BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function.

BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.

BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only

BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentulous or partially edentulous patients.

Device Description

The BoneTrust® Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients.

The BoneTrust® Implants are bone level, root form implants constructed of commercially pure titanium (Grade 4) per ISO 5832-2, with a sand-blasted, acid-etched surface treatment. BoneTrust® Implants are screw- shaped dental implants with a Hexagon or conical torx internal connection.

BoneTrust® Dental Abutments are intended for cement-retained and screw-retained restorations. A cylindrical internal hexagon or conical torx allows connection to the BoneTrust® implant. BoneTrust® Dental Abutments are available in different designs

AI/ML Overview

This document is a 510(k) summary for the BoneTrust® Implant System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a standalone study for novel performance metrics. Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable.

However, I can extract the information provided regarding non-clinical testing used to support substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a novel AI device. Instead, it relies on demonstrating "substantial equivalence" through non-clinical testing to legally marketed predicate devices. The "reported device performance" is essentially that the device performed comparably to predicate devices in the described tests.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility in accordance with ISO 10993 series	Tests (including cytotoxicity per ISO 10993-5) support substantial equivalence to legally marketed predicate devices.
Fatigue strength of the implant-abutment interface	Tested for representative samples in accordance with ISO 14801. Results support substantial equivalence to legally marketed predicate devices.
Sterilization validation (for non-sterile devices)	Validation conducted per ISO 17665-1 and ISO 17665-2 for pre-vacuum steam sterilization (wrapped cycle), demonstrating a sterility assurance level (SAL) of 10^-6.
Sterilization validation (for sterile devices)	Validation conducted per ISO 11137-1 and 11137-2 for Beta-radiation sterilization. Shelf life testing per ISO 11607-1 and ASTM F1980 (accelerated and real-time aging). LAL testing per USP 85 and FDA Guidance.
Implant Surface Analysis	Investigation using EDX, SEM, and BSE. Results support substantial equivalence to legally marketed predicate devices.
Performance of BoneTrust® Short Implants	Comparative surface area analysis, comparative bone-to-implant contact study (using animal histology), and comparative pull-out strength test. Results support substantial equivalence to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for the test sets in the non-clinical studies. It mentions "representative samples" for fatigue testing. Data provenance is not specified beyond being non-clinical testing performed to support substantial equivalence to legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a 510(k) submission for a physical medical device (dental implants and abutments), not an AI/software device requiring ground truth establishment by human experts for diagnostic or similar tasks. The "ground truth" for the non-clinical tests would be the measurement results from the tests themselves (e.g., cytotoxicity levels, fatigue limits, physical characteristics).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this is for a physical device and involves objective non-clinical tests rather than subjective human interpretation needing adjudication.

5. 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. This is not an AI-assisted diagnostic or interpretation device.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical studies performed, the "ground truth" would be objective measurements obtained through standardized testing methods, such as:

Biocompatibility: Laboratory results (e.g., cell viability in cytotoxicity tests).
Fatigue testing: Load cycles to failure or endurance limit under specified conditions, as per ISO 14801.
Sterilization: Sterility Assurance Level (SAL), microbial ingress testing, package integrity.
Implant Surface Analysis: Microscopic imagery (SEM, BSE) and elemental composition data (EDX).
Short Implants Performance: Quantitative measurements from comparative surface area analysis, histological examination for bone-to-implant contact (animal study), and force measurements for pull-out strength tests.

8. The sample size for the training set

Not applicable. There is no training set mentioned for this physical device.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this physical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

March 11, 2019

Medical Instinct Deutschland GmbH % Andre Weingerl RA Consultant WRC Consulting Am Hohsetter 1A Steislingen 78256 GERMANY

Re: K182313

Trade/Device Name: BoneTrust® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 6, 2019 Received: February 13, 2019

Dear Andre Weingerl:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

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) K182313

Device Name BoneTrust® Implant System

Indications for Use (Describe)

BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.

BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only

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)

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medical i

K182313

510(k) Summary

Date Prepared: 2019-03-09

APPLICANT: Medical Instinct Deutschland GmbH Graseweg 24 37120 Bovenden Germany Tel.: +49 5593 95196 Fax.: +49 5593 95195

E-Mail: info@medical-instinct.de Internet: www.medical-instinct.de

CONTACT PERSON: Jan Worlitz Managing Director Tel.: +49 5593 95196 E-Mail: worlitz@medical-instinct.de

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medica

Device Name 1.

Trade Names:	BoneTrust® Implant System
Classification Name:	Endosseous dental implant

2. Classification Product Code / Subsequent Code

BoneTrust® Implant System can be classified according to following Device Name and Product Code:

Product Code:	DZE
Device Class:	2
Classification Panel:	Dental
Regulation number:	21 CFR 872.3640
Secondary Product Code:	NHA

3. Predicate device

. Primary Predicate Device

Straumann Dental Implant System; Stramann USA, LLC

#K150938

Reference Devices .

