(178 days)
No
The summary describes a mechanical dental abutment system and CAD/CAM design process, with no mention of AI or ML technologies.
No
This device is a dental abutment, which is a prosthetic component used to support dental prostheses on implants, not a device intended for therapy or treatment of a disease or condition itself.
No
This device, the Medentika TiBase CAD/CAM Abutment, is described as a component (titanium base) for dental prostheses used to support single or multiple tooth prostheses. Its intended use and device description focus on its function as a supportive element within a restorative dental procedure, not on identifying, diagnosing, or predicting a disease or condition.
No
The device description explicitly states that the Medentika TiBases are titanium bases, which are hardware components. The submission also details mechanical testing and sterilization validation, which are typical for physical medical devices. While software is mentioned for the design process, the core device is a physical abutment.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Medentika TiBase CAD/CAM Abutments are physical components used in dental prosthetics. They are implanted into the jawbone and serve as a support for artificial teeth.
- Intended Use: The intended use clearly states they are for supporting dental prostheses in the mouth of a patient. This is a therapeutic and restorative function, not a diagnostic one involving in vitro analysis of bodily specimens.
The provided information describes a medical device used in a surgical and restorative procedure, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / 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.
Product codes
NHA
Device Description
The Medentika TiBases are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The TiBases are provided in several models and dimensions, according to the compatible implant systems declared in the Indications for Use statement.
The design of the CAD/CAM restorations is to be carried out through the Straumann CARES Visual Plug-In for Dental Wings CAD System. The patient-specific restorations must be milled by a Straumann milling center.
This submission includes:
- New TiBases with a shorter prosthetic height (3.5mm), as follows: .
- o E-Series
- o F-Series
- H-Series o
- o I-Series
- o K-Series
- L-Series o
- N-Series o
- R-Series o
- S-Series O
- o T-Series
- . A new line of titanium bases (EV-Series) compatible with Dentsply® Implants/ASTRA TECH OsseoSpeed® EV implants
- The zirconia raw material (zerion®, K061804) for the CAD/CAM restorations for . use on the new shorter TiBases which had been previously cleared for use with the predicate Medentika TiBases (K150203)
- An additional restoration material (IPS e.max CAD, K051705) for the CAD/CAM ● restorations for use on the previously cleared TiBases (K150203) and the new shorter TiBases
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)
Biocompatibility Testing: Conducted in accordance with ISO 10993-1:2009 and FDA Guidance. The subject devices have identical biocompatibility properties as the primary predicate devices due to identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods. No additional testing was required.
Sterilization Validation: Medentika titanium bases are provided non-sterile. Sterilization cycle validated to a sterility assurance level (SAL) of 10^-6 by the overkill method, according to ISO 17665-1 and ISO 17665-2.
Mechanical Testing: Mechanical strength demonstrated through fatigue testing performed according to ISO 14801 and the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.
Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments, and OEM abutment screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K142890, K051705, K061804, K162890, K130436
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2017
Medentika GmbH % Jennifer M. Jackson, MS Director. Regulatory Affairs & Ouality Straumann USA, LLC 60-100 Minuteman Road Andover, Massachusetts 01810
Re: K170838
Trade/Device Name: Medentika CAD/CAM TiBases Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 15, 2017 Received: August 16, 2017
Dear Jennifer M. Jackson, MS:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170838
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.
| Implant System Compatibility | Series | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|---|
| Nobel Biocare Replace Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 |
| Dentsply®Implants/ASTRA TECH | |||
| OsseoSpeed® EV | EV | 3.6, 4.2, 4.8, 5.4 | 3.6, 4.2, 4.8, 5.4 |
| Nobel Biocare Nobel Active | 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 |
| Biomet 3i Osseotite | - | 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 / 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 |
| Astra Tech OsseoSpeed | ട | 3.5, 4.0, 4.5, 5.0 | 3.5, 4.0, 4.5, 5.0 |
| 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.
Type of Use (Select one or both, as applicable)
|X 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."
