Predicate Devices

Reference Devices

K090716, K161435, K102436, K161416, K072878

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a system of dental implants, healing posts, and abutments made of titanium. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on material properties, biocompatibility, mechanical testing, and sterilization, which are standard for this type of device.

Therapeutic

Yes.
The device is an implant system used for dental restorations to provide prosthetic rehabilitation, which directly treats a medical condition (missing teeth) and restores function.

Diagnostic

No
The device, BEGO Semados® RS/RSX Implant System, is composed of implants, healing posts, and abutments used for dental restorations. Its intended use is for surgical implantation and prosthetic rehabilitation, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components such as implants, healing posts, and abutments made of titanium. There is no mention of software as a component of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device as being used for dental restorations (implants, healing posts, and abutments) within the human body (upper and lower jaw). This is a therapeutic and prosthetic application, not a diagnostic one.
Device Description: The description details physical components made of titanium that are surgically implanted or attached to implants. This aligns with a medical device used for treatment or restoration, not for analyzing samples from the body to diagnose a condition.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

Therefore, the BEGO Semados® RS/RSX Implant System is a medical device, specifically a dental implant system, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BEGO Semados® RS/RSX Implant System consists of implants, healing posts and abutments.

The BEGO Semados® RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading on sufficient primary stability and appropriate occlusal loading.

The BEGO Semados® RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors.

The healing posts are indicated for patients treated with BEGO Semados® RS/RSX implants for the time during healing of the surrounding soft tissue.

The abutments are indicated for patients treated with BEGO Semados® RS/RSX implants as an aid in prosthetic rehabilitation.

PS ITA, PS TTiA and PS TTiA NH are intended to be used for a maximum period of 6 months.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

BEGO Semados® RS/RSX implants (DZE - 872.3640 – Class II) are dental implants which are made for subgingival placement in both, the upper and lower jaw, using one- or two-stage surgical procedures. They are used to replace lost teeth and to attach prosthetic restorations.

BEGO Semados® RS/RSX implants are self-tapping, conical endosseous dental implants made of commercially pure titanium Grade 4 (ISO 5832-2 and ASTM F-67 compliant). In contrast to the RSX implant family, the RS implant family has a 0.5 mm machined neck region.

BEGO Semados® RS/RSX implants are marketed together with cover screws and insertion posts. BEGO Semados® Implant Cover Screws are intended for implant-abutment interface closure for submerged healing of the dental implant during a two stage surgical procedure. The insertion posts are used together with a ratchet or hand-piece to insert the implant.

Healing posts: The healing posts are sterile packaged Titanium Grade 5 (Ti6Al4V) (ISO 5832-3 and ASTM F-136 compliant) dental healing abutments that are available in two different sizes. Healing posts can be used either to shape the soft tissue after sub-merged healing of an implant (two-stage) or to keep the shape of the soft tissue after having placed the implant (one-stage). The sizes are according to the sizes of the compatible BEGO Semados® implant. The following devices are included:
a) PS HP (Healing post Platform Switch);
b) PS HPW (Healing post wide body Platform Switch).

Abutments: The abutments are prefabricated prosthetic components made of Titanium Grade 5 (Ti6Al4V) (ISO 5832-3 and ASTM F-136 compliant) directly connected to BEGO Semados® implants with Platform Switch design such as BEGO Semados® RS/RSX implants. They are delivered non-sterile but have to be sterilized by the end-user They serve as an aid in temporary (provisional) and permanent prosthetic rehabilitation. The abutments are used for single or multiple tooth restorations. They are available in diameters compatible to the BEGO Semados® implant diameters (3.0-5.5mm). There are two types of abutments regarding the duration of use: provisional abutments intended for a limited period of ≤ six months and permanent abutments.

The abutments are marketed with the compatible prosthesis and a technician screw, which are identical in material composition, design and manufacturing process. The prosthesis screw is used to connect the abutment to the BEGO Semados® RS/RSX implant. The technician screw is used by the dental technician when making the prosthetic restoration.

For temporary (provisional) prosthetic restorations the following provisional abutments (temporary use, ≤ six months) are available:
a) PS TTiA (Provisional abutment Platform Switch);
b) PS TTiA NH (Provisional abutment Platform Switch);
c) PS ITA (Provisional abutment Platform Switch).

For permanent prosthetic restorations the following abutments are available:
a) PS TiA (Solid abutment titanium Platform Switch);
b) PS TiAA (Solid abutment titanium Platform Switch).

MultiPlus system: The MultiPlus system consists of the PS MultiPlus abutments, the MultiPlus Titanium abutment, the MultiPlus Healing posts, the MULTI PLUS UNIVERSAL component and various supporting tools like e.g. positioning aids.