CAMLOG Abutments; Altatec GmbH	#K083496
Nobelactive Multi Unit Abutments; Nobel Biocare AB	#K072570
Straumann RN synOcta UCLA Gold Abutment; Institut Straumann AG	#K041295
Conelog Implant System; Altatec GmbH	#K113779
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS	#K130808
SIC Invent Dental Implant Systems; SIC Invent AG	#K173207
BIOMET 3i Dental Abutments	#K072642
XIVE@ Dental Implant System	#K021318
Healing Cap Multi-Unit Titanium, Nobel Biocare AB	#K171142

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Device Description 4.

The BoneTrust® Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients.

Implants 4.1.

Bone Trust Implants are provided in the following specifications:

Representative Picture	Specification	Value
Image: Dental Implant	Sizes - Diameter x length(mm)	3.4 x 8.0 / 3.4 x 10.0 / 3.4 x 11.5 / 3.4 x 13.0 / 3.4 x 14.54.0 x 6.5 / 4.0 x 8.0 / 4.0 x 10.0 / 4.0 x 11.5 / 4.0 x 13.0 /4.0 x 14.55.0 x 6.5 / 5.0 x 8.0 / 5.0 x 10.0 / 5.0 x 11.5 / 5.0 x 13.0
	Design	Conical screw implantSelf-tapping screw designIntegrated "platform switching"Internal connection hexagonal / internal connection with conical torx socket
	Material	Titan Grade 4 (ISO 5832-2:1999 / ASTM F67-06:2006)
	Surface	Micro-structured blasted etched surface passivated
	Packaging / Sterilization	Sterile packed in blister; Sterilized by beta irradiation

4.2. Abutments

4.2.1. Esthetic Abutments

BoneTrust® Esthetic and Wide Body Abutments are premanufactured single-piece abutments constructed of titanium alloy per ISO 5832-3 and intended to be used for cemented single-tooth and bridge restorations as well as temporary single tooth restorations. BoneTrust® Esthetic Abutments are available in the following shapes:

Esthetic Abutments
Available sizes	Platform Diameter	Sizes (Angulation, Gingival Height (GH))
	Ø3.4	0°: GH 0.5, 2.5, 4.5mm15°: GH 0.5, 2.5mm20°: GH 0.7mm
	Ø4.0	0°: GH 0.5, 2.5, 4.5mm15°: GH 0.5, 2.5mm
	Ø5.0	0°: GH 2.5mm15°: GH 0.5mm, 2.5mm
Total Abutment Height [mm]	10.1 to 11.6
Design	Hexagonal connection / conical torx socket connection
Material	Titan Grade 5 (ISO 5832-3 / ASTM F136)
Surface	Anodized

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Esthetic Abutments
	Packaging / Sterilization
	Packed in an individual PE bag - Must be sterilized by the user.
End User Modification	Wall thickness/diameter

	Post height

	Angulation and divergence

	Gingival height
	No modifications allowed
	Connection platform
	No modifications allowed
	Method of modification
	Hand Tools only

Wide Body Abutments 4.2.2.

BoneTrust® Wide Body Abutments are premanufactured single-piece abutments constructed of titanium alloy per ISO 5832-3 and intended to be used for cemented single-tooth and bridge restorations as well as temporary single tooth restorations.

Wide Body Abutment and Wide Body Abutment cone+ feature bigger body diameter compared to the Esthetic Abutment / Esthetic Abutment cone+ which allows the option of switching to a wider prosthetic platform

The abutment might be shortened up to a minimum abutment post height of 5 mm. the abutments are not intended for angular correction, correction of diameter or taper

Wide Body Abutments
Image: dental abutment	Angulation (°)	0
	Available Sizes	Platform Diameter	Gingival Height (GH)
		3.4 mm / 4.0 mm	3.0 mm
		5.0 mm	3.0 mm
	Total Abutment Height [mm]	11.2 to 12.2
	Design	Hexagonal connection / conical torx socket connection
	Material	Titan Grade 5 (ISO 5832-3 / ASTM F136)
	Surface	Anodized
	Packaging / Sterilization	Packed in an individual PE bag - Must be sterilized by the user.
	End User Modification	Wall thickness/diameter
		Post height
		Angulation and divergence
		Gingival height
		Connection platform
		Method of modification

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4.2.3. UCLA Abutments

BoneTrust® UCLA Abutments are intended to be used as a pattern for the creation of customized veneered crowns for cemented or screw retained single-tooth and bridge restorations. BoneTrust® UCLA Abutments are available in the following shapes:

