The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively prith MyPlason and and prosthetic components. The abutments serve for prosthetic restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In castof oppriate primary stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be appriverad.

Device Description

The MyPlant II implant system serves as a tooth root substitute and can be used in free jaw sections or edentulous jaws. The MyPlant II implant is made of pure titanium Grade 4 (3.7065). The implant surface is micro-structured. The surface structure is created by blasting with white corundum (> 99 % AlsO3 = aluminum oxide) and etching with acid. Prosthetic connection and thus force transmission is conveyed via an internal cone. A sterile cover screw of 1 mm height is enclosed with each implant to enable an immediate occlusion of the internal thread after successful insertion. The implants are supplied sterile and are intended for single use. MyPlant II Implant System includes various implant variations with different diameters and lengths.

Dental abutments are used to support prosthetic reconstruction. Prosthetic applications can include individual crowns, bridges, partial or full prostheses. Abutments can be used for the replacement of one or more teeth. Depending on the indication and the anatomical conditions, the user will use several components for the specific prosthetic purpose. All components are made of a material suitable for the purpose of the application. The abutments are made of pure titanium Grade 4 (3.7065), titanium alloy Grade 5-ELI (Grade 23/3.7165), or PEEK. Except for the PEEK healing caps, the abutment surface is anodized. Connection to the implant is assured via an internal tapered connection as well as a metric thread. In the case of Abutments 0° / 15° and Shoulder Abutments, the abutment screw is not anodized and undergoes laser welding to connect the threaded sleeves with the shaft. The subject abutments are listed in a table with article number, description, and specifications.

AI/ML Overview

The document provided is a 510(k) Premarket Notification from the FDA for the MyPlant II Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested details about acceptance criteria and study design are not explicitly available or applicable in the provided text. The document's purpose is to show that the new device is as safe and effective as a legally marketed one, not to independently prove its performance against a set of acceptance criteria in a quantitative sense with a large-scale clinical study that would yield metrics like sensitivity, specificity, or effect sizes for human readers.

However, I can extract information related to the non-clinical tests performed to demonstrate substantial equivalence, which can be seen as meeting certain underlying "acceptance criteria" for material, sterility, and mechanical performance.

Here's a breakdown based on the provided text:

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

The document does not present a table of explicit acceptance criteria and corresponding reported device performance in the manner typically seen for diagnostic algorithms (e.g., sensitivity, specificity, F-score). Instead, it lists performance tests and validations conducted against established standards to demonstrate the safety and effectiveness of the dental implant system. The "performance" is reported as conformance to these standards.

Acceptance Criteria (Standard Conformance)	Reported Device Performance (Conformance)
Gamma sterilization validation according to ISO 11137-1 and 11137-2	Conducted on the subject device and met the standards.
Steam sterilization validation according to ISO 17665 and ST79	Referenced from K132214 (predicate/reference device), implying the subject device meets these by equivalence.
Cleaning validation: LAL endotoxin test according to USP [85] and ANSI AAMI ST72	Referenced from K132214, implying the subject device meets these by equivalence.
Sterile barrier system validation according to ISO 11607, ASTM F88/F88M-15 and ASTM F1929-15	Conducted on the subject device and met the standards.
Biocompatibility assessment according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5	Proposed implants: referenced from K143539. Proposed abutments: conducted on the subject device. Both met the standards.
Fatigue testing according to ISO 14801 and FDA Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments	Conducted on the subject device and met the standards. Effect of design change (inner cone connection extension) evaluated by fatigue testing and FEM analysis.

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

This information is not applicable/not provided in the context of this 510(k) submission. The document reports on non-clinical (laboratory) tests and relies on equivalence to predicate devices, rather than a clinical study with a "test set" of patients or data in the way an AI/software device would. The "samples" referred to are physical device components for testing (e.g., for fatigue, sterilization).

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)

This is not applicable/not provided. The ground truth for the non-clinical tests (e.g., successful sterilization, lack of cytotoxicity, fatigue resistance) is established by adherence to recognized international and national standards and validated laboratory procedures, not by expert consensus on clinical cases.

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

This is not applicable/not provided. Adjudication methods are typically relevant for clinical studies that involve human interpretation or subjective assessment. The tests performed are objective, based on standardized protocols.

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

This is not applicable/not provided. The MyPlant II Implant System is a physical medical device (dental implants and abutments), not an AI/software device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers (e.g., dentists, radiologists) and AI assistance is not relevant or described in this document.

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

This is not applicable/not provided. The device is a physical dental implant system, not a standalone algorithm.