The MultiPlus system is intended for occlusal screw-retained bridge, full dentures and bar constructions in the mandible and maxilla.

a) PS MultiPlus abutments: The PS MultiPlus abutments are made of Titanium Grade 5 (Ti6A4V) (ISO 5832-3 and ASTM F-136 compliant) and are screwed directly into the RS/RSX implants. They are available in two different gingiva heights (GH 1 mm and 3 mm) and in three different angulations (0°, 20° and 30°). PS MultiPlus abutments are delivered sterile with MultiPlus positioning aid and prosthesis screw (20° and 30°).

b) MultiPlus Titanium abutment: The MultiPlus Titanium abutment is used for creating temporary and definitive constructions and is screwed onto the PS MultiPlus abutment (0°, 20° or 30°). The MultiPlus Titanium abutment is made of Titanium Grade 5 (Ti6Al4V) (ISO 5832-3 and ASTM F-136 compliant) and delivered sterile together with a prosthetic screw and a technician screw also made of Titanium Grade 5.

c) MULTI PLUS UNIVERSAL: MULTI PLUS UNIVERSAL is an abutment made of Polyoxomethylene (POM) which can be used for temporary and definitive constructions. It is casted by the technician with an alloy. MULTI PLUS UNIVERSAL is screwed onto the PS MultiPlus abutment (0°, 20° or 30°). It is delivered non-sterile together with a prosthetic and a technician screw made of Titanium alloy grade 5 (ISO 5832-3 and ASTM F-136 compliant).

d) MultiPlus Healing posts: MultiPlus Healing posts are used for shaping the soft tissue after the osseointegration. They are made of Titanium grade 5 (ISO 5832-3 and ASTM F-136 compliant). MultiPlus Healing posts are delivered sterile.

Easy-Con System: The Easy-Con system consists of the PS Easy-Con abutment and the Easy-Con laboratory set.

a) PS Easy-Con abutments: PS Easy-Con abutments are prefabricated abutments which are used to retain full supported dentures in the mandible or maxilla on two to four implants. The PS Easy-Con abutment is made of Ti-6Al-4V grade 5, according to ASTM F136 and coated with titanium nitride. It is delivered non-sterile.

b) Easy-Con laboratory set: The Easy-Con laboratory set consists of two Easy-Con retention caps which are made of Titanium alloy Ti-6Al-4V grade 5, according to ASTM F136 and two Easy-Con block-out rings which are made of Silicone. Furthermore the set contains two Easy-Con production inserts (black) and two sets of Easy-Con retention inserts (transparent, pink and blue).

c) Easy-Con retention inserts: The Easy-Con retention inserts are prefabricated components that are used exclusively in conjunction with the Easy-Con retention cap for prosthesis anchorage. The different colored retention inserts differ in the withdrawal force and the possible divergence compensation inserts are made of nylon.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper and lower jaw

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance data was provided.
Specific tests included:

Materials were qualified according to ISO 5832-2:2018-03, ISO 5832-3:2016-10, ASTM F136-13 and ASTM F67-17 for Titanium Grade 4 and Titanium Grade 5 Material Specifications.
Biocompatibility testing for contacting materials: cytotoxicity (ISO 10993-5:2009-06), sensitization reactivity (ISO 10993-10:2010-08), and genotoxicity (ISO 10993-3:2014-10).
Bacterial endotoxin testing per USP 42-NF37 .
Functional and mechanical properties: Static and dynamic fatigue tests on implants with abutments (ISO 14801:2007-11, ISO 14801:2016-11, and FDA guidance on Root-form Endosseous Dental Implants).
Energy disperse X-ray spectroscopy (EDX-analysis) and roughness test on implant surface (ISO 4287:1997-04 and ISO 4288:1996-08).
Static immersion and open circuit potential measurements for corrosion resistance (ISO 10271:2001-06).
Sterilization testing for gamma-sterilized devices (ISO 11137-2:2013-06, ISO 11737-1:2018-01, ISO 11737-2:2009-11). A sterility assurance level (SAL) of 10^-6 was validated.
Sterilization validation for end-user sterilized non-sterile devices (ISO 17665-1:2006-08 and FDA guidance).
Shelf life and transport packaging testing (ISO 11607-1:2019-02, ISO 11607-2:2019-02, ASTM F88/F88M-09, ASTM F1886/F1886M-09, ASTM F1980-11, ASTM F1929-12, ASTM F2096-11, EN 868-5:2009, ISTA 2A:2011).
Usability engineering testing per IEC 62366-1:2015-02.
Risk management per ISO 14971:2007-03.
MR Safety investigation for implants and abutments: Displacement force test (ASTM F2052-15), Torque test (ASTM F2213-06 (2011)), RF heating test (ASTM F2182-11a), MR image artefacts test (ASTM F2119-07 (2013)). Demonstrated that devices are MR Conditional.

No human clinical testing was required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142260, K090716

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K090716, K161435, K102436, K161416, K072878

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

BEGO Implant Systems GmbH & Co. KG Bertrand Lecointe Regulatory Affairs Manager Wilhelm-Herbst-Str. 1 Bremen, Bremen 28359 GERMANY

Re: K201700

Trade/Device Name: BEGO Semados® RS/RSX Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 11, 2020 Received: December 14, 2020

Dear Bertrand Lecointe:

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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K201700

Device Name BEGO Semados® RS/RSX Implant System

Indications for Use (Describe) The BEGO Semados® RS/RSX Implant System consists of implants, healing posts and abutments.

The BEGO Semados® RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading on sufficient primary stability and appropriate occlusal loading.

The BEGO Semados® RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors.

The healing posts are indicated for patients treated with BEGO Semados® RS/RSX implants for the time during healing of the surrounding soft tissue.

The abutments are indicated for patients treated with BEGO Semados® RS/RSX implants as an aid in prosthetic rehabilitation.