UCLA Abutments
Image: [abutments]	Angulation [°]	0
	Platform Diameter [mm]	3.4 / 4.0 / 5.0
	Body Diameter [mm]	2.8
	Cylinder Height [mm]	3.0
	Design	Hexagonal connection with / without rotation stop
	Design	Conical torx socket connection with / without rotation stop
	Material for Precious Alloys	Heraplat Au 61%, Pt 23.8 %, Pd 15 %, Rh 0.2 %
	Material for Non Precious Alloys	PtIr20% (ISO 22674)
	Surface	Anodized
Packaging / Sterilization	Packed in an individual PE bag - Must be sterilized by the user.
End User Modification	No modification allowed to the abutmentBurn-out plastic sleeve may be shortened down to a minimum height of 4 mm

4.2.4. Direct Abutment

BoneTrust® Direct Abutments are premanufactured multi-unit abutments constructed of titanium alloy per ISO 5832-3 and intended to be used for splinted and occlusally screwed prosthetics, such as bridges, hybrid prostheses and cast bars,. BoneTrust® Direct Abutments are two piece abutments intended for use in combination with Auro Base Direct Abutments. BoneTrust® Direct Abutments are available in the following shapes:

	Direct Abutments
Available Sizes	Angulation	Size (diameter in mm x Gingival Height in mm)
	0°	3.4/4.0 x GH 1.03.4/4.0 x GH 3.0
	20°	3.4/4.0 x GH 2.0
	30°	3.4/4.0 x GH 2.0
Total Abutment Height [mm]	9.1 to 12.2
Design	Hexagonal connection / conical torx socket connection
Material	Titan Grade 5 (ISO 5832-3 / ASTM F136)
Surface	Anodized
Compatible Abutments	BonteTrust® Direct Healing AbutmentsBoneTrust® AuroBase Abutments
Packaging / Sterilization	packed in an individual PE bag - Must be sterilized by the user.
End User Modification	No modification allowed

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4.2.5. AuroBase Direct Abutments

BoneTrust® AuroBase Direct Abutments are premanufactured multi-unit abutments intended to be used as a pattern for the creation of customized veneered crowns for splinted and occlusally screwed prosthetics, such as bridges, hybrid prostheses and cast bars. BoneTrust® AuroBase Direct Abutments are two piece abutments intended for use in combination with Direct Abutments.

	Auro Base Abutment
	Angulation (°)	0
	Cylinder Height (mm)	3.2
	Platform diameter D (mm)	3.4 / 4.0
	Body diameter (mm)	3.15
	Design	Hexagonal connection / conical torx socket connection
	Material for Precious Alloys	Heraplat Au 61%, Pt 23.8 %, Pd 15 %, Rh 0.2 %
	Material for Non Precious Alloys	Ptlr20% (ISO 22674)
	Surface	Anodized
	Compatible Abutments	BonteTrust® Direct Abutments
	Packaging / Sterilization	packed in an individual PE bag - Must be sterilized by the user.
	End User Modification	No modification allowed to the abutmentBurn-out plastic sleeve may be shortened down to a minimum height of 4 mm

4.2.6. Telescopic Abutment

BoneTrust® Telescopic Abutments are constructed of titanium alloy per ISO 5832-3 and intended to be used for fixation of friction retained removable restorations and bridges. BoneTrust® telescopic Abutments are available with hexagon or conical torx connection with 3.4 / 4 mm Platform.


Angulation (°)	0
Platform diameter D (mm)	3.4 / 4
Body diameter (mm)	5
Total Abutment Height [mm]	8.0 to 10.8
Design	Hexagonal connection / conical torx socket connection
Material	Titan Grade 5 (ISO 5832-3 / ASTM F136)
Surface	Anodized
Packaging / Sterilization	packed in an individual PE bag - Must be sterilized by the user.
End User Modification	Wall thickness/diameter	No modifications allowed
	Post height	No modifications allowed
	Angulation and divergence	Maximum Taper of 5° to correct diver-gence between implants
	Gingival height	No modifications allowed
	Connection platform	No modifications allowed
	Method of modification	Hand Tools only

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Healing Abutment 4.2.7.

BoneTrust® Healing Abutments are premanufactured abutments constructed of titanium alloy per ISO 5832-3 and intended to be used temporarily during the healing period of the BoneTrust® implant to prepare gingival tissue for acceptance of the final abutment. BoneTrust® Healing Abutments are available in the following shapes:

	Healing Abutment
	Angulation (°)	0
Available Sizes	Platform Diameter	Gingival Height (GH)
	3.4 mm	1.5 mm, 3.0 mm, 5.0 mm, 7.0 mm
	4.0 mm	1.5 mm, 3.0 mm, 5.0 mm
5.0 mm	1.5 mm, 3.0 mm, 5.0 mm
Total Abutment Height [mm]	6.5 to 12.6
Design	Hexagonal connection / conical torx socket connection
Material	Titan Grade 5 (ISO 5832-3 / ASTM F136)
Surface	Anodized
Packaging / Sterilization	packed in an individual PE bag - Must be sterilized by the user.
Maximum intraoral Use	180 Days
Load	Non-occlusal load

Direct Healing Abutment 4.2.8.

