Straumann® Bone Level Tapered Implants Ø2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants 02,9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments).

The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant comection.

Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. 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.

Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

Device Description

The Straumann Ø2.9mm Bone Level Tapered (BLT) Implants are apically tapered implants with an external diameter of Ø2.9 mm and lengths of 10 mm, 12 mm, and 14 mm. The implants are manufactured utilizing the Roxolid material and are finished with either the SLA® or SLActive® surface. The prosthetic platform is identified as SC (Small CrossFit®) which corresponds to a shoulder diameter of Ø2.9 mm.

The closure cap and healing abutments are manufactured from Titanium Grade 4 and are anodized blue for identification purposes. The closure cap is conical and has a height of 0.5 mm. The healing abutments are seated in the implant with a basal screw which is manufactured from TAN. The healing abutments are oval in shape and are available in four different heights ranging between 2.0 mm and 6.5 mm.

The temporary abutments are manufactured from TAN and are anodized blue for identification purposes. The temporary abutments are oval in shape in order to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The temporary abutments are seated in the implant with a basal screw which is also manufactured from TAN.

There are three components to the Straumann® SC Variobase™ Abutments:

Straumann® SC Variobase™ Abutments (Ti-base)
Prosthetic restoration (coping and/or crown)
Basal Screw

The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.

The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:

Cast materials:
- Type 4 metals (ISO 22674)
- Base metal alloys (e.g., cobalt-chromium (CoCr))
- Noble metal alloys (e.g., gold alloy)
Press materials:
- IPS e.max® Press Ceramic (K120053)
Digital materials:
- coron®
- zerion® LT
- polycon® ae

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 Straumann® SC CARES® Abutments are customized abutments manufactured from TAN. The abutments are designed by the customer by scanning the intraoral situation and designing of the shape with the CAD module of the integrated software. The design data is then sent to Straumann where the fabrication of the customized abutment is performed. The TAN alloy is capable of being directly veneered once the abutment is subject to a heat treatment step by the dental laboratory technician. A finished crown may also be cemented to the subject abutments rather than by direct veneer. The abutments will be delivered with the corresponding basal screw.

AI/ML Overview

The provided document (K162890) describes the regulatory submission for Straumann dental implants and associated components. However, it does not contain information about studies proving the device meets acceptance criteria for performance metrics related to diagnostic accuracy, such as sensitivity, specificity, or AUC, as these types of metrics are typically associated with diagnostic or AI-powered devices.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through various non-clinical tests. The "acceptance criteria" here relate to the successful completion of these engineering and safety tests, rather than clinical performance metrics for diagnostic capability.

Therefore, the requested information cannot be fully provided in the format desired for diagnostic devices because this submission deals with dental implants, not a diagnostic AI.

However, I can extract the information related to the performance testing that was conducted to support the substantial equivalence claim.

Acceptance Criteria and Device Performance (Not applicable in the typical sense for diagnostic AI):

The document does not present acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) because the devices (dental implants and abutments) are not diagnostic AI devices. Instead, the "performance testing" focuses on engineering, biocompatibility, and sterilization validations to demonstrate substantial equivalence to predicate devices.

Summary of Performance Testing Conducted (which can be seen as meeting "acceptance criteria" for safety and efficacy in this context):