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

The "ground truth" for the non-clinical tests is established by technical standards and validated laboratory methods. For example:

Sterilization: Demonstrated sterility to a specified sterility assurance level (SAL).
Biocompatibility: Absence of toxic effects as per ISO 10993.
Fatigue: Resistance to fracture or failure under specified cyclic loading as per ISO 14801.

8. The sample size for the training set

This is not applicable/not provided. This document pertains to a physical medical device. The concept of a "training set" is relevant for AI/machine learning models, which are not the subject of this 510(k) submission.

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

This is not applicable/not provided for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 9, 2018

Hager & Meisinger GmbH Adam Tomczak Regulatory Affairs Hansemannstrasse 10 Neuss, 41468 GERMANY

Re: K173819

Trade/Device Name: MyPlant II Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 2, 2018 Received: July 9, 2018

Dear Adam Tomczak:

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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173819

Device Name MyPlant II Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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1. Applicant's Name and Address:

Hager & Meisinger GmbH
Hansemannstrasse 10
41468 Neuss
Germany
Phone:	0049 2131 2012 293
Fax:	0049 2131 2012 223
Contact Person:	Dr. Adam Tomczak, Regulatory Affairs

2. Date prepared:

Date prepared:

9 August 2018

3. Name of the Device:

Trade Name:	MyPlant II Implant System
Common Name:	Dental Implants, Dental Implant Abutments
Classification Name:	Root-form Endosseous Dental Implants, Endosseus Dental ImplantAbutment Devices
Product Code:	DZE
Subsequent Product Code:	NHA
Regulation No:	872.3640
Class:	II
Panel:	Dental

4. Primary Predicate Device:

510(k) No.	Manufacturer	Trade Name
K143539	Hager & Meisinger GmbH.	Dental Implant System OKTAGON® Bone Level

Reference Devices:

510(k) No.	Manufacturer	Trade Name
K083805	Dentsply International, Inc	ANKYLOS® C/X Dental Implant System
K132214	Hager & Meisinger GmbH	Dental Implant Abutment OKTAGON®
K172505	MIS Implants Technologies Ltd	MIS C1 Narrow Platform Conical ConnectionImplant System MIS C1 Wide Platform Conical

Connection Abutments

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5. Device Description:

Implants

Article No.	Diameter [mm]	Length [mm]
A3580	3.5	8.0
A3595	3.5	9.5
A3511	3.5	11.0
A3514	3.5	14.0
M4080	4.0	8.0
M4095	4.0	9.5
M4011	4.0	11.0
M4014	4.0	14.0
B4580	4.5	8.0
B4595	4.5	9.5
B4511	4.5	11.0
B4514	4.5	14.0

Abutments

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connection as well as a metric thread. In the case of Abutments 0° / 15° and Shoulder Abutments, the abutment screw is not anodized and undergoes laser welding to connect the threaded sleeves with the shaft. The subject abutments are listed in the table below.

Article No.	Description	Specifications [mm]
		GH=gingiva height, H=height, L=length
PAB01	Abutment 0°	GH 1.5 H 4.0
PAB02	Abutment 0°	GH 1.5 H 6.0
PAB03	Abutment 0°	GH 3.0 H 4.0
PAB04	Abutment 0°	GH 3.0 H 6.0
PAB51	Abutment 15°	GH 1.5 H 4.0
PAB52	Abutment 15°	GH 1.5 H 6.0
PAB53	Abutment 15°	GH 3.0 H 4.0
PAB54	Abutment 15°	GH 3.0 H 6.0
PSA01	Shoulder Abutment 0°	GH 1.5 H 6.0
PSA02	Shoulder Abutment 0°	GH 3.0 H 6.0
PSA51	Shoulder Abutment 15°	GH 1.5 H 6.0
PSA52	Shoulder Abutment 15°	GH 3.0 H 6.0
PKA01	Ball Anchor	GH 1.5
PKA02	Ball Anchor	GH 3.0
PKA03	Ball Anchor	GH 4.5
PGF15	Healing Abutment	GH 1.5
PGF30	Healing Abutment	GH 3.0
PGF45	Healing Abutment	GH 4.5
PHK01	Healing Cap	H 4.0
PHK02	Healing Cap	H 6.0
PVS00	Cover Screw 0 mm	L 5.5
PVS01	Cover Screw 1 mm	L 6.5
Article No.	Description	Specifications [mm]GH=gingiva height, H=height, L=length
PVS02	Cover Screw 2 mm	L 7.5
POS01	Occlusal Screw	L 4.5
PSVK1	Screw for Ceramics	L 4.5

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6. Indications for Use:

The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively with MyPlant II abutments and prosthetic components. The abutments serve for prosthetic restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In case of appropriate primary stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be performed.