BoneTrust® Direct Healing Abutments are premanufactured abutments designed to be mounted on BoneTrust® Direct Abutments. They are constructed of titanium alloy per ISO 5832-3 and indicated for use with the BoneTrust® Direct Abutments during the healing period of the BoneTrust® implant to prepare gingival tissue for acceptance of the final abutment. They are intended for use of up to 180 days during endosseous and gingival healing and are for non-occlusal restorations. BoneTrust® Direct Healing Abutments are available in the following shapes:

Direct Healing Abutment
Image: Direct Healing Abutment	Angulation [°]	0
	Diameter [mm]	4.9
	Length [mm]	4.75
	Material	Titan Grade 5 (ISO 5832-3 / ASTM F136)
	Surface	Anodized
	Packaging / Sterilization	Packed in an individual PE bag - Must be sterilized by the user.
	Maximum Intraoral Use	180 Days
	Load	Non-occlusal load

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4.2.9. Healing Abutments Wide Body

BoneTrust® Wide Body Healing Abutments are premanufactured abutments constructed of titanium alloy per ISO 5832-3 and indicated for use with the BoneTrust® Implant System during the healing period of the BoneTrust® implant to prepare gingival tissue for acceptance of the final abutment. They are intended for use of up to 180 days during endosseous and gingival healing and are for non-occlusal loading of provisional restorations. BoneTrust® Healing Abutments Wide Body are available in the following shapes:

Healing Abutment - Wide Body
Image: dental abutments	Angulation (°)	0
Image: dental abutments	Available Sizes	Platform Diameter	Gingival Height (GH)
		3.4 mm / 4.0 mm	3.0 mm, 5.0 mm
		5.0 mm	3.0 mm, 5.0 mm
Image: dental abutments	Total Abutment Height [mm]	8.6 to 10.6
Image: dental abutments	Design	Hexagonal connection / conical torx socket connection
Image: dental abutments	Material	Titan Grade 5 (ISO 5832-3 / ASTM F136)
Image: dental abutments	Surface	Anodized
Image: dental abutments	Packaging / Sterilization	packed in an individual PE bag - Must be sterilized by the user.
Image: dental abutments	Maximum intraoral Use	180 Days
Image: dental abutments	Load	Non-occlusal load

5. Indications for Use

Bone Trust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading.

BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only

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Technological Characteristics and Substantial Equivalence 6.

6.1. Comparison of Indications for Use

The indications for use of the subject devices are compared to the primary predicate and reference devices in the following tables:

	Candidate:	Primary Predicate:	Discussion
Company	Medical Instinct DeutschlandGmbH	Straumann AG
DeviceName	BoneTrust® Implant System	Dental Implant System - Roxolid®SLA Implants	--
510(K)number	--	K150938	--
Indica-tions forUse	BoneTrust® Dental Implants aremedical devices intended to besurgically placed in the bone of themaxillary and/or mandibular archesto provide support for prostheticrestorations (crowns, bridges oroverdenture) in edentulous orpartially edentulous patients torestore a patients' chewing function.	Straumann® dental implants areindicated for oral endosteal implanta-tion in the upper and lower jaw and forthe functional and esthetic oral rehabil-itation of edentulous and partiallydentate patients. Straumann dentalimplants can also be used for immedi-ate or early implantation followingextraction or loss of natural teeth.Implants can be placed with immediatefunction on single-tooth and/or multipletooth applications when good primarystability is achieved and with appropri-ate occlusal loading, to restore chew-ing function. The prosthetic restora-tions used are single crowns, bridgesand partial or full dentures, which areconnected to the implants by thecorresponding elements (abutments).	Both implant-systems are indicatedfor placement in the patient's jaw toprovide support for prosthetic resto-rations in edentulous or partiallyedentulous patientsThe wording "maxillary and/or man-dibular arches" has the same mean-ing as "upper and lower jaw."Further minor differences in lan-guage do not impact the safety andeffectiveness of the subject device.
	Bone Trust® implants can also beused for immediate loading whensufficient primary stability isachieved and with appropriateocclusal loading.		Booth Implant Systems may be usedfor immediate loading when goodprimary stability is achieved.Minor differences in language do notimpact the safety and effectivenessof the subject device.
	BoneTrust® Short Dental Implantswith length 6.5 mm are intended fordelayed loading only		The inclusion of 6.5mm length spe-cific language does not impact thesafety and effectiveness of thesubject device.
	BoneTrust® Abutments andProsthetic parts are intended foruse with Bone Trust DentalImplants in the maxillary and/ormandibular arches to providesupport for crowns, bridges oroverdenture for edentulous orpartially edentulous patients.		Similar to primary predicate Indica-tions for UseThe wording "maxillary and/or man-dibular arches" has the same mean-ing as "upper and lower jaw."Further minor differences in lan-guage do not impact the safety andeffectiveness of the subject device.Further reference devices used fortechnological comparisons ofBoneTrust® Abutments do notinclude any component-specificlanguage that would raise any con-cern related to the safety and effec-tiveness of the subject devices.Further minor differences in lan-
			guage do not impact the safety andeffectiveness of the subject device

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Comparison of Technological Characteristics 6.2.