Sterilization Validation (Section 5.8.1):
- Acceptance Criteria: Validation according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
- Reported Device Performance: The sterilization process for SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments was validated.
Biocompatibility Testing (Section 5.8.2):
- Acceptance Criteria: Compliance with ISO 10993-1:2009 and 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 should have identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices, raising no new biocompatibility issues.
- Reported Device Performance: The subject devices have identical biocompatibility characteristics to the primary and reference predicate devices. Therefore, no additional biocompatibility testing was required or performed.
Software Verification and Validation Testing (Section 5.8.3): (Applicable to CARES Visual software for abutment design, which is part of the manufacturing process, not a diagnostic AI)
- Acceptance Criteria: Compliance with FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff".
- Reported Device Performance: Software verification and validation testing were conducted; the software for the device (CARES Visual) was considered a "moderate" level of concern.
Bench Testing (Section 5.8.4):
- Acceptance Criteria: Compliance with the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" for dynamic fatigue, static strength, and insertion torque tests.
- Reported Device Performance: Dynamic fatigue, static strength, and insertion torque tests demonstrated the Straumann® Ø2.9 mm Bone Level Tapered implants, SC Temporary Abutments, SC Variobase Abutments, and SC CARES abutments are equivalent to the predicate and reference devices.

Regarding the specific questions about diagnostic AI studies:

A table of acceptance criteria and the reported device performance: As explained above, not applicable for diagnostic metrics. The performance relates to engineering and safety tests.
Sample size used for the test set and the data provenance: Not applicable. The "tests" mentioned are non-clinical engineering and bench tests, not studies on patient data for diagnostic evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no diagnostic test set or ground truth in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a diagnostic AI scenario. The "ground truth" for the bench tests would be the established engineering standards and physical properties of the materials.
The sample size for the training set: Not applicable, as there is no AI training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged to suggest a sense of movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 8, 2017

Straumann USA, LLC % Jennifer Jackson Director, Regulatory Affairs & Quality 60 Minuteman Road Andover, Massachusetts 01810

Re: K162890

Trade/Device Name: Straumann Ø2.9 mm Bone Level Tapered Implants, SC Closure Cap. SC Healing Abutments, SC Temporary Abutments, SC Variobase Abutments. SC CARES Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 16, 2017 Received: February 17, 2017

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 (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.

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

{1}------------------------------------------------

the quality systems (OS) 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 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 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,

Lori A. Wiggins -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

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Indications for Use

510(k) Number (if known)

K162890

Device Name

Straumann® Ø2.9 mm Bone Level Tapered Implants, SC Closure Cap, SC Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutments

Indications for Use (Describe)

The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

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.

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Straumann® Ø2.9 mm Bone Level Tapered Implants

510(k) Summary

510(k) Summary 5

Submitter's Contact Information 5.1

Straumann USA, LLC (on behalf of Institut Straumann AG)

60 Minuteman Road

Andover, MA 01810

Phone Number:	1-978-747-2509
---------------	----------------

Fax Number: 1-978-747-0023

Contact Person: Jennifer M. Jackson, MS

Date of Submission: March 6, 2017

5.2 Name of the Device

Trade Names:	Straumann® Ø2.9 mm Bone Level Tapered Implants
	SC Closure Cap
	SC Healing Abutments
	SC Temporary Abutments
	SC Variobase® Abutments
	SC CARES® Abutments
Common Name:	Endosseous Dental Implant
	Endosseous Dental Implant Abutment
Classification Name:	Endosseous Dental Implant
Regulation Number:	§872.3640
Classification:	Class II
Product Codes:	DZE, NHA

5.3 Predicate Device(s)

Primary Predicate:

K140878 – Straumann Bone Level Tapered Implant

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Straumann® Ø2.9 mm Bone Level Tapered Implants

510(k) Summary

Reference Devices:

K120414 OsseoSpeed™ Plus
K130808 Straumann Healing Abutments, Healing Caps, and Closure Screws
K092814 Straumann NC Temporary Abutments
K120822 Straumann CARES Variobase Abutments
K142890 Straumann Variobase Abutments
K150203 Medentika CAD/CAM Abutments
K150899 Straumann CARES TAN Abutments
K062129 P.004 Implants

5.4 Device Description

There are three components to the Straumann® SC Variobase™ Abutments:

Straumann® SC Variobase™ Abutments (Ti-base) ●
Prosthetic restoration (coping and/or crown) .
Basal Screw .