7. Basis for substantial equivalence

The tables below compare the Indications for Use Statements and the technological characteristics of the subject device system and the predicate/reference devices.

	Indications for Use Statement		MyPlant IIImplant System(subject device)	Dental ImplantSystemOKTAGON® BoneLevel (primarypredicate)	ANKYLOS® C/XDental ImplantSystem(reference device)	MIS C1 NarrowPlatform ConicalConnection ImplantSystem MIS C1 WidePlatform ConicalConnectionAbutments(reference device)
Subject Device		510(k) No.	K173819	K143539	K083805	K172505
K173819MyPlant II Implant System	The MyPlant II implants are surgically placed in the maxilla or mandible toenable prosthetic restorations in edentulous or partially edentulous patients.The implants are to be used exclusively with MyPlant II abutments andprosthetic components. The abutments serve for prosthetic restorations andcan include individual crowns, bridges, partial or full prostheses. Abutmentscan be used for single tooth restorations or for the restoration of severalteeth. The implants are intended for delayed loading with two surgicalinterventions. In case of appropriate primary stability (35 Ncm), immediatetemporary restoration with appropriate occlusal load can also be performed.	ImplantType	Bone-level	Bone-level	Bone-level	Bone-level
Primary Predicate		Material	Titanium Grade 4	Titanium Grade 4	Titanium Grade 2	Ti6Al4V Grade 5-EL
K143539Dental Implant System	The implants are surgically placed in the maxillary and/ or mandibulararches to provide support for prosthetic restorations in edentulous or	EndosseousSurface	Micro-structured(grit blasted andacid-etched)	Micro-structured(grit blasted and acid-etched)	Micro-structured(grit blasted andacid-etched)	Micro-structured(grit blasted andacid-etched)
OKTAGON® Bone Level	partially edentulous patients. The implants are intended to be used withOKTAGON® Bone Level abutments and prosthetic parts. Dental ImplantAbutments Bone Level are intended to provide support for prostheticreconstructions. Prosthetic applications can include individual crowns,bridges, partial or total prostheses. Abutments can be used in single toothreplacements and multiple tooth restorations. The Abutments are intendedto be compatible to OKTAGON® Bone Level implants with diameters3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and14mm. The Oktagon Bone Level System is intended for delayed loading,or for immediate loading when good primary stability is achieved andwith appropriate occlusal load.	ThreadDesign	Progressive	Consistent	Progressive	Progressive
Reference Devices		Implant-abutmentconnection	Tapered, withoutindexation	Octagonal	Tapered, availablewith and withoutindexation	Tapered, withindexation
K083805ANKYLOS® C/XDental Implant System	The ANKYLOS® C/X Implant System is for single-stage or two-stage surgicalprocedures and cemented or screw retained restorations. The ANKYLOS®C/X Implant System is intended for immediate placement and function onsingle tooth and/or multiple tooth applications when good primary stability isachieved, with appropriate occlusal loading, in order to restore chewingfunction. Multiple tooth applications may be splinted with a bar.	ImplantLength	8.0 / 9.5 / 11.0 /14.0 mm	8.0 / 10.0 / 12.0 /14.0 mm	8.0 / 9.5 / 11.0 /14.0 / 17.0 mm	10.0 / 11.5 / 13.0 /16.0 mm
K132214Dental Implant AbutmentOKTAGON®	Dental Implant Abutments are intended to provide support for prostheticreconstructions. Prosthetic applications can include individual crowns, bridges,partial or total prostheses.Abutments can be used in single tooth replacements and multiple toothrestorations.The Dental Implant Abutments OKTAGON® are intended to be compatibleto OKTAGON® implants (Dental Implant OKTAGON®) with diameters3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platformand Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm.
K172505MIS C1 Narrow PlatformConical Connection ImplantSystemMIS C1 Wide PlatformConical ConnectionAbutments	MIS dental implant system is intended to be surgically placed in the bone ofthe upper or lower jaw arches to provide support for prosthetic devices, suchas artificial teeth, in order to restore masticatory function. When a one-stagesurgical procedure is applied, the implant may be immediately loaded whengood primary stability is achieved and the occlusal load is appropriate.Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical andrestorative applications for placement only in the mandibular central, lateralincisor and maxillary lateral incisor regions of partially edentulous jaws, toprovide support for prosthetic devices such as artificial teeth, in order torestore the patient chewing function. Mandibular central and lateral incisorsmust be splinted if using two or more narrow implants adjacent to oneanother.