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:

6.2.1. BoneTrust® plus/cone+ implant

Company	Candidate:Medical InstinctDeutschland GmbH	Primary Predicate:Straumann AG	Reference Device:SIC Invent AG	Discussion
DeviceName	BoneTrust plus/cone+implant	Dental Implant System -Roxolid® SLA Implants	SIC Ace / Max Implants	--
510(K)number	--	K150938	K173207	--
Implantmaterial	Titan Grade 4 ASTM F67	Titanium Grade 4	Titanium Grade 4	Identical
ImplantType	Screw-type	Screw-type	Screw-type	Identical
Design	Conical	Conical	Conical	Identical
Load	Delayed and Immediate	Delayed and Immediate	Delayed and Immediate	Identical
Unitrestora-tion	Partial or total tooth loss	Partial or total tooth loss	Partial or total tooth loss	Identical
Single ortwo piece	Two pieces	Two pieces	Two pieces	Identical
Screwtype	Self-threading	Self-threading	Self-threading	Identical
Distal end	With thread	With thread	With thread	Identical
Implant toabutmentconnec-tion	Cylindrical Internal Hexa-gon or conical torx	Narrow Neck CrossFit®(NNC)Regular Neck (RN)Wide Neck (WN)	Hex 2.3Morse Taper	Results of fatiguetesting support thatdifferences do notraise any concernsin regard to safetyand effectiveness ofthe implant abutmentinterface.

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Company	Candidate:Medical InstinctDeutschland GmbH	Primary Predicate:Straumann AG	Reference Device:SIC Invent AG	Discussion
ImplantDimen-sions(DiameterX Length)	Ø3.4 X 8Ø3.4 X 10Ø3.4 X 11,5Ø3.4 X 13Ø3.4 X14,5Ø4 X 6.5Ø4 X 8Ø4 X 10Ø4 X 11.5Ø4 X 13Ø4 X 14.5Ø5 X 6.5Ø5 X 8Ø5 X 10Ø5 X 11.5Ø5 X 13	Ø3.3 X 8Ø3.3 X 10Ø3.3 X 12Ø3.3 X 14Ø4.1 X 6Ø4.1 X 8Ø4.1 X 10Ø4.1 X 12Ø4.1 X 14Ø4.8 X 6Ø4.8 X 8Ø4.8 X 10Ø4.8 X 12Ø4.8 X 14	Ø3.4 / 3.7 X 7.5Ø3.4 / 3.7 X 9.5Ø3.4 / 3.7 X 11,5Ø3.4 / 3.7 X 13Ø3.4 / 3.7 X14,5Ø4.0 / 4.2 X 6.0Ø4.0 / 4.2 X 7.5Ø4.0 / 4.2 X 9.5Ø4.0 / 4.2 X 11.5Ø4.0 / 4.2 X 13.0Ø4.0 / 4.2 X 14.5Ø4.5 / 4.7 X 6.0Ø4.5 / 4.7 X 7.5Ø4.5 / 4.7 X 9.5Ø4.5 / 4.7 X 11.5Ø4.5 / 4.7 X 13.0Ø4.5 / 4.7 X 14.5Ø5.0 / 5.2 / 4.7 X 6.0Ø5.0 / 5.2 / 4.7 X 7.5Ø5.0 / 5.2 / 4.7 X 9.5Ø5.0 / 5.2 / 4.7 X 11.5Ø5.0 / 5.2 / 4.7 X 13Ø5.0 / 5.2 / 4.7 X 14.5	Reference devicehas been used toaddress any dimen-sions not cleared inthe primary predi-cate submission.
Surfacetreatment	blasted-etched	SLA grit blast andacid etch surface	blasted-etched	Results of non-clinical testing sup-port that differencesin surface character-istics do not raiseany concerns inregard to safety andeffectiveness of theproposed devices