3
Traditional 510(k) Submission
Medentika CAD/CAM TiBases
510(k) Summary
K170838
510(k) Summary
Submitter
Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
on behalf of:
Medentika GmbH
Hammweg 8-10
76549 Hügelsheim, Germany
Contact Person:
Jennifer M. Jackson, MS
Director, Regulatory Affairs & Quality, Straumann USA, LLC
Telephone: (978) 747-2509
Fax: (978) 747-0023
Prepared By and Alternate Contact:
Ana Carolina Martins Vianna
Regulatory Affairs & Compliance Manager, Institut Straumann AG
Date Prepared: 15 Sep 2017
Device
Trade Name: Medentika CAD/CAM TiBases Common Name: Endosseous dental implant abutment Classification Name: Endosseous dental implant abutment (21 CFR 872.3630) Regulatory Class: ll Product Code: NHA
4
Traditional 510(k) Submission Medentika CAD/CAM TiBases 510(k) Summary
Predicate Device
Primary Predicate:
K150203 – Medentika CAD/CAM Abutments, Medentika GmbH
Reference Predicates:
K142890 – Straumann® CARES® Variobase™ Abutments, Institut Straumann AG
K051705 - IPS e.max® CAD / IPS e.max ZIRCAD, Ivoclar Vivadent, Inc.
K061804 – zerion®, etkon International GmbH
- K162890 Straumann BLT 02.9mm SC. SLA or SLActive, RXD. Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
- K130436 Ivoclar Vivadent Multilink Hybrid Abutment Cement
Device Description
The Medentika TiBases are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The TiBases are provided in several models and dimensions, according to the compatible implant systems declared in the Indications for Use statement.
The design of the CAD/CAM restorations is to be carried out through the Straumann CARES Visual Plug-In for Dental Wings CAD System. The patient-specific restorations must be milled by a Straumann milling center.
This submission includes:
- New TiBases with a shorter prosthetic height (3.5mm), as follows: .
- o E-Series
- o F-Series
- H-Series o
- o I-Series
- o K-Series
5
Traditional 510(k) Submission
Medentika CAD/CAM TiBases
510(k) Summary
- L-Series o
- N-Series o
- R-Series o
- S-Series O
- o T-Series
- . A new line of titanium bases (EV-Series) compatible with Dentsply® Implants/ASTRA TECH OsseoSpeed® EV implants
- The zirconia raw material (zerion®, K061804) for the CAD/CAM restorations for . use on the new shorter TiBases which had been previously cleared for use with the predicate Medentika TiBases (K150203)
- An additional restoration material (IPS e.max CAD, K051705) for the CAD/CAM ● restorations for use on the previously cleared TiBases (K150203) and the new shorter TiBases
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.
| Implant System Compatibility | Series | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|---|
| Nobel Biocare Replace Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 |
| Dentsply® Implants/ASTRA | |||
| 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) |
| Biomet 3i Osseotite Certain | 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 |
| 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 / 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 |
| Astra Tech OsseoSpeed | S | 3.5, 4.0, 4.5, 5.0 | 3.5, 4.0, 4.5, 5.0 |
| 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 |
6
Traditional 510(k) Submission Medentika CAD/CAM TiBases 510(k) Summary
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.
Technological Characteristics
The subject and the primary predicate devices are two-piece abutments used as a base when fabricating a CAD/CAM restoration. The subject and primary predicate devices are based on the following same technological elements:
- . design
- function
- sterilization .
- packaging ●
The following technological differences exist between the subject and primary predicate devices:
- prosthetic height (also referred to as chimney height) .
- a new line of titanium bases (EV-Series) .
- an additional previously cleared restoration material, IPS e.max CAD (K051705), . is being indicated for the coping/crown
Table 1 provides a comparison of the features of the subject devices to the predicate devices. The assessment of the differences is also included.