Comparison of Indications for Use Statements:

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The comparison of Indications for Use Statements shows that the subject device and the primary predicate have the same intended use. Both implant systems are surgically placed in the maxilla or the

{8}------------------------------------------------

mandible to provide support for single tooth or multiple tooth restorations. The surgical procedure may be two-stage or single-stage, with the possibility of immediate prosthetic restoration with appropriate occlusal load (in case of good primary stability). K143539 Indications for Use Statement additionally states that "The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm". This information about implant-abutment compatibility does not change the intended use. Further small differences in wording do not change the intended use.

Comparison of technological characteristics - implants:

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EndosseousDiameter	3.5 / 4.0 / 4.5 mm	3.3 / 4.1 / 4.8 mm	3.5 / 4.5 / 5.5 / 6.5 mm	3.3 mm
Sterility	Provided sterile;irradiation	Provided sterile;irradiation	Provided sterile;irradiation	Provided sterile;irradiation

As compared to the primary predicate K143539, the subject implants use the same materials and manufacturing methods. With regard to length and diameter, the subject implants lie within the range of the predicate device. The sterilization method is the same. However, the thread design and the implant-abutment connection are different. This gap is closed by K083805 implants, which have the same thread design and implant-abutment connection type (self-locking inner cone + retention screw). The main design difference between the subject device system and K083805 reference device is the extension of the inner cone connection which provides the implant-abutment interface. The effects of this design change have been evaluated by fatigue testing and FEM analysis, supporting substantial equivalence.

	MyPlant IIImplantSystem(subjectdevice)	Dental ImplantSystemOKTAGON®(primarypredicate)	ANKYLOS®C/X DentalImplant System(referencedevice)	Dental ImplantAbutmentOKTAGON®(referencedevice)	MIS C1 NarrowPlatform ConicalConnectionImplant SystemMIS C1 WidePlatform ConicalConnectionAbutments(reference device)
510(k) No.	K173819	K143539	K083805	K132214	K172505
Material	Ti6Al4VGr.5 - ELITitanium Gr. 4PEEK	Ti6Al4VGr.5 - ELITitanium Gr. 4POM-C	Ti6Al4VPOM	Ti6Al4VGr.5 – ELITitanium Gr. 4POM-C	Ti6Al4V - ELIPEEKPOMGold alloy
Angulation	0° / 15°	0°	0° - 22.5°	0° - 20°	0° - 30°
Implant-abutmentconnection	Tapered,withoutindexation	Octagonal	Tapered,available withand withoutindexation	Octagonal	Tapered, withindexation
Sterility	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile

Comparison of technological characteristics abutments:

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The subject abutments are intended to enable various single-tooth and multiple tooth restorations. With respect to the predicate, the main differences are the angulation (the predicate does not include angled abutments), and the implant-abutment connection. This gap is bridged by K083805 abutments, which are very similar to the subject abutments in terms of design. Below the intended use and the technological characteristics have been compared with predicate/reference device for each abutment type included in this submission, and the most similar predicate/reference abutment has been identified. Regarding indexation of the implant-abutment connection, the reference device K083805 allows the user to choose between indexed (/X) and unindexed connection (/C). The subject device system will be made available without indexation, so substantial equivalence to the /C variation is claimed.

	MyPlant IIImplant System(subject device)	ANKYLOS® C/XImplant System(reference device)	ANKYLOS® C/XImplant System(reference device)
K Number	K173819	K083805	K083805
Product Name	Abutments 0° / 15°	Standard C/Abutments	SynCone C/ Abutments
Intended Use	Support screw-retainedrestorations oroverdentures onprefabricated taper caps	Support cemented or screw-retained restorations	Support overdentures onprefabricated taper caps
Material	Ti6Al4V Gr.5 - ELI	Ti6Al4V	Ti6Al4V
Diameter	3.5 mm	3.3 / 4.5 mm	4.0 mm
Gingiva height	1.5 / 3.0 mm	1.5 / 3.0 / 4.5 / 6.0 mm	1.5 / 3.0 / 4.5 mm
Post height	4.0 / 6.0 mm	4.0 / 6.0 mm	4.0 mm
Angulation	0° / 15°	0°/ 15°	0° / 15° / 22.5°
Connection toimplant	Tapered + metric thread,without indexation	Tapered + metric thread,without indexation	Tapered + metric thread,without indexation
Sterility	Non-sterile	Non-sterile	Non-sterile

Abutments 0° / 15° (PAB01-04, PAB52-54)

The subject abutments are substantially equivalent to the reference device in all features. There is a small difference in the abutment diameter, but the subject device lies within the range of the predicate. The SynCone C/ Abutment has been included in the comparison because, as in the case of

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the subject abutment, the abutment body is tapered to enable prosthetic restoration with overdentures on taper caps (this form of restoration is not possible on K083805 Standard C/ abutment).