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6.2.2. Esthetic Abutments

Company	Candidate:	Reference Device:	Discussion
	Medical Instinct Deutschland GmbH	Altatech GmbH
Device Name	BoneTrust® Esthetic Abutments	CAMLOG Abutments	--
510(K) num-ber	--	K083496	--
Material	Titanium alloy TiAl4V	Titanium alloy TiAl4V	Identical
Surface	Anodized surface	Anodized surface	Identical
Size	Ø3.4:0°: GH 0.5, 2.5, 4.5mm15°: GH 0.5, 2.5mm20°: GH 0.7mmØ4.0:0°: GH 0.5, 2.5, 4.5mm15°: GH 0.5, 2.5mmØ5.0:0°: GH 2.5mm15°: GH 0.5mm, 2.5mmTotal Abutment height: 10.1 mm, 11.6 mm	Platform Diameter: ø 3.3 - 3.8 - 4.3 - 5.0 -6.0 mmBody Diameter: 4.5 to 8.0 mmGingival Height: 0.8 - 1.0 - 1.8 - 2.5 - 3.0 -4.5 mmTotal Abutment height: 8.7 mm - 11.7 mm	Substantially equiva-lentSizes are withinrange of the Refer-ence Device, exceptGingival Height (GH)of 0.5 / 0.7mm. Thisdifference does notraise any concernsin regard to safetyand effectiveness ofthe proposed devic-es
Connection	Cylindrical external Hexagon or andconical torx	Conical fitting	Results of dynamicfatigue testing sup-port that differencesin inner geometry donot raise any con-cerns in regard tosafety and effective-ness of the implantabutment interface.
Angulation	0° - 15° - 20°	0° - 15° - 20°	Identical

6.2.3. Wide Body Abutments

Company	Candidate:	Reference Device:	Discussion
	Medical Instinct Deutschland GmbH	Altatech GmbH
Device Name	BoneTrust® Wide Body Abutments	CAMLOG Abutments	--
510(K) num-ber	--	K083496	--
Material	Titanium alloy TiAl4V	Titanium alloy TiAl4V	Identical
Surface	Anodized surface	Anodized surface	Identical
Size	Platform Diameter: ø 3.4 - 4.0 - 5.0 mmBody Diameter: 7.4 / 7.6 mmGingival Height: 3.0 mmTotal Abutment height: 11.2 mm, 11.6 mm	Platform Diameter: ø 3.3 - 3.8 - 4.3 - 5.0 -6.0 mmBody Diameter: 4.5 to 8.0 mmGingival Height: 0.8 - 1.0 - 1.8 - 2.5 - 3.0 -4.5 mmTotal Abutment height: 8.7 mm - 11.7 mm	Sizes are withinrange of ReferenceDevice,

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Connection	Cylindrical external Hexagon or and coni-cal torx	Conical fitting	Results of dynamicfatigue testing sup-port that differencesin inner geometry donot raise any con-cerns in regard tosafety and effective-ness of the implantabutment interface
Angulation	$0^{\circ}$	$0^{\circ}$ - 15° - 20°	within range ofReference device

6.2.4. UCLA Abutments

Company	Candidate:Medical Instinct Deutsch-land GmbH	Reference Device:Institut Straumann AG	Reference DeviceBiomet 3i	Discussion
DeviceName	BoneTrust® Abutments	RN synOcta UCLA GoldAbutment	UCLA Gold / castableAbutment	--
510(K)number	--	K041295	K072642	--
Material	Heraplat Au 61%, Pt 23,8%,Pd, 15% Rh 0,2% /Platinum-Iridium-alloy(Ptlr20%)	Ceramicor®Au 60%, Pd 20%, Pt 19%,Ir 1%	Machined Gold Alloy	Materials conform to ISO22674 standard. Bio-compatibility Assess-ment and testing supportsubstantial equivalenceto reference device
MaterialBurn out-sleeve	POM	POM	Plastic	Identical to K041295
Size	Diameter ø 3.4, 4.0, 5.0 mmCylinder height: 3 mm	Diameter: 4.8, 6.5Cylinder height: 1.8 - 3.35mm	Diameterø 3.4, 4.1, 5.0, 6.0 mmCylinder height: 4 mm	Diameters are within therange of K072642, Cyl-inder Heights and totalheights are similar toK041295
Surface	Anodized	Anodized	Anodized	Identical
Connection	Cylindrical external Hexagonor conical torx	SynOcta connectionCone -octagon	Hexed and non-hexedconnection	Results of dynamicfatigue testing supportthat differences in innergeometry do not raiseany concerns in regardto safety and effective-ness of the implantabutment interface

6.2.5. Direct Abutment

Company	Candidate:	Reference Device:	Discussion
	Medical Instinct Deutschland GmbH	Nobel Biocare AB
Device Name	BoneTrust® Abutments	NobelActive Multi Unit Abutment – GoldCoping Multi-Unit Abutment	--
510(K) num-ber	--	K072570	--
Material	Titanium alloy TiAl4V	CP titanium (Grade 4)Titanium alloy TiAl4V	Identical