PS ITA, PS TTiA and PS TTiA NH are intended to be used for a maximum period of 6 months.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

3

510(k) Summary

Device Name: BEGO Semados® RS/RSX Implant System

1. Submitter information

BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 28359 Bremen, Germany Phone: +49 (0) 421 2028-246 Fax: +49 (0) 421 2028-265 Establishment Registration Number: 3008252251 Owner/Operator Number: 10028/893

2. Official Correspondent

Kathleen Al-Kaissy, Regulatory Affairs Manager BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 28359 Bremen, Germany Phone: +49 (0) 421 2028-338 E-Mail: IM-RA@bego.com

3. Application Correspondent

Bertrand Lecointe, Regulatory Affairs Manager BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 28359 Bremen, Germany Phone: +49 (0) 421 2028-230 E-Mail: IM-RA@bego.com

4. US Agent (contact)

Frederick J. Horstkotte BEGO USA, Inc. 24 Albion Road Suite No. 103 Lincoln, RI 02865 Phone: 800 3422346 Ext Fax: 401 3349265 E-Mail: Fred@bego.com

5. Date prepared

1/13/2021

4

6. Device identification

Trade/Proprietary name:	BEGO Semados® RS/RSX Implant System
Classification name:	Endosseous dental implant (21 CFR 872.3640)
Endosseous dental implant abutment (21 CFR 872.3630)
Primary product code:	DZE
Secondary product code:	NHA
Device class:	Class II
Classification panel:	Dental

7. Legally marketed predicate devices

Table 5A – List of devices chosen from the primary predicate devices

| 510(k) number of primary predicate device: K142260

Device name: NobelActive
Trade name of the subject device	Trade name of the primary predicate device	Manufacturer
BEGO Semados® RS/RSX implants	NobelActive®	Nobel Biocare AB, SWEDEN
510(k) number of primary predicate device: K090716
Device name: BEGO Semados® S-Line
Trade name of the subject device	Trade name of the primary predicate device	Manufacturer
PS HP and PS HPW	Healing posts	BEGO Implant Systems GmbH & Co. KG, GERMANY
PS TiA and PS TiAA	Sub-Tec Titanium abutment anatomical
510(k) number of reference predicate device: K090716
Device name: BEGO Semados® S-Line
Trade name of the subject device	Trade name of the reference predicate device	Manufacturer
BEGO Semados® RS/RSX implants	BEGO Semados® S implant	BEGO Implant Systems GmbH & Co.
KG, GERMANY
510(k) number of reference predicate device: K161435
Device name: Temporary Snap Abutment
Trade name of the subject device	Trade name of the reference predicate device	Manufacturer
PS TTiA and PS TTiA NH	Temporary Snap Abutment	Nobel Biocare AB, SWEDEN
510(k) number of reference predicate device: K102436
Device name: NobelActive 3.0
Trade name of the subject device	Trade name of the reference predicate device	Manufacturer
PS HP and PS HPW	Healing Abutments	Nobel Biocare AB, SWEDEN
PS ITA	Immediate Temporary Abutment
PS TiA and PS TIAA	Esthetic Abutments and 15° Esthetic Abutment
510(k) number of reference predicate device: K161416
Device name: Multi-unit Abutment Plus
Trade name of the subject device	Trade name of the reference predicate device	Manufacturer
MultiPlus system	Multi-unit Abutment Plus	Nobel Biocare AB, SWEDEN
510(k) number of reference predicate device: K072878
Device name: Modification To Locator Implant Anchor
Trade name of the subject device	Trade name of the reference predicate device	Manufacturer
Easy-Con system	Locator® Implant Anchor Abutment
for Endosseous Dental Implant	ZEST Anchors Inc., USA

5

Table 5B – List of devices chosen from the reference predicate devices

6

8. Device description

RS/RSX implants

BEGO Semados® RS/RSX implants (DZE - 872.3640 – Class II) are dental implants which are made for subgingival placement in both, the upper and lower jaw, using one- or two-stage surgical procedures. They are used to replace lost teeth and to attach prosthetic restorations.

BEGO Semados® RS/RSX implants are self-tapping, conical endosseous dental implants made of commercially pure titanium Grade 4 (ISO 5832-2 and ASTM F-67 compliant). In contrast to the RSX implant family, the RS implant family has a 0.5 mm machined neck region.

BEGO Semados® RS/RSX implants are marketed together with cover screws and insertion posts. BEGO Semados® Implant Cover Screws are intended for implant-abutment interface closure for submerged healing of the dental implant during a two stage surgical procedure. The insertion posts are used together with a ratchet or hand-piece to insert the implant.

Healing posts

The healing posts are sterile packaged Titanium Grade 5 (Ti6Al4V) (ISO 5832-3 and ASTM F-136 compliant) dental healing abutments that are available in two different sizes. Healing posts can be used either to shape the soft tissue after sub-merged healing of an implant (two-stage) or to keep the shape of the soft tissue after having placed the implant (one-stage). The sizes are according to the sizes of the compatible BEGO Semados® implant. The following devices are included:

a) PS HP (Healing post Platform Switch);
b) PS HPW (Healing post wide body Platform Switch).

Abutments

The abutments are prefabricated prosthetic components made of Titanium Grade 5 (Ti6Al4V) (ISO 5832-3 and ASTM F-136 compliant) directly connected to BEGO Semados® implants with Platform Switch design such as BEGO Semados® RS/RSX implants. They are delivered non-sterile but have to be sterilized by the end-user They serve as an aid in temporary (provisional) and permanent prosthetic rehabilitation. The abutments are used for single or multiple tooth restorations. They are available in diameters compatible to the BEGO Semados® implant diameters (3.0-5.5mm). There are two types of abutments regarding the duration of use: provisional abutments intended for a limited period of ≤ six months and permanent abutments.