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Straumann® Ø2.9 mm Bone Level Tapered Implants

510(k) Summary

The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:

Cast materials: .
- o Type 4 metals (ISO 22674)
- Base metal alloys (e.g., cobalt-chromium (CoCr)) o
- Noble metal alloys (e.g., gold alloy) o
Press materials: ●
- o IPS e.max® Press Ceramic (K120053)
. Digital materials:
- o coron®
- o zerion® LT
- o polycon® ae

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.

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Straumann® Ø2.9 mm Bone Level Tapered Implants

510(k) Summary

5.5 Intended Use

The Straumann dental Implants are intended for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of patients with missing teeth.

Closure Caps and Healing Abutments are intended for use with the Straumann® Bone Level Tapered Implants Ø2.9 mm to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.

Straumann® SC Temporary Abutments are intended to be placed into Straumann dental implants to provide support for temporary crowns and bridges.

Straumann® SC Variobase® Abutments are intended to be placed into Straumann® Bone Level Tapered Implants Ø2.9 mm to provide support for individual crowns or bridges. Straumann® SC CARES® abutments are intended for use as an aid in prosthetic rehabilitation.

5.6 Indications for Use

Straumann® Bone Level Tapered Implants ø2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants ø2.9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth or multiple-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments).

The Straumann® Bone Level Tapered Implants ø2.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection.

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Straumann® Ø2.9 mm Bone Level Tapered Implants

510(k) Summary

Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Straumann® SC Temporary Abutments have a maximum duration of usage of 180 days. Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. 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.

Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

5.7 Technological Characteristics

5.7.1 Straumann® Ø2.9 mm Bone Level Tapered Implants

The technological principles are the same for the subject and primary predicate devices. Both the subject device and primary predicate device are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. The subject devices are specifically indicated for the lateral incisor in the upper jaw and the lower incisors. The indications for use for the subject devices are within the scope of the indications for use for the primary predicate device. The narrower indications do not change the intended use. The main differences in the technological characteristics between the subject device and the primary predicate device are the implant diameter (Ø2.9 mm vs. Ø3.3, Ø 4.1 and Ø 4.8 mm) and the implant to abutment connection (Small CrossFit® (SC) versus Narrow CrossFit® (NC) and Regular CrossFit® (RC)). The technological characteristics of the subject devices are compared to the primary and reference predicate in Table 1.

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Straumann® Ø2.9 mm Bone Level Tapered Implants

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE	REFERENCEPREDICATE DEVICE
K Number	Subject Device	K140878	K120414
Material	Titanium-13 Zirconiumalloy (Roxolid®)	Titanium-13 Zirconiumalloy (Roxolid®)	Commercially puretitanium, grade 4
SurfaceTreatment	SLA® and SLActive®	SLA® and SLActive®	OsseoSpeed™
Implant toAbutmentConnection	Small CrossFit® (SC)	Narrow CrossFit® (NC)Regular CrossFit® (RC)	Six position connection
ImplantDiameter	Ø2.9 mm	Ø3.3, Ø4.1, and Ø4.8 mm	Ø3.0 mm
Implant Length	10, 12, and 14 mm	8, 10, 12, and 14 mm	8, 9, 11, 13, and 15 mm
Implant Design	Straight implant with apicaltaper	Straight implant with apicaltaper	Straight implant with apicaltaper

510(k) Summary

Table 1 – Comparison of subject device versus primary and reference predicate devices (Dental Implants)

5.7.2 Straumann® Closure Cap and Healing Abutments

The technological principles and intended use are identical for the subject and reference predicate devices. The intended use is to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The main differences in the technological characteristics between the subject and reference predicate devices are the shape and diameter of the devices. The subject devices are dimensionally smaller to accommodate the smaller diameter implant. The technological characteristics of the subject devices are compared to the reference predicate in Table 2.