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Surface	Anodized surface	machined	Results of biocompati-bility assessment andtesting support thatdifferences in surfacetreatment do not raiseany concerns in regardto safety and effective-ness of the proposeddevice
Size	Diameter Ø 3.4, 4.0, 5.0 mmGingival Height: 1, 2, 3 mmTotal height: 9.1, 9.4 mm	Diameter Ø 3.5, 4.3, 5.0 mmGingival Height: 1, 2, 3, 4, 5 mmTotal height: not known	Platform Sizes areadapted to platformdiameter of the implantsystem. Minor differ-ences do not raise anyconcerns in regard tosafety and effectivenessof the proposed device
Connection	Cylindrical external Hexagon or and coni-cal torx	External Hex, Conical	Results of dynamicfatigue testing supportthat differences in innergeometry do not raiseany concerns in regardto safety and effective-ness of the implantabutment interface
Angulation	0°, 20°, 30°	0°, 17°, 30°	Within range of Refer-ence Device

6.2.6. Auro Base Abutment

Company	Candidate:	Reference Device:	Discussion
Company	Medical Instinct Deutschland GmbH	Nobel Biocare AB
Device Name	BoneTrust® Abutments	NobelActive Multi Unit Abutment - GoldCoping Multi-Unit Abutment	--
510(K) num-ber	--	K072570	--
Material	Heraplat Au 61%, Pt 23,8%, Pd, 15% Rh0,2% /Platinum-Iridium-alloy (PtIr20%)	Au 60%, Pd 20%, Pt 19%, Ir 1%	Materials conform toISO 22674 standard.Biocompatibility As-sessment and testingsupport substantialequivalence to refer-ence device
Material Burnout sleeve	POM	Burn out plastic	Substantially equivalent
Surface	Machined	machined	Identical
Size	Cylinder Height [mm]: 3.2Platform Diameter [mm]: 3.4 / 4.0Body Diameter [mm]: 3.1	Cylinder Height [mm]: 3.0Platform Diameter [mm]: Ø 3.5, 4.3, 5.0mmBody Diameter [mm]: not known	Results of dynamicfatigue testing supportthat differences inAbutment size do notraise any concerns inregard to safety andeffectiveness of theproposed device

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Connection	Cylindrical external Hexagon or and coni-cal torx	External Hex, Conical	Results of dynamicfatigue testing supportthat differences in innergeometry do not raiseany concerns in regardto safety and effective-ness of the implantabutment interface
Angulation	0°	0°	Identical

6.2.7. Telescopic Abutment

Company	Candidate:Medical Instinct Deutsch-land GmbH	Reference Device:Altatech GmbH	Reference DeviceDentsply Implants GmbH	Discussion
DeviceName	BoneTrust® TelescopicAbutments	CONELOG TelescopicAbutments	Friadent Telescopic Abut-ment	--
510(K)number	--	K113779	K021318	--
Material	Titanium alloy TiAl4V	Titanium alloy TiAl4V	Titanium alloy TiAl4V	Identical
Surface	Machined surface	Machined surface	Machined surface	Identical
Connection	Cylindrical external Hexa-gon or conical torx	Conical fitting	Hexagon connection	Results of dynamicfatigue testing supportthat differences ininner geometry do notraise any concerns inregard to safety andeffectiveness of theimplant abutmentinterface
Size	Diameter: 3,4 / 4 mm	Diameters: 3.8, 4.3, 5.0,and 6.0 mm	Diameters: 3.4, 3.8, 4.5, 5.5mm	Within range ofK021318
MaximumTaper	5°	5°	Not known	identical to K113779

6.2.8. Healing Abutment

Company	Candidate:Medical Instinct DeutschlandGmbH	Reference Device:SIC Invent AG	Discussion
DeviceName	BoneTrust® Healing Abutments	SIC Gingiva Shaper	--
510(K)number	--	K173207	--
Maximumintraoral use	180 Days	180 Days	Identical
Load	Non-occlusal loading	Non-occlusal loading	Identical
Material	Titanium alloy TiAl4V	Titanium alloy TiAl4V	Identical
Surface	anodized surface	anodized surface	Identical
Connection	Cylindrical external Hexagon orconical torx	Conical or cylindrical fitting	Results of dynamic fatigue test-ing support that differences ininner geometry do not raise anyconcerns in regard to safety andeffectiveness of the implant -abutment interface

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PlatformDiameter	Gingival Height(GH)	PlatformDiameter	Gingival Height (GH)
3.4 mm	1.5 mm, 3.0 mm,5.0 mm, 7.0 mm	3.0 mm	1.0 mm, 2.0 mm, 3.0mm, 4.0 mm, 5.0 mm,
4.0 mm	1.5 mm, 3.0 mm,5.0 mm	3.7 mm	1.0 mm, 1.5 mm, 2.0mm, 3.0 mm, 4.0 mm,5.0 mm, 7.0 mm
5.0 mm	1.5 mm, 3.0 mm,5.0 mm	4.2 / 4.7 / 5.2mm	1.0 mm, 1.5 mm, 2.0mm, 3.0 mm, 4.0 mm,5.0 mm, 7.0 mm