The abutments are marketed with the compatible prosthesis and a technician screw, which are identical in material composition, design and manufacturing process. The prosthesis screw is used to connect the abutment to the BEGO Semados® RS/RSX implant. The technician screw is used by the dental technician when making the prosthetic restoration.

7

For temporary (provisional) prosthetic restorations the following provisional abutments (temporary use, ≤ six months) are available:

a) PS TTiA (Provisional abutment Platform Switch);
b) PS TTiA NH (Provisional abutment Platform Switch);
c) PS ITA (Provisional abutment Platform Switch).

For permanent prosthetic restorations the following abutments are available:

a) PS TiA (Solid abutment titanium Platform Switch);
b) PS TiAA (Solid abutment titanium Platform Switch).

MultiPlus system

The MultiPlus system consists of the PS MultiPlus abutments, the MultiPlus Titanium abutment, the MultiPlus Healing posts, the MULTI PLUS UNIVERSAL component and various supporting tools like e.g. positioning aids.

The Multifles system is intended for occlusal screw-retained bridge, full dentures and bar constructions in the mandible and maxilla.

a) PS MultiPlus abutments

The PS MultiPlus abutments are made of Titanium Grade 5 (Ti6A4V) (ISO 5832-3 and ASTM F-136 compliant) and are screwed directly into the RS/RSX implants. They are available in two different gingiva heights (GH 1 mm and 3 mm) and in three different angulations (0°, 20° and 30°). PS MultiPlus abutments are delivered sterile with Multir® positioning aid and prosthesis screw (20° and 30°).

b) MultiPlus Titanium abutment
The MultiPlus Titanium abutment is used for creating temporary and definitive constructions and is screwed onto the PS MultiPlus abutment (0°, 20° or 30°). The MultiPlus Titanium abutment is made of Titanium Grade 5 (Ti6Al4V) (ISO 5832-3 and ASTM F-136 compliant) and delivered sterile together with a prosthetic screw and a technician screw also made of Titanium Grade 5.

c) MULTI PLUS UNIVERSAL

MULTI PLUS UNIVERSAL is an abutment made of Polyoxomethylene (POM) which can be used for temporary and definitive constructions. It is casted by the technician with an alloy. MULTI PLUS UNIVERSAL is screwed onto the PS MultiPlus abutment (0°, 20° or 30°). It is delivered non-sterile together with a prothetic and a technician screw made of Titanium alloy grade 5 (ISO 5832-3 and ASTM F-136 compliant).

d) MultiPlus Healing posts

MultiPlus Healing posts are used for shaping the soft tissue after the osseointegration. They are made of Titanium grade 5 (ISO 5832-3 and ASTM F-136 compliant). MultiPlus Healing posts are delivered sterile.

8

Easy-Con System

The Easy-Con system consists of the PS Easy-Con abutment and the Easy-Con laboratory set.

a) PS Easy-Con abutments

PS Easy-Con abutments are prefabricated abutments which are used to retain full supported dentures in the mandible or maxilla on two to four implants. The PS Easy-Con abutment is made of Ti-6Al-4V grade 5, according to ASTM F136 and coated with titanium nitride. It is delivered non-sterile.

b) Easy-Con laboratory set

The Easy-Con laboratory set consists of two Easy-Con retention caps which are made of Titanium alloy Ti-6Al-4V grade 5, according to ASTM F136 and two Easy-Con block-out rings which are made of Silicone. Furthermore the set contains two Easy-Con production inserts (black) and two sets of Easy-Con retention inserts (transparent, pink and blue).

c) Easy-Con retention inserts

The Easy-Con retention inserts are prefabricated components that are used exclusively in conjunction with the Easy-Con retention cap for prosthesis anchorage. The different colored retention inserts differ in the withdrawal force and the possible divergence compensation inserts are made of nylon.

9. Indications for use

The BEGO Semados® RS/RSX Implant System consists of implants, healing posts and abutments.

The BEGO Semados® RS/RSX implant is indicated for single or multiple unit restorations on splinted or nonsplinted applications both in the upper and lower jaw. This can be achieved by a 2-stage surgical technique in combination with immediate, early or delayed loading, depending on sufficient primary stability and appropriate occlusal loading.

The BEGO Semados® RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors.

The healing posts are indicated for patients treated with BEGO Semados® RS/RSX implants for the time during healing of the surrounding soft tissue.

The abutments are indicated for patients treated with BEGO Semados® RS/RSX implants as an aid in prosthetic rehabilitation.

PS ITA, PS TTiA and PS TTiA NH are intended to be used for a maximum period of 6 months.

9

10. Substantial equivalence discussion

The following tables compare the components of the BEGO Semados® RS/RSX Implant System to the predicate devices with respect to indications for use, intended use/principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject devices do not raise any new issues of safety or effectiveness based on the similarities to the predicate devices.