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Straumann® Ø2.9 mm Bone Level Tapered Implants

FEATURE	PROPOSED DEVICE	REFERENCE PREDICATEDEVICE
K Number	Subject Device	K130808
Material	Titanium Grade 4Ti-6Al-7Nb (Basal Screws)	Titanium Grade 4
Implant toAbutmentConnection	Small CrossFit® (SC)	Narrow CrossFit® (NC)
Diameter orMinor OvalDimension/Major OvalDimension	Closure Cap:Ø2.4 mmHealing Abutments:3.3/4.3 mm3.55/4.86 mm3.6/5.0 mm	Closure Cap:Ø2.77 and Ø3.05 mmHealing Abutment:Ø3.6
Overall Length	Closure Cap:5.8 mmHealing Abutment (including basal screw):7.0, 8.5, 10.0, 11.5 mm	Closure Cap:6.25 and 6.8 mmHealing Abutment:8.1, 9.6, 11.1 mm
Gingival Heights	Closure Cap:0.5 mmHealing Abutments:2.0, 3.5, 5.0 and 6.5 mm	Closure Cap:0 mm and 0.5 mmHealing Abutments:2.0, 3.5, and 5.0 mm

510(k) Summary

Table 2 – Comparison of subject device versus reference device (SC Closure Cap and SC Healing Abutments)

Temporary Abutments 5.7.3

The technological principles and intended use are identical for the subject and reference predicate devices. The devices are intended to be placed into Straumann dental implants to provide support for temporary crowns and bridges. The main differences in the technological characteristics between the subject and reference predicate devices are the shape and diameter of the devices. The subject devices are dimensionally smaller to accommodate the smaller diameter implant. The technological characteristics of the subject devices are compared to the reference predicate in Table 3.

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Straumann® Ø2.9 mm Bone Level Tapered Implants

FEATURE	PROPOSED DEVICE	REFERENCE PREDICATE DEVICE
K Number	Subject Device	K092814
Material	Ti-6Al-7Nb	Ti-6Al-7Nb
Implant toAbutmentConnection	Small CrossFit® (SC)	Narrow CrossFit® (NC)
Diameter orMinor OvalDimension/Major OvalDimension	3.3/4.3 mm	Ø3.5 mm
Overall Length	13.2, 14.2, and 15.2 mm	13.75 mm
Gingival Heights	1.0, 2.0, and 3.0 mm	1.0 mm

510(k) Summary

Table 3 - Comparison of subject device versus reference predicate device (SC Temporary Abutments)

5.7.4 SC Variobase® Abutments

The technological principles and intended use are identical for the subject and reference predicate devices. The devices are intended to be placed into dental implants to provide support for individual crowns or bridges. The subject devices are specifically indicated for the lateral incisor in the upper jaw and the lower incisors. The indications for use for the subject devices are within the scope of the indications for use for the reference predicate devices. The narrower indications do not change the intended use.

The main differences in the technological characteristics between the subject and reference predicate devices are the shape and diameter of the devices. The subject devices are dimensionally smaller to accommodate the smaller diameter of the implant. The subject devices also have only two retention features compared to the Straumann reference predicate device which has four retention features. The Medentika reference predicate has one retention feature. The technological characteristics of the subject devices are compared to the reference predicate in Table 4.

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Straumann® Ø2.9 mm Bone Level Tapered Implants