6.2.9. Direct Healing Abutment

	Candidate:	Reference Device:
Company	Medical Instinct Deutschland GmbH	Nobel Biocare USA LLC	Discussion
DeviceName	BoneTrust® Direct Healing Abutments	Healing Cap Multi-Unit Titanium	--
510(K)number	--	K171142	--
Maximumintraoral use	180 Days	180 Days	Identical
Load	Non-occlusal loading	Non-occlusal loading	Identical
Material	Titanium alloy TiAl4V	Titanium alloy Ti6Al4V ELI(ASTM F136)	Identical
Surface	anodized surface	anodized surface	Identical
Connection	Cylindrical external Hexagon or and conicaltorx	Conical fitting	Results of dynamicfatigue testing supportthat differences ininner geometry do notraise any concerns inregard to safety andeffectiveness of theimplant - abutmentinterface
Size	Healing Cap Height: 4.75 mmHealing Cap Diameter 4.9 mm	Healing Cap Height: 4.1 and 5.5 mmHealing Cap Diameter 5.0, 6.0, 6.9 mm	Sizes are within rangeof K171142, exceptHealing Cap Diameteris 0.1 mm smaller.This difference is dueto the specific fitting tothe abutment anddoes not raise anyconcerns in regard tosafety and effective-ness of the proposeddevices
CompatibleAbutments	Bone Trust® Direct Abutments	Nobel Biocare Multi Unit Abutments	Adapted to fit manu-facturer's abutmentsystem

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m

Company	Candidate:		Reference Device:	Discussion
	Medical Instinct Deutschland GmbH		Straumann USA
DeviceName	BoneTrust® Healing Abutments Wide Body		Healing Abutment	--
510(K)number	--		K130808	--
Maximumintraoral use	180 Days		180 Days	Identical
Load	Non-occlusal loading		Non-occlusal loading	Identical
Material	Titanium alloy TiAl4V		Titanium alloy Ti6Al4V ELI(ASTM F136)	Identical
Surface	anodized surface		anodized surface	Identical
Connection	Cylindrical external Hexagon or and conicaltorx		Conical fitting	Results of dynamicfatigue testing supportthat differences ininner geometry do notraise any concerns inregard to safety andeffectiveness of theimplant - abutmentinterface
Size	Platform Diameter	Gingival Height(GH)	Plattform Diameters: 3.3mm, 3.5mm,4.1mm, 4.8mm, 6.5mmGingival Heights:2.0mm, 3.5mm, 4.0mm, 5.0mm, 6.0 mm	Within range of refer-ence device
	3.4 mm / 4.0 mm	3.0 mm, 5.0 mm
	5.0 mm	3.0 mm, 5.0 mm

6.2.10. Healing Abutment Wide Body

7. Performance testing

7.1. Summary of Clinical Testing

No clinical studies were performed for the BoneTrust® Implant System

7.2. Summary of non-Clinical Testing

The following nonclinical testing data were provided or relied upon in support of the substantial equivalence determination.

7.2.1. Biocompatibility

Biocompatibility assessment has been performed according to ISO 10993 series and included testing for cytotoxicity according to ISO 10993-5.

Results support substantial equivalence of the BoneTrust® implants to legally marketed predicate devices.

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7.2.2. Fatigue testing

Fatigue testing of the implant-abutment interface has been tested for representative samples in accordance with ISO 14801.

Results support substantial equivalence of the BoneTrust® implants to legally marketed predicate devices.

7.2.3. Sterilization

Validation of sterilization instructions for non-sterile devices have been conducted according to ISO 17665-1 and ISO 17665-2 for pre-vacuum steam sterilization (wrapped cycle) demonstrating a sterility assurance level (SAL) of 10-6.

Sterilization validation for device delivered sterile has been conducted according to ISO 11137-1 and 11137-2 for Beta-radiation sterilization. Shelf life testing has been conducted according to ISO 11607-1 and ASTM F1980 under consideration of accelerated and real-time ageing conditions. LAL testing was conducted according to USP 85 and the FDA Guidance "Submission and Review of Sterility information in Premarket Notification 510k Submissions for Devices Labeled as Sterile."

7.2.4. Implant Surface Analysis

Investigation of the implant surface included Energy Dispersive X-ray Spectroscopy (EDX), SEM (Scanning Electron Microscopy) and BSE (Back-Scattered-Electrons / secondary electrons analysis. Results support substantial equivalence of the BoneTrust® implants to legally marketed predicate devices.

Non-clinical Performance Data BoneTrust® Short Implants 7.2.5.

In order to verify substantial equivalence to already marketed devices. BoneTrust® short implants were subjected to the following non-clinical performance studies:

. Comparative Surface area analysis
. Comparative Bone-to-implant contact study using animal histology
. Comparative pull-out strength test

Results support substantial equivalence of the BoneTrust® short implants to legally marketed predicate devices.

Conclusion as to Substantial Equivalence 8.

Based on the comparison of the indications for use, the technological characteristics and the nonclinical testing it can be concluded that the BoneTrust® Implant System is substantially equivalent to the predicate 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.