10

Table 5C – Comparison of characteristics for BEGO Semados® RS/RSX implants

	Subject device	Primary predicate device (K142260)	Reference predicate device (K090716)	Comparison
Trade Name	BEGO Semados® RS/RSX implants	NobelActive®	BEGO Semados® S implant
Picture	Image: BEGO Semados RS implant and BEGO Semados RSX implant
RS
RSX	Image: NobelActive implant	Image: BEGO Semados S implant	N/A
Indications for use	The BEGO Semados® RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading, depending on sufficient primary stability and appropriate occlusal loading.
The BEGO Semados® RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors.	NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.
NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.
NobelActive® 3.0 implants are indicated for single unit restorations only.	The BEGO Semados® S-line threaded endosseous dental implants are indicated for restorations in the upper and lower jaw (single tooth replacement, abutments for bridgework, partial or complete edentulism).	Similar to primary predicate device, both are indicated for single or multiple prosthesis of partially or completely edentulous jaws. Both are intended for surgical placement in upper or lower jaw.
Similar to primary predicate device, both include 3.0 diameter implants.
	Subject device	Primary predicate device (K142260)	Reference predicate
device (K090716)	Comparison
Trade Name	BEGO Semados® RS/RSX implants	NobelActive®	BEGO Semados® S
implant
Implant type	Root form endosseous dental
implant	Root form endosseous dental implant	Root form
endosseous dental
implant	Same
Anatomical location	Lower and upper jaw	Lower and upper jaw	Lower and upper jaw	Same
Placement method	One- or two-stage surgical
procedure	One- or two-stage surgical procedure	One- or two-stage
surgical procedure	Same
Clinical indication	Single or multiple unit
restorations
3.0 mm for single unit restorations
only	Single or multiple unit restorations
3.0 mm for single unit restorations only	Single or multiple
unit restorations	Same
Single-use	Single use only	Single use only	Single use only	Same
Implant diameters
(Ø) and lengths (L)
[mm]	Ø 3.0: L10, L11.5, L13
Ø 3.75: L8.5, L10, L11.5, L13, L15
Ø 4.1: L7, L8.5, L10, L11.5, L13, L15
Ø 4.5: L7, L8.5, L10, L11.5, L13, L15
Ø 5.5: L7, L8.5, L10, L11.5, L13	Ø 3.0: L10, L11.5, L13, L15
Ø 3.5: L8.5, L10, L11.5, L13, L15, L18
Ø 4.3: L8.5, L10, L11.5, L13, L15, L18
Ø 5.0: L8.5, L10, L11.5, L13, L15, L18
Ø5.5: 7.0, 8.5, 10, 11.5, 13.0, 15.0	Ø 3.25: L8.5, L10,
L11.5, L13, L15
Ø 3.75: L8.5, L10,
L11.5, L13, L15
Ø 4.1: L7, L8.5, L10,
L11.5, L13, L15
Ø 4.5: L8.5, L10,
L11.5, L13, L15
Ø 5.5: L8.5, L10,
L11.5, L13	Similar, all diameters and
lengths are within the
range of the predicate
devices.
Endosseous implant
material	Commercially Pure Titanium
Grade 4 acc. to ASTM F67, ISO
5832-2	Commercially Pure Titanium Grade 4
acc. to ASTM F67, ISO 5832-2	Commercially Pure
Titanium Grade 4
acc. to ASTM F67,
ISO 5832-2	Same
	Subject device	Primary predicate device (K142260)	Reference predicate
device (K090716)	Comparison
Trade Name	BEGO Semados® RS/RSX implants	NobelActive®	BEGO Semados® S
implant
Implant accessories	Cover screws 3.0-5.5 mm made of
Titanium Grade 4
Insertion post 3.0-5.5 mm made
of Titanium Grade 5	Cover Screws 3.0-5.5 mm made of
titanium alloy TI-6Al-4V (Grade 5)
No insertion posts included	Cover screws 3.25-5.5
mm made of Titanium
Grade 4
Insertion post 3.25-
5.5 mm made of
Titanium Grade 5	Similar, except for the
insertion posts and the
material supported by a
reference predicate
device BEGO Semados®
S implant.
Design	Self-tapping dental implant with
internal hex connection	Self-tapping dental implant with
Internal hex connection	Self-tapping dental
implant with internal
hex connection	Same
Implant shape	Straight/ parallel (upper part)
Tapered (lower part)	Straight/parallel (upper part)
Tapered (lower part)	Straight/ parallel
(upper part)
Tapered (lower part)	Same
Thread design	Self-tapping
Two circular cutting edges
in the apical and central region
Thread depth of 0.35 mm to 0.49
mm in the conical part	Self-tapping, two circular cutting
grooves in the lower part
Reverse cutting flutes	Self-tapping
Four ship spaces and
cutting edges in the
apical region
Thread depth of 0.35
mm to 0.49 mm in
the conical part	Similar
	Subject device	Primary predicate device (K142260)	Reference predicate device (K090716)	Comparison
Trade Name	BEGO Semados® RS/RSX implants	NobelActive®	BEGO Semados® S implant
Implant-to-
abutment
connection	Conical (45° taper) connection
Anti-rotation protection (Internal
Hexagon)
Platform Switch	Conical-tapered connection
Anti-rotation protection (Internal
Hexagon)
Platform Switch	Conical (45° taper)
connection
Anti-rotation protection (Internal
Hexagon)
Platform Match	Same/ Similar
	Surface	TiPurePlus microstructure	TiUnite (titanium oxide, anodized)	TiPurePlus microstructure
Surface treatment	Sandblasted and etched	Electrochemically modified	Sandblasted and
etched	Different but supported
by the same surface
treatment of the
reference predicate
device