Shoulder Abutments (PSA01-02, PSA51-52)

	MyPlant II Implant System(subject device)	ANKYLOS® C/X Implant System(reference device)
K Number	K173819	K083805
Product Name	Shoulder abutments	Regular C/Abutments
Intended Use	Support cemented or screw-retained restorations	Support cemented or screw-retained restorations
Material	Ti6Al4V Gr.5 - ELI	Ti6Al4V
Diameter	5.0 mm	5.7 mm
Gingiva height	1.5 / 3.0 mm	0.75 / 1.5 / 3.0 / 4.5 mm
Post height	6.0 mm	6.6 / 7.0mm
Angulation	0°/15°	0° / 15° / 22.5°
Connection to implant	Tapered + metric thread,without indexation	Tapered + metric thread, withoutindexation
Sterility	Non-sterile	Non-sterile

The subject shoulder abutments are substantially equivalent to the reference device in all features despite small differences in dimensions. In the subject device, the post height is shorter, and the abutment diameter is slightly narrower. However, these differences do not represent a new worstcase within this submission.

Ball Anchors (PKA01-03)

	MyPlant IIImplant System(subject device)	ANKYLOS® C/XImplant System(reference device)	Dental Implant AbutmentOKTAGON®(reference device)
K Number	K173819	K083805	K132214

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Product Name	Ball Anchor	Snap Attachment C/	Retentive Anchor
Intended Use	Support retentively-fixatedoverdentures	Support retentively-fixatedoverdentures	Support retentively-fixatedoverdentures
Material	Titanium Grade 4	Ti6Al4V	Titanium Grade 4
Diameter (snapattachmentsphere)	2.25 mm	2.7 mm	2.25 mm
Gingiva height	1.5 / 3.0 /4.5 mm	1.5 / 3.0 /4.5 mm	Non-applicable (to be usedwith a tissue-level implant)
Height	3.5 mm	3.5 mm	3.4 mm
Angulation	Straight	Straight	Straight
Connection toimplant	Tapered + metric thread,without indexation	Tapered + metric thread,without indexation	Octagonal
Sterility	Non-sterile	Non-sterile	Non-sterile

The subject ball anchors are substantially equivalent to the reference devices in almost all features. In the subject device the snap sphere is narrower. This gap is closed by the reference device K132214, which uses an attachment sphere of the same size.

Healing abutments (PGF15, PGF30, PGF45)

	MyPlant II Implant System(subject device)	ANKYLOS® C/X ImplantSystem (reference device)
K Number	K173819	K083805
Product Name	Healing abutment	Standard C/ Sulcus Former
Intended Use	Closing the implant and shaping ofthe peri-implant soft tissue duringtransgingival healing	Closing the implant and shaping ofthe peri-implant soft tissue duringtransgingival healing
Material	Titanium Grade 4	Ti6Al4V
Diameter	Compatible with planned abutmentof 3.5 mm diameter	Compatible with planned abutmentof 3.3 / 4.5 mm diameter

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Height	Non-applicable	Non-applicable
Gingiva height	1.5 / 3.0 / 4.5 mm	1.5 / 3.0 / 4.5 / 6.0 mm
Angulation	Straight	Straight
Connection to implant	Tapered + metric thread, without indexation	Tapered + metric thread, without indexation
Sterility	Non-sterile	Non-sterile

The subject healing abutments are substantially equivalent to the reference device in all features. There is a minimal difference in the planned abutment diameter, but the subject device lies within the range of the predicate.