7
Traditional 510(k) Submission
Medentika CAD/CAM TiBases
510(k) Summary
| Indications for Use | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE DEVICES | EQUIVALENCE DISCUSSION | | SUBJECT DEVICE
Medentika CAD/CAM
Titanium Bases | PRIMARY PREDICATE
Medentika CAD/CAM Abutments
(K150203) | REFERENCE DEVICES
Straumann CARES Variobase
(K142890) | EQUIVALENCE DISCUSSION |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | Medentika CAD/CAM Titanium Bases | Medentika CAD/CAM Abutments (K150203) | Straumann CARES Variobase (K142890) | Equivalent | Prosthetic Height(s) | 3.5 mm and 5.5 mm | 4.0 mm and 5.5mm | 3.5 mm | Equivalent |
| | Medentika CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | Medentika CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. | The difference in the Indications For Use statements is related to addition of the subject devices. | | | | | The prosthetic height of the subject
devices is the same as cleared for
the predicate and reference devices. |
| | Abutments are compatible with the following implant systems:
• E-Series: Nobel Biocare Replace Select 3.5, 4.3, 5.0, 6.0
• EV-Series: Dentsply Implants / ASTRA TECH OsseoSpeed EV 3.6, 4.2, 4.8, 5.4
• F-Series: Nobel Biocare NobelActive 3.5, 4.3, 5.0
• H-Series: Biomet 3i Osseotite Certain 3.25, 4.0, 5.0
• I-Series: Biomet 3i Osseotite 3.25, 3.75, 4.0, 5.0
• K-Series: Nobel Biocare Brånemark 3.3, 3.75, 4.0, 5.0
• L-Series: Straumann Bone Level 3.3, 4.1, 4.8
• N-Series: Straumann Standard 3.3, 4.1, 4.8
• R-Series: Zimmer Tapered Screw-Vent 3.3, 3.7, 4.1, 4.7, 6.0
• S-Series: Astra Tech OsseoSpeed 3.5/4.0, 4.5/5.0
• T-Series: Dentsply Friadent Frialit/XiVE 3.4, 3.8, 4.5, 5.5
• Y-Series: Dentsply Friadent Ankylos 3.5, 4.5, 5.5, 7.0
• Medentika TiBase is intended for use with the Straumann® CARES® System. | Abutments are compatible with the following implant systems:
• E-Series: Nobel Biocare Replace™ Select 3.5, 4.3, 5.0, 6.0
• F-Series: Nobel Biocare NobelActive™ 3.5, 4.3, 5.0
• H-Series: Biomet 3i Osseotite Certain 3.25, 4.0, 5.0
• I-Series: Biomet 3i Osseotite 3.25, 3.75, 4.0, 5.0
• K-Series: Nobel Biocare Brånemark 3.3, 3.75, 4.0, 5.0
• L-Series: Straumann Bone Level 3.3, 4.1, 4.8
• N-Series: Straumann Standard 3.3, 4.1, 4.8
• R-Series: Zimmer Tapered Screw-Vent 3.3, 3.7, 4.1, 4.7, 6.0
• S-Series: Astra Tech OsseoSpeed 3.5/4.0, 4.5/5.0
• T-Series: Dentsply Friadent Frialit/XiVE 3.4, 3.8, 4.5, 5.5
• Y-Series: Dentsply Friadent Ankylos 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 for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. | The basic indication of providing support for CAD/CAM prostheses is identical. All devices are CAD/CAM abutment designs to be used as a base when fabricating a patient-specific restoration. | Material of abutment | Titanium-aluminum-
vanadium alloy Ti-6Al-4V | Titanium-aluminum-
vanadium alloy Ti-6Al-4V | Titanium-Aluminum-Niobium alloy
(Ti-6Al-7Nb) | Equivalent |
| | All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center. | | | | | | | | All devices are made of titanium
alloy. The subject devices are made
of the same titanium alloy as the
primary predicate device. |
| | SUBJECT DEVICE
Medentika CAD/CAM
Titanium Bases
Implant / Abutment
Diameter(s) | PRIMARY PREDICATE
Medentika CAD/CAM Abutments
(K150203) | REFERENCE DEVICES
Straumann CARES Variobase
(K142890) | EQUIVALENCE DISCUSSION | Material of restoration | Zirconia
IPS e.max CAD | Zirconia | Acrylics (temporary)
Zirconia (permanent)
IPS e.max CAD (permanent)
CoCr (permanent) | Equivalent |
| | E-Series: Nobel Biocare Replace
Select 3.5, 4.3, 5.0, 6.0 EV-Series: Dentsply Implants /
ASTRA TECH OsseoSpeed EV
3.6, 4.2, 4.8, 5.4 F-Series: Nobel Biocare
NobelActive 3.5, 4.3, 5.0 H-Series: Biomet 3i Osseotite
Certain 3.25, 4.0, 5.0 I-Series: Biomet 3i Osseotite
3.25, 3.75, 4.0, 5.0 K-Series: Nobel Biocare
Brånemark 3.3, 3.75, 4.0, 5.0 L-Series: Straumann Bone Level
3.3, 4.1, 4.8 N-Series: Straumann Standard
3.3, 4.1, 4.8 R-Series: Zimmer Tapered
Screw-Vent 3.3, 3.7, 4.1, 4.7, 6.0 S-Series: Astra Tech
OsseoSpeed 3.5/4.0, 4.5/5.0 T-Series: Dentsply Friadent
Frialit/XiVE 3.4, 3.8, 4.5, 5.5 Y-Series: Dentsply Friadent