11

12

13

14

Table 5D – Comparison of characteristics for PS HP and PS HPW

| | Subject device | Primary predicate device
(K090716) | Reference predicate device
(K102436) | Comparison |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | PS HP and PS HPW | Healing posts | Healing Abutments | |
| Picture | Image: PS HP and PS HPW | Image: Healing posts | Image: Healing Abutments | N/A |
| Indications for
use | The healing posts are indicated
for patients treated with BEGO
Semados® RS/RSX implants for
the time during healing of the
surrounding soft tissue. | The healing posts are indicated
for patients treated with BEGO
Semados® S implants for the
time during healing of the
surrounding soft tissue. | The Healing Abutments are
premanufactured prosthetic
components to be directly
connected to the endosseous
dental implants and are
indicated as temporary
components for one single
tooth to full arch denture
procedures. | Similar |
| Single use only | Yes | Yes | Yes | Same |
| Size (diameter
and gingiva
height) | PS HP: $Ø$ 3.0, 4.0, 4.5, 5.0, 5.5,
6.5 mm with gingiva heights of 3,
5 and 7 mm (available for all
diameters)
PS HPW: $Ø$ 5.5, 6.0, 6.5, 7.0 with
gingiva heights of 3, 5 and 7mm
(available for all diameters) | $Ø$ 4.0, 4.5, 5.0, 6.0 mm with
gingiva heights of 3, 5 and 7
mm (available for all
diameters) | $Ø$ 3.2 and 3.8 mm with gingiva
heights 3, 5 and 7 mm
(available for all diameters) | Similar,
additional
diameter for the
3.0 implant,
broader range
of diameters
due to
individual soft
tissue situations |
| Healing post
material | Titanium Grade 5 (Ti6Al4V)
ASTM F136 ISO 5832-3 | Titanium Grade 5 (Ti6Al4V)
ASTM F136 ISO 5832-3 | Titanium alloy Ti6Al4V | Same |
| | Subject device | Primary predicate device
(K090716) | Reference predicate device
(K102436) | Comparison |
| Trade name | PS HP and PS HPW | Healing posts | Healing Abutments | |
| Healing post
design | Soft tissue management (upper
part)
Tapered (lower part) | Soft tissue management (upper
part)
Tapered (lower part) | Soft tissue management (upper
part)
Tapered (lower part) | Same |
| Implant-to-
Healing post
connection | Conical (45° taper) connection,
without rotation protection
(cylinder) | Conical (45° taper) connection,
without rotation protection
(cylinder) | Conical connection, without
rotation protection
(cylinder) | Same |
| | Subject device | Reference predicate device (K161435) | Comparison | |
| Trade name | PS TTIA and PS TTIA NH | Temporary Snap Abutment | | |
| Picture | Image: PS TTIA and PS TTIA NH | Image: Temporary Snap Abutment | N/A | |
| Indications for use | The abutments are indicated for patients
treated with BEGO Semados® RS/RSX
implants as an aid in prosthetic
rehabilitation.
PS TTIA and PS TTIA NH are intended to be
used for a maximum period of 6 months. | The Temporary Snap Abutment is intended
to be used to fabricate and support
provisional restorations that aid in creating
an esthetic emergence through the gingiva
during the healing period and prior to final
restoration. The Temporary Snap
Abutment can be used for cement retained
or screw-retained provisional restorations.
The abutments can be used for single-unit
and multi-unit restorations. Use of the
Temporary Snap Abutment is not to exceed
one hundred and eighty (180) days. | Similar | |
| Single use only | Yes | Yes | Same | |
| Abutment
interface and
overall height | Abutment interface: 3.2, 3.7, 4.1, 5.1 mm
Overall height: 12 mm | Abutment interface: 3.0, 3.4, 3.4, 4.4 mm
Overall height: 8.5, 10, 12 mm | Similar, diameters are
due to the compatible
implants. Height of
subject devices may be
customized. | |
| Abutment material | Titanium Grade 5 (Ti6Al4V) ASTM F136 ISO
5832-3 | Abutments and screws — Titanium
vanadium alloy (ASTM F1472, ASTM F136) | Similar, ASTM F1472 is a
Ti6Al4V alloy | |
| Abutment design | Straight with retentive grooves (upper part),
tapered (lower part) | Straight with retentive grooves (upper
part), tapered (lower part) | Same | |
| | Subject device | Reference predicate device (K161435) | Comparison | |
| Trade name | PS TTiA and PS TTiA NH | Temporary Snap Abutment | | |
| Implant-to-
abutment
connection | Conical (45° taper) connection
PS TTiA: with anti-rotation protection
(hexagon)
PS TTiA NH: no-rotation protection (cylinder | Internal Conical Connection with
integrated snap feature, designed to
facilitate prosthetic try in
No-rotation protection (cylinder | Similar, the basic
geometry of the
connection is
equivalent. | |
| Duration of use | ≤ 6 month | 180 days | Same | |
| | Subject device | Reference predicate device (K102436) | Comparison | |
| Trade name | PS ITA | Immediate Temporary Abutment | | |
| Picture | Image: PS ITA | Image: Immediate Temporary Abutment | N/A | |
| Indications for use | The abutments are indicated for patients
treated with BEGO Semados® RS/RSX
implants as an aid in prosthetic
rehabilitation.
PS ITA are intended to be used for a
maximum period of 6 months. | Immediate Temporary Abutment is a
premanufactured prosthetic component
directly connected to the endosseous dental
