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.

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.

AI/ML Overview

This document is a 510(k) submission for the Medentika CAD/CAM TiBases, which are dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a de novo approval requiring extensive clinical studies with acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes for AI/ML devices. Therefore, much of the requested information regarding AI/ML specific studies (MRMC, standalone performance, ground truth establishment for training/test sets, expert qualifications, adjudication methods) is not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (dental implant abutments), the "acceptance criteria" are related to mechanical performance and biocompatibility, demonstrating that the new devices are as safe and effective as the predicate devices. The performance data presented are primarily comparative to predicate devices rather than against specific numerical thresholds in a table.

Acceptance Criteria Category	Device Performance (as described in the document)
Biocompatibility	Evaluated in accordance with ISO 10993-1:2009 and FDA Guidance. New issues of biocompatibility not raised as the subject devices have identical body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to primary predicate devices.
Sterilization Validation	Medentika titanium bases are non-sterile; user sterilization is recommended. The recommended cycle has been validated to a sterility assurance level (SAL) of 10⁻⁶ by the overkill method, according to ISO 17665-1 and ISO 17665-2.
Mechanical Performance	Demonstrated through fatigue testing performed according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) and FDA guidance for Class II Special Controls. The tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices.
Dimensional Analysis	Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments, and OEM abutment screws (details on results not explicitly given, but implies successful comparison).

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of an AI/ML device evaluating data. For mechanical testing, specific sample sizes are not provided in this summary, but would typically be defined by the relevant ISO standards (e.g., ISO 14801). The "data provenance" would be from laboratory testing performed on the physical devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable for this type of device submission. Dental implant abutments do not use expert-established ground truth in the same way an AI diagnostic algorithm would.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this is not an AI/ML device, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a physical medical device (dental implant abutment), not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility and sterilization, the "ground truth" is established by adherence to international standards (ISO 10993-1, ISO 17665-1/2) and successful completion of the tests defined within those standards. For mechanical testing, the "ground truth" is the established performance of the predicate device under specified fatigue test conditions as per ISO 14801.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

{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)

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 TECHOsseoSpeed® 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

ana.vianna@straumann.com

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

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

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/ASTRATECH 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 DEVICEMedentika CAD/CAMTitanium Bases	PRIMARY PREDICATEMedentika CAD/CAM Abutments(K150203)	REFERENCE DEVICESStraumann 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 subjectdevices is the same as cleared forthe 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, 7.0Medentika 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 titaniumalloy. The subject devices are madeof the same titanium alloy as theprimary predicate device.
	SUBJECT DEVICEMedentika CAD/CAMTitanium BasesImplant / AbutmentDiameter(s)	PRIMARY PREDICATEMedentika CAD/CAM Abutments(K150203)	REFERENCE DEVICESStraumann CARES Variobase(K142890)	EQUIVALENCE DISCUSSION	Material of restoration	ZirconiaIPS e.max CAD	Zirconia	Acrylics (temporary)Zirconia (permanent)IPS e.max CAD (permanent)CoCr (permanent)	Equivalent
	E-Series: Nobel Biocare ReplaceSelect 3.5, 4.3, 5.0, 6.0 EV-Series: Dentsply Implants /ASTRA TECH OsseoSpeed EV3.6, 4.2, 4.8, 5.4 F-Series: Nobel BiocareNobelActive 3.5, 4.3, 5.0 H-Series: Biomet 3i OsseotiteCertain 3.25, 4.0, 5.0 I-Series: Biomet 3i Osseotite3.25, 3.75, 4.0, 5.0 K-Series: Nobel BiocareBrånemark 3.3, 3.75, 4.0, 5.0 L-Series: Straumann Bone Level3.3, 4.1, 4.8 N-Series: Straumann Standard3.3, 4.1, 4.8 R-Series: Zimmer TaperedScrew-Vent 3.3, 3.7, 4.1, 4.7, 6.0 S-Series: Astra TechOsseoSpeed 3.5/4.0, 4.5/5.0 T-Series: Dentsply FriadentFrialit/XiVE 3.4, 3.8, 4.5, 5.5 Y-Series: Dentsply FriadentAnkylos 3.5, 4.5, 5.5, 7.0	E-Series: Nobel Biocare ReplaceSelect 3.5, 4.3, 5.0, 6.0 F-Series: Nobel BiocareNobelActive 3.5, 4.3, 5.0 H-Series: Biomet 3i OsseotiteCertain 3.25, 4.0, 5.0 I-Series: Biomet 3i Osseotite3.25, 3.75, 4.0, 5.0 K-Series: Nobel BiocareBrånemark 3.3, 3.75, 4.0, 5.0 L-Series: Straumann Bone Level3.3, 4.1, 4.8 N-Series: Straumann Standard3.3, 4.1, 4.8 R-Series: Zimmer TaperedScrew-Vent 3.3, 3.7, 4.1, 4.7, 6.0 S-Series: Astra TechOsseoSpeed 3.5/4.0, 4.5/5.0 T-Series: Dentsply FriadentFrialit/XiVE 3.4, 3.8, 4.5, 5.5 Y-Series: Dentsply FriadentAnkylos® 3.5, 4.5, 5.5, 7.0	3.3, 4.1 and 4.8 mm	EquivalentThe subject device diameters arewithin the range of diameters for theprimary predicate devices, so that nonew concern is raised.					The materials indicated for thesubject devices are within the rangeof materials cleared for use with thepredicate devices.
Implant-to-AbutmentConnection /Compatible implantsystems	Nobel Biocare Replace™ Select Dentsply® Implants/ASTRA TECHOsseoSpeed® 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® AstraTech OsseoSpeed™ Dentsply Friadent® Frialit/XiVE® Dentsply Friadent® Ankylos®	NNC (Narrow Neck CrossFit),RN (Regular Neck),WN (Wide Neck),NC (Narrow CrossFit),RC (Regular CrossFit)	EquivalentMost of the connection styles of thesubject devices are within the rangeof connections of the primarypredicate devices. The newconnection has been assessedthrough fatigue testing.	Cement used in deviceperformance testingCement to fix patient-specific coping toTiBase according toIFU	Multilink Hybrid Abutment Cement,cleared by FDA under K130436Multilink Hybrid Abutment Cement,cleared by FDA under K130436	Multilink Hybrid Abutment Cement,cleared by FDA under K130436Multilink Hybrid Abutment Cement,cleared by FDA under K130436		Identical
RestorationAngulation(s)	Up to 30°	Up to 30°	Up to 30°	Identical
CAD/CAM SystemSterility	Straumann CARES SystemDelivered non-sterile; to be sterilizedby user	Straumann CARES SystemDelivered non-sterile; to be sterilizedby user	Straumann CARES SystemDelivered non-sterile; to be sterilizedby user	Identical
Sterilization by enduser	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.

Regulation Number and Section

§ 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.)