---|---|---|---|---|
| FDA product code | NHA | NHA | NHA, PNP | NHA | NHA | NHA, PNP | Identical |
| Series | E, EV, F, H, I, K, L, N, OT, R, S, T | E, EV, F, OT | E, EV, F,GM, H, I, K, L, LX, MG, N, OT, R, S, T, Y | E, F, H, I, K, L, N, R, S, T | Titanium base EV, S, F, OT | Titanium base E, EV, F, H, I, K, L, N, R, S, T | Equivalent. No new series is added. No new compatible implant system is introduced, in terms of series, implant diameter and platform diameter with this submission. |
| Abutment Designs | Titanium blank Ø13 with pre-manufactured implant-interface Customized at validated milling center | Titanium blank Ø11.5 and 16mm with pre-manufactured implant-interface Customized at validated milling center | Titanium Blank, Ø 11.5 and 11.8 mm with pre-manufactured implant-interface Customized at validated milling center or to be manufactured according to the digital dentistry workflow | Titanium blank Ø11.5 and 16mm with pre-manufactured implant-interface Customized at validated milling center | Titanium base Angled Screw Channel (ASC) Flex | Titanium base Angled Screw Channel (ASC) Flex | Equivalent |
| Prosthesis Attachment | Cement retained | Cement retained | Cement retained | Cement retained | Cement retained | Cement retained | Equivalent |
| Compatible Implant Body Diameter (mm) | 2.9 - 7.0 | 3.0-7.0 | 2.9 – 8.0 | 3.0-6.5 | 3.0-7.0 | 2.9 – 8.0 | 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 | 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 | 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 | Identical |
| Usage- All components | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Identical |
| Design Limits | |||||||
| Minimum wall thickness to screw channel (mm) | 0.5 | 0.4 | 0.4 | 0.4 | Not applicable; Titanium base | Not applicable; Titanium base | Equivalent |
| Minimum gingival height in stock component (mm) | 0.1 (for N series abutments for use with tissue level implant systems, gingival height is given by the implant design) | 0.1-0.25 | Not supplied in 510(k) summary | 0.00-0.23 | Not applicable; Titanium base | Not applicable; Titanium base | Equivalent Labeling includes specific warnings for gingival heights less than 0.5mm |
| Maximum gingival height (mm) | 8.3 | 5 | 5 | 6 | Not applicable; Titanium base | Not applicable; Titanium base | An engineering rationale supports the maximum gingival height. |
| Max angulation of abutment body to implant axis (degrees) | 30° | 30° | 30° | 30° | 30° | 30° | Equivalent |
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Medentika GmbH 9
| Comparison | Medentika Custom Abutments AS | K223113 Medentika Preface CAD/CAM abutments | K242542 Medentika CAD/CAM Abutments (PreFace, TI-Forms) | K150203 Medentika Preface Abutments | K223113 Medentika CAD/CAM TiBases ASC Flex | K242542 Medentika CAD/CAM Abutments TiBases ASC Flex | Equivalence |
|---|---|---|---|---|---|---|---|
| Minimum abutment post height (mm) (height above the abutment collar/gingival height) (for single unit restorations) | 4.0 | 4.0 | 4.0 | 4.0 | Not applicable; Titanium base | Not applicable; Titanium base | Equivalent |
| Max screw channel angulation | up to 25° from the implant axis | Straight | Straight | Straight | Titanium base ASC Flex is a titanium base abutment that permits an angled screw channel ("ASC") and allows for modification of the chimney height. It was developed for either a straight screw channel or to allow for moving the screw channel in an oral direction for esthetic purposes. | Titanium base ASC Flex is a titanium base abutment that permits an angled screw channel ("ASC") and allows for modification of the chimney height. It was developed for either a straight screw channel or to allow for moving the screw channel in an oral direction for esthetic purposes. | Equivalent |
| Design workflow | Computer aided design (CAD) | Computer aided design (CAD) | Computer aided design (CAD) | Computer aided design (CAD) | N/A; Titanium base | N/A; Titanium base | Equivalent |
| Manufacturing workflow | Milled at Straumann validated milling center | Milled at Straumann CARES validated milling center | Milled at an FDA registered Medentika validated milling center or at point-of-care | Milled at Straumann CARES validated milling center | N/A; Titanium base | N/A; Titanium base | Equivalent |
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Custom Abutments AS
510(k) Summary
Medentika GmbH 10
Materials
Medentika Custom Abutments AS
The Custom abutment AS (Angulated Screw Channel) and abutment screws are manufactured from titanium alloy conforming to ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Performance data
Nonclinical testing data submitted, referenced or relied upon to demonstrate substantial equivalence in this 510(k) includes:
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Dynamic fatigue testing according to Root-form endosseous dental implants and endosseous dental abutments- class II special controls guidance document for industry and FDA staff and Guidance for industry and ISO 14801: 2016 Dentistry — implants — dynamic loading test for endosseous dental implant.
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Referenced from K223113, K242542, K150203 and K170838 (Medentika GmbH) was dimensional analysis and reverse engineering of the implant-to-abutment connection platform, 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.
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Referenced from K223113 and K242542 (Medentika GmbH) Medentika TiBases CAD/CAM ASC Flex was compared to support angulated screw channel feature.
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Referenced from K223113 (Medentika GmbH) was steam sterilization validations 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.
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Referenced from K180564 (Medentika GmbH) was MR testing in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a and ASTM F2119-13.
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Referenced from K223113 (Medentika GmbH) was biocompatibility comparisons in accordance with ISO 10993-1, Biological evaluation report Custom Abutments Titanium,
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510(k) Summary
Medentika GmbH 11
which covers biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Conclusion
The data included in this submission demonstrates 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.)