implant and is intended for use as an aid in
prosthetic rehabilitation.
Immediate Temporary Abutment Conical
Connection 3.0 is indicated for use in the
treatment of missing maxillary single lateral
incisors or in the mandibular central and
lateral incisors. | Similar, except for the
time period. The subject
device may only be used
up to six months. | |
| Single use only | Yes | Yes | Same | |
| Abutment
interface and
overall height | Abutment interface: 2.6, 3.2, 3.7, 4.1 mm
Abutment height: 7.1 mm | Abutment interface: 2.5, 3.0, 3.4, 3.4
Abutment height: 6.5, 8 mm | Similar, the labeling of
the reference predicate
device indicates that the
device is available for all
diameters of the
compatible implant | |
| Abutment material | Titanium Grade 5 (Ti6Al4V) ASTM F136,
ISO 5832-3 | Titanium vanadium alloy
(ASTM F136) | Same | |
| | Subject device | Reference predicate device (K102436) | Comparison | |
| Trade name | PS ITA | Immediate Temporary Abutment | | |
| Abutment design | Straight (upper part), anatomically shaped (middle part), tapered with a cylinder and integrated connection screw (lower part) | Straight/parallel (upper part), tapered with integrated connection screw (lower part) | Similar, the reference predicate device has no anatomically shaped middle part | |
| Implant-to-abutment connection | Conical (45° taper) connection, without rotation protection (cylinder) | Conical connection, without rotation protection (cylinder) | Similar, the basic geometry of the connection is equivalent. | |
| Duration of use | $\leq$ 6 month | Temporary without further specification | Similar, the subject device limits the use for six months. | |
| Trade name | Subject device | Primary predicate device (K090716) | Reference predicate device (K102436) | Comparison |
| Picture | Image: PS TiA and PS TiAA abutments | Image: Sub-Tec Titanium abutment anatomical | Image: Esthetic Abutment and 15° Esthetic Abutment | N/A |
| Indications for use | The abutments are indicated
for patients treated with BEGO
Semados® RS/RSX implants as
an aid in prosthetic
rehabilitation. | Sub-Tec Titanium
abutments
anatomical are
screwed directly into
the implant and are
used exclusively to
make single tooth
restorations /
cement-retained
restorations (crowns
and bridges) due to
their antirotation
protection. | Esthetic Abutment is a
premanufactured prosthetic
component directly connected
to the endosseous dental
implant and is intended for use
as an aid in prosthetic
rehabilitation.
Esthetic Abutment Conical
Connection 3.0 is indicated for
use in the treatment of missing
maxillary lateral incisors or in
the mandibular central and
lateral incisors. | Similar, the primary
predicate device does
not contain angulated
abutments nor 3.0 mm
diameter. The reference
predicate device
contains the angulated
abutment for the
diameter reduced
implant. |
| Single use only | Yes | Yes | Yes | Same |
| Abutment
interface and
overall height | Abutment interface: 2.7, 3.2,
3.7, 4.1, 5.1 mm
Gingiva height: 1-2 mm | Abutment interface:
3.75, 4.1, 4.5, 5.5 mm
Gingiva height: 1-2 mm | Abutment interface: 2.5, 3.0, 3.4,
3.4, 4.4 mm | Similar, different abutment
interfaces are due to the
Platform Switch concept of
the subject vs. Platform
Match concept of the |
| | Subject device | Primary predicate
device (K090716) | Reference predicate device
(K102436) | Comparison |
| Trade name | PS TIA and PS TIAA | Sub-Tec Titanium
abutment anatomical | Esthetic Abutment
and 15° Esthetic Abutment | |
| Abutment angle | 0°, 15°, 20° | 0° | 0°, 15° | Similar, the predicate
devices do not contain 20°
angled abutments |
| Abutment material | Titanium Grade 5 (Ti6Al4V)
ASTM F136 ISO 5832-3 | Titanium Grade 4
ASTM F67 ISO 5832-2 | Titanium alloy Ti6Al4V | Similar, both materials
are well-established
because of their good
biocompatibility
performance |
| Abutment design | Straight or angled (upper
part), different anatomical
heights (middle part), tapered
(lower part) | Straight (upper part),
anatomical design
(middle part), tapered
(lower part) | Straight or angled (upper part),
different anatomical heights
(middle part), tapered (lower
part) | Same |
| Implant-to-
abutment
connection | Conical (45° taper) connection,
with anti-rotation protection
(hexagon) | Conical (45° taper)
connection, with anti-
rotation protection
(hexagon) | Conical connection, with anti-
rotation protection (hexagon) | Same |
| | Subject device | Reference predicate device (K161416) | Comparison | |
| Trade name | MultiPlus system | Multi Unit Abutment Plus | | |
| Picture | Image: MultiPlus system | Image: Multi Unit Abutment Plus | N/A | |
| Indications for use | The abutments are indicated for patients
treated with BEGO Semados® RS/RSX
implants as an aid in prosthetic
rehabilitation. | The Multi-unit Abutment Plus is a
premanufactured prosthetic component
directly connected to the endosseous dental
implant and is intended for use as an aid in
prosthetic rehabilitation. | Similar | |
| Single use only | Yes | Yes | Same | |
| Abutment
interface and
overall height | Abutment interface:
3.2, 4.1, 4.5 mm