FEATURE	PROPOSED DEVICE	REFERENCEPREDICATE DEVICES	REFERENCEPREDICATE DEVICES
K Number	Subject Device	K142890/K120822	K150203R Series
Material	Ti-6Al-7Nb	Ti-6Al-7Nb	Ti-6Al-4V
Implant to AbutmentConnection	Small CrossFit® (SC)	Narrow CrossFit® (NC)Regular CrossFit® (RC)Narrow Neck CrossFit®(NNC)Regular Neck (RN)Wide Neck (WN)	2.5mmD InternalHexagon
Diameter or MinorOval Dimension/Major OvalDimension	3.3/4.3 mm	Ø3.8 - 7.0 mm	Ø3.5 – 5.7 mm
Overall AbutmentHeight	6.7 – 8.7 mm	5.9 – 8.9 mm	6.15 – 7.54 mm
Coping/ CrownMaterial	Traditional Workflow:Type 4 metals (ISO22674)IPS e.max® PressCeramicDigital Workflow:coron® (permanent)zerion® LT (permanent)polycon® ae (temporary)	Traditional Workflow:Type 4 metals (ISO22674)IPS e.max® PressCeramicDigital Workflow:IPS e.max® CADCeramic (permanent)coron® (permanent)zerion® (permanent)polycon® ae (temporary)	Digital Workflow:zerion® (permanent)
Design Workflow	Wax-up or Open CAD	Wax-up or Open CADCARES® Visual	CARES® Visual
ManufacturingWorkflow	Traditional casting orpressingorStraumann Milling	Traditional casting orpressingorStraumann Milling	Straumann Milling
Mode of Action	Screw-retained orcement retained	Screw-retained orcement retained	Screw-retained orcement retained

510(k) Summary

Table 4 - Comparison of subject device versus reference device (SC Variobase Abutments)

5.7.5 SC CARES® Abutments

The technological principles and intended use are identical for the subject and reference predicate devices. The devices are intended for use as an aid in prosthetic rehabilitation. The main differences in the technological characteristics between the subject and reference predicate devices are the diameter and the dimension for the abutment to implant connection. The technological characteristics of the subject devices are compared to the reference predicate in Table 5.

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Straumann® Ø2.9 mm Bone Level Tapered Implants

510(k) Summary

FEATURE	PROPOSED DEVICE	REFERENCE PREDICATE DEVICE
K Number	Subject Device	K150899
Material	Ti-6Al-7Nb	Ti-6Al-7Nb
Implant toAbutmentConnection	Small CrossFit® (SC)	Narrow CrossFit® (NC)
Abutmentcoronal design	CADCAM design process.Designs controlled by material-specificdesign limits in the CARES Visual CADsoftware, model verification performed bythe CAM software and milling blankdimensions used by the Straumannmilling center.	CADCAM design process.Designs controlled by material-specificdesign limits in the CARES Visual CADsoftware, model verification performed bythe CAM software and milling blankdimensions used by the Straumannmilling center.
CAD DesignLimits	Maximum Angulation 30°	Maximum Angulation 30°
	Emergence Offset 0.1 mm	Emergence Offset 0.1 mm
	Emergence Angle 65°	Emergence Angle 65°
	Minimum Thickness 0.4 mm	Minimum Thickness 0.4 mm
	Smooth Distance 0.5 mm	Smooth Distance 0.5 mm
Coping/ Crown	Cemented	Cemented
	Directly veneerable	Directly veneerable

Table 5 - Comparison of subject device versus reference device (SC CARES Abutments)

5.8 Performance Testing

The following performance data were provided in support of the substantial equivalence determination.

Sterilization Validation 5.8.1

The sterilization process for the SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".

5.8.2 Biocompatibility Testing

Table 32ISO 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

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Straumann® Ø2.9 mm Bone Level Tapered Implants

510(k) Summary

Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.

The subject devices have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the primary and reference predicate devices. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.

5.8.3 Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided according to the FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". The software for this device was considered as a "moderate" level of concern as a failure in the Straumann CARES Visual software could result in a non-fitting or poor-fitting restoration or framework.

5.8.4 Bench Testing

Dynamic fatigue, static strength, and insertion torque tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann® Ø2.9 mm Bone Level Tapered implants, SC Temporary Abutments, SC Variobase Abutments, and SC CARES abutments are equivalent to the predicate and reference devices.

5.9 Conclusion

The documentation submitted in this premarket notification demonstrates the Straumann® Ø2.9 mm Bone Level Tapered implants, SC Closure Caps and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments are substantially equivalent to the primary predicate and reference devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.