Healing caps (PHK01-02)

	MyPlant II Implant System(subject device)	ANKYLOS® C/XImplant System(reference device)	MIS C1 Narrow PlatformConical ConnectionImplant System MIS C1Wide Platform ConicalConnection Abutments(reference device)
K Number	K173819	K080385	K172505
Product Name	Healing Caps	Standard Temporary Cap	Plastic Healing Caps
Intended Use	Cover the abutment andprovide interface fortemporary restoration	Cover the abutment andprovide interface fortemporary restoration	Cover the abutment untilpermanent restoration isready
Material	PEEK	POM	PEEK
Diameter	3.5 mm	3.3 / 4.5 mm	No public data available
Height	4.0 / 6.0 mm	4.0 / 6.0 mm	4.0 / 6.0 / 8.0 mm
Gingiva height	-	-	-
Angulation	-	-	-
Connection toImplant	Non-applicable (the healingcap is mounted on the	Non-applicable (the healingcap is mounted on the	Non-applicable (the healingcap is mounted on the

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	abutment)	abutment)	abutment)
Sterility	Non-sterile	Non-sterile	Non-sterile

The subject healing caps are substantially equivalent to the reference devices in almost all features. The subject device uses a different material. This gap is closed by the reference device K172505, which includes a healing cap made of the same material.

Cover Screws (PVS00-02)

	MyPlant II Implant System(subject device)	ANKYLOS® C/X ImplantSystem (reference device)
K Number	K173819	K083805
Product Name	Cover Screw	C/X Cover Screw
Intended Use	Closing the implant duringsubgingival healing	Closing the implant duringsubgingival healing
Material	Titanium Grade 4	Ti6Al4V
Diameter	2.7 / 3.0 / 3.5 mm	2.5 - 3.5 mm
Height(above implant shoulder)	0.0 / 1.0 / 2.0 mm	0.0 / 1.0 / 2.0 mm
Gingiva height	Non-applicable	Non-applicable
Angulation	Non-applicable	Non-applicable
Connection to implant	Tapered + metric thread, withoutindexation	Tapered + metric thread, withoutindexation
Sterility	Sterile when delivered in theimplant package; Non-sterile asspare part	Sterile when delivered in theimplant package; Non-sterile asspare part

The subject cover screws are substantially equivalent to the reference device in all features.

Occlusal Screw (POS01), Screw for Ceramics (PVSK01)

	MyPlant II Implant System	ANKYLOS® C/X Implant

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	(subject device)	System (reference device)
K Number	K173819	K083805
Product Name	Occlusal Screw, Screw forCeramics	Fixation screw
Intended Use	Fixation of screw-retainedrestorations	Fixation of screw-retainedrestorations
Material	Ti6Al4V Gr. 5 -ELI	Ti6Al4V
Thread acc. to ISO 1502	M2	M1.4 / M1.6
Height	Non-applicable	Non-applicable
Gingiva height	Non-applicable	Non-applicable
Angulation	Non-applicable	Non-applicable
Connection to implant	Non-applicable	Non-applicable
Sterility	Non-sterile	Non-sterile

The subject screws for screw-retained restorations are substantially equivalent to the reference device in all features. There is a small difference in the thread size, but using a slightly larger thread for screw-retained restorations does not raise new performance or safety issues.

In summary, the above comparison shows that the subject abutments are substantially equivalent to the legally marketed predicate/reference devices. The intended use is identical, the used materials are the same or very similar, and the design parameters fall into the range of predicate/reference devices. Except for the healing caps made of PEEK, the manufacturing methods are shared with the predicate device K143539, albeit with a difference in the manufacturing process of the abutment screw used for Abutments 0° / 15° (PAB01-04, PAB52-54) and Shoulder Abutments (PSA01-02, PSA51-52). K143539 screws are manufactured as one part and are anodized, whereas the proposed screws use laser welding to connect the threaded sleeve with the shaft and are not anodized.

8. Performance tests and used standards

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include:

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· Gamma sterilization validation according to ISO 11137-1 and 11137-2 (conducted on the subject device).

· Steam sterilization validation according to ISO 17665 and ST79 (referenced from K132214).

· Cleaning validation: LAL endotoxin test according to USP [85] and ANSI AAMI ST72 (referenced from K132214).

• Sterile barrier system validation according to ISO 11607, ASTM F88/F88M-15 and ASTM F1929-15 (conducted on the subject device).

• Biocompatibility assessment according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 (proposed implants: referenced from K143539, proposed abutments: conducted on the subject device).

· Fatigue testing according to ISO 14801 and FDA Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments (conducted on the subject device).

No animal testing or human clinical trials have been conducted.

9. Conclusion

The subject device and the legally marketed predicate device have identical intended use. The technological characteristics are the same or very similar, as shown by the predicate/reference device comparison. Based on the assessment of applicable performance data, the subject device system does not raise new performance or safety issues. Thus, we concluded that the subject device is substantially equivalent to the legally marketed predicate device listed above.

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.