Gingiva height:
0°: 1 and 3 mm
20°: 2.3-0.6 mm and 4.0-2.3 mm
30°: 4.0-1.5 mm | Abutment interface:
3.0, 3.4, 3.4, 4.4 mm

15

16

Table 5E – Comparison of characteristics for PS TTiA and PS TTiA NH

17

18

Table 5F – Comparison of characteristics for PS ITA

19

20

Table 5G – Comparison of characteristics for PS TiA and PS TiAA

21

22

Table 5H – Comparison of characteristics for MultiPlus system

23

24

Table 51 – Comparison of characteristics for Easy-Con system

25

26

11. Non-clinical performance data

As part of demonstrating safety and effectiveness of BEGO Semados® RS/RSX Implant System, and in showing substantial equivalence to the predicate devices, BEGO Implant Systems GmbH & Co. KG completed a number of non-clinical performance tests. The BEGO Semados® RS/RSX Implant System meets all the requirements for overall design, sterilization, biocompatibility, and performance confirming that the design output meets the design inputs and specifications for the device.

The BEGO Semados® RS/RSX Implant System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject devices.

The materials were qualified according to ISO 5832-2:2018-03, ISO 5832-3:2016-10, ASTM F136-13 and ASTM F67-17 for Titanium Grade 4 and Titanium Grade 5 Material Specifications.

The biocompatibility was tested for contacting materials including cytotoxicity, sensitization reactivity per ISO 10993-5:2009-06 "Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity" (XTT assay using mouse cell line 1929 examined microscopically using phase contrast microscopy), ISO 10993-10:2010-08 "Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization" (Test for delayed-type hypersensitivity Guinea pig maximization test) and ISO 10993-3:2014-10 "Biological evaluation of medical devices - Part 3: Tests for genotoxicity and reproductive toxicity" (Ames reverse mutation assay: gene mutations in bacteria Salmonella typhimurium).

A bacterial endotoxin testing was conducted for subject devices supplied as sterile according to USP 42-NF37 , issued 2019.

The functional and mechanical properties were evaluated through physical testing:

Static and dynamic fatigue tests were performed on BEGO Semados® RS/RSX implants in accordance । with ISO 14801:2007-11 and ISO 14801:2016-11 "Dentistry - Implants-Dynamic fatigue test for endosseous dental implants" and 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, issued March 12, 2004" representing the most critical situation possible. BEGO Semados® RS/RSX implants were tested with PS TiA, PS TiAA and PS MultiPlus abutments;
-Energy disperse X-ray spectroscopy (EDX-analysis) and roughness test on surface were performed to evaluate the material composition at the implant surface level in line with ISO 4287:1997-04 "Geometrical Product Specification (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parameters" and ISO 4288:1996-08 "Geometrical Product Specifications (GPS) -Surface texture: Profile method - Rules and procedures for the assessment of surface texture" ;
Static immersion and open circuit potential measurements of BEGO dental abutments and BEGO Semados® RS/RSX implants have been conducted according to ISO 10271:2001-06 to determine the corrosion resistance.

A sterilization testing according to ISO 11137-2:2013-06 "Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose", ISO 11737-1:2018-01 "Sterilization of health care products -Microbiological methods - Part 1: Determination of microorganisms on product" and ISO 11737-2:2009-11 "Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process" was conducted for

27

gamma-sterilized BEGO Semados® RS/RSX Implants, Implant Cover Screws, Healing posts PS HP and PS HPW, PS MultiPlus, MultiPlus Healing posts and MultiPlus Titanium abutment.

A sterility assurance level (SAL) of 10 ° was validated in accordance with ISO 11137-2:2013-06 "Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose".

A sterilization validation according to ISO 17665-1:2006-08 "Sterilization of health care products – Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices", and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015" was conducted for end-user sterilized PS ITA, PS TTIA, PS TTIA NH, PS TiA, PS TiAA and PS Easy-Con, which are initially supplied as non-sterile.

A shelf life and transport packaging testing was conducted according to ISO 11607-1:2019-02 "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems", ISO 11607-2:2019-02 "Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes", ASTM F88/F88M-09 "Standard Test Method for Seal Strength of Flexible Barrier Materials" , ASTM F1886/F1886M-09 "Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection", ASTM F1980-11 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices", ASTM F1929-12 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration", ASTM F2096-11 "Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)", EN 868-5:2009 "Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods" and ISTA 2A:2011 "Packagedproducts 150 lb. (68 kg) or less".

A usability engineering testing was conducted per IEC 62366-1:2015-02 "Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]", all requirements were met.

A risk management was assessed per ISO 14971:2007-03 "Medical devices - Application of risk management to medical devices", all requirements were met and risks reduced as far as possible.

A MR Safety investigation of BEGO Semados® implants and abutments was conducted and included a Displacement force test according to ASTM F2052-15, a Torque test according to ASTM F2213-06 (2011), a RF heating test according to ASTM F2182-11a and a MR image artefacts test according to ASTM F2119-07 (2013). It was demonstrated that BEGO Semados® implants and abutments are MR Conditional.

12. Clinical performance data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

13. Statement of substantial equivalence

Based on the information provided, the BEGO Semados® RS/RSX Implant System as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).