Ankylos 3.5, 4.5, 5.5, 7.0 | E-Series: Nobel Biocare Replace
Select 3.5, 4.3, 5.0, 6.0 F-Series: Nobel Biocare
NobelActive 3.5, 4.3, 5.0 H-Series: Biomet 3i Osseotite
Certain 3.25, 4.0, 5.0 I-Series: Biomet 3i Osseotite
3.25, 3.75, 4.0, 5.0 K-Series: Nobel Biocare
Brånemark 3.3, 3.75, 4.0, 5.0 L-Series: Straumann Bone Level
3.3, 4.1, 4.8 N-Series: Straumann Standard
3.3, 4.1, 4.8 R-Series: Zimmer Tapered
Screw-Vent 3.3, 3.7, 4.1, 4.7, 6.0 S-Series: Astra Tech
OsseoSpeed 3.5/4.0, 4.5/5.0 T-Series: Dentsply Friadent
Frialit/XiVE 3.4, 3.8, 4.5, 5.5 Y-Series: Dentsply Friadent
Ankylos® 3.5, 4.5, 5.5, 7.0 | 3.3, 4.1 and 4.8 mm | Equivalent
The subject device diameters are
within the range of diameters for the
primary predicate devices, so that no
new concern is raised. | | | | | The materials indicated for the
subject devices are within the range
of materials cleared for use with the
predicate devices. |
| Implant-to-Abutment
Connection /
Compatible implant
systems | Nobel Biocare Replace™ Select Dentsply® Implants/ASTRA TECH
OsseoSpeed® EV EV-Series Nobel Biocare NobelActive™ Biomet 3i Osseotite® Certain® Biomet 3i Osseotite® Nobel Biocare Brånemark Straumann Bone Level Straumann Standard Zimmer Tapered Screw-Vent® Astra Tech OsseoSpeed™ Dentsply Friadent® Frialit/XiVE® Dentsply Friadent® Ankylos® | Nobel Biocare Replace™ Select Nobel Biocare NobelActive™ Biomet 3i Osseotite® Certain® Biomet 3i Osseotite® Nobel Biocare Brånemark Straumann Bone Level Straumann Standard Zimmer Tapered Screw-Vent® Astra
Tech OsseoSpeed™ Dentsply Friadent® Frialit/XiVE® Dentsply Friadent® Ankylos® | NNC (Narrow Neck CrossFit),
RN (Regular Neck),
WN (Wide Neck),
NC (Narrow CrossFit),
RC (Regular CrossFit) | Equivalent
Most of the connection styles of the
subject devices are within the range
of connections of the primary
predicate devices. The new
connection has been assessed
through fatigue testing. | Cement used in device
performance testing
Cement to fix patient-
specific coping to
TiBase according to
IFU | Multilink Hybrid Abutment Cement,
cleared by FDA under K130436
Multilink Hybrid Abutment Cement,
cleared by FDA under K130436 | Multilink Hybrid Abutment Cement,
cleared by FDA under K130436
Multilink Hybrid Abutment Cement,
cleared by FDA under K130436 | | Identical |
| Restoration
Angulation(s) | Up to 30° | Up to 30° | Up to 30° | Identical | | | | | |
| CAD/CAM System
Sterility | Straumann CARES System
Delivered non-sterile; to be sterilized
by user | Straumann CARES System
Delivered non-sterile; to be sterilized
by user | Straumann CARES System
Delivered non-sterile; to be sterilized
by user | Identical | | | | | |
| Sterilization by end
user | Moist heat sterilization | Moist heat sterilization | Moist heat sterilization | Identical | | | | | |
8
Traditional 510(k) Submission
Medentika CAD/CAM TiBases
510(k) Summary
9
Traditional 510(k) Submission
Medentika CAD/CAM TiBases
510(k) Summary
able 1 – Comparison between the subject and predicate device
10
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the subject devices was conducted in accordance with ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016".
The subject devices have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the primary predicate devices. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.
Sterilization Validation
Medentika titanium bases are provided non-sterile. Prior to use, sterilization is recommended. This cycle has been validated to a sterility assurance level (SAL) of 10 by the overkill method, according to ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO 17665-2 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1.
Mechanical Testing
The mechanical strength of the system is demonstrated through fatigue testing performed according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and the FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.
11
Traditional 510(k) Submission Medentika CAD/CAM TiBases 510(k) Summary
Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments, and OEM abutment screws.
Conclusion
Based upon the assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.