BEGO Semados® RS/RSX Implant System

K201700 · Bego Implant Systems GmbH & Co. KG · DZE · Jan 13, 2021 · Dental

Device Facts

• Record ID: K201700
• Device Name: BEGO Semados® RS/RSX Implant System
• Applicant: Bego Implant Systems GmbH & Co. KG
• Product Code: DZE · Dental
• Decision Date: Jan 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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.

Device Story

BEGO Semados® RS/RSX Implant System comprises self-tapping, conical endosseous dental implants, healing posts, and abutments. Implants are placed subgingivally in upper/lower jaw to replace missing teeth. System includes cover screws and insertion posts for surgical placement. Abutments connect to implants to support temporary or permanent prosthetic restorations. Used in dental clinics by trained clinicians. Device provides stable foundation for crowns, bridges, or overdentures. Benefits include restoration of esthetics and chewing function. System includes specialized components like MultiPlus (for bridge/full denture constructions) and Easy-Con (for overdenture retention).

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including static/dynamic fatigue (ISO 14801), biocompatibility (ISO 10993), corrosion resistance (ISO 10271), sterilization validation, and MR safety (ASTM F2052, F2213, F2182, F2119).

Technological Characteristics

Materials: Commercially pure Titanium Grade 4 (ASTM F67, ISO 5832-2) and Titanium Grade 5 (ASTM F136, ISO 5832-3). Design: Self-tapping, conical endosseous implants with internal hex connection and platform switch design. Surface: Sandblasted and etched. Sterilization: Gamma radiation (sterile components) or end-user moist heat (non-sterile components).

Indications for Use

Indicated for single or multiple unit dental restorations in upper/lower jaw via 1-stage or 2-stage surgery with immediate, early, or delayed loading. 3.0mm implants indicated for single unit restorations of lower lateral/central incisors or upper lateral incisors. Healing posts for soft tissue healing; abutments for prosthetic rehabilitation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NobelActive (K142260)
• BEGO Semados® S-Line (K090716)

Reference Devices

• BEGO Semados® S implant (K090716)
• Temporary Snap Abutment (K161435)
• NobelActive 3.0 (K102436)
• Multi-unit Abutment Plus (K161416)
• Modification To Locator Implant Anchor (K072878)

Submission Summary (Full Text)

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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.

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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/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 ([e-mail]) or phone [phone] 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

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# 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)

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# 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: [phone] Fax: [phone] 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: [phone] E-Mail: [e-mail]

## 3. Application Correspondent

Bertrand Lecointe, Regulatory Affairs Manager BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 28359 Bremen, Germany Phone: [phone] E-Mail: [e-mail]

## 4. US Agent (contact)

Frederick J. Horstkotte BEGO USA, Inc. 24 Albion Road Suite No. 103 Lincoln, RI 02865 Phone: [phone] Ext Fax: [phone] E-Mail: [e-mail]

## 5. Date prepared

1/13/2021

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# 6. Device identification

| Trade/Proprietary name: | BEGO Semados® RS/RSX Implant System |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| Classification name: | Endosseous dental implant (21 CFR 872.3640)<br>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<br>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<br>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<br>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.<br>KG, GERMANY |
| 510(k) number of reference predicate device: K161435<br>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<br>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<br>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<br>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<br>for Endosseous Dental Implant | ZEST Anchors Inc., USA |

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

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#### 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.

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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.

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## 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.

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#### 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.

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# 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<br>RS<br>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.<br>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.<br>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.<br>NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.<br>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.<br>Similar to primary predicate device, both include 3.0 diameter implants. |
| | Subject device | Primary predicate device (K142260) | Reference predicate<br>device (K090716) | Comparison |
| Trade Name | BEGO Semados® RS/RSX implants | NobelActive® | BEGO Semados® S<br>implant | |
| Implant type | Root form endosseous dental<br>implant | Root form endosseous dental implant | Root form<br>endosseous dental<br>implant | Same |
| Anatomical location | Lower and upper jaw | Lower and upper jaw | Lower and upper jaw | Same |
| Placement method | One- or two-stage surgical<br>procedure | One- or two-stage surgical procedure | One- or two-stage<br>surgical procedure | Same |
| Clinical indication | Single or multiple unit<br>restorations<br>3.0 mm for single unit restorations<br>only | Single or multiple unit restorations<br>3.0 mm for single unit restorations only | Single or multiple<br>unit restorations | Same |
| Single-use | Single use only | Single use only | Single use only | Same |
| Implant diameters<br>(Ø) and lengths (L)<br>[mm] | Ø 3.0: L10, L11.5, L13<br>Ø 3.75: L8.5, L10, L11.5, L13, L15<br>Ø 4.1: L7, L8.5, L10, L11.5, L13, L15<br>Ø 4.5: L7, L8.5, L10, L11.5, L13, L15<br>Ø 5.5: L7, L8.5, L10, L11.5, L13 | Ø 3.0: L10, L11.5, L13, L15<br>Ø 3.5: L8.5, L10, L11.5, L13, L15, L18<br>Ø 4.3: L8.5, L10, L11.5, L13, L15, L18<br>Ø 5.0: L8.5, L10, L11.5, L13, L15, L18<br>Ø5.5: 7.0, 8.5, 10, 11.5, 13.0, 15.0 | Ø 3.25: L8.5, L10,<br>L11.5, L13, L15<br>Ø 3.75: L8.5, L10,<br>L11.5, L13, L15<br>Ø 4.1: L7, L8.5, L10,<br>L11.5, L13, L15<br>Ø 4.5: L8.5, L10,<br>L11.5, L13, L15<br>Ø 5.5: L8.5, L10,<br>L11.5, L13 | Similar, all diameters and<br>lengths are within the<br>range of the predicate<br>devices. |
| Endosseous implant<br>material | Commercially Pure Titanium<br>Grade 4 acc. to ASTM F67, ISO<br>5832-2 | Commercially Pure Titanium Grade 4<br>acc. to ASTM F67, ISO 5832-2 | Commercially Pure<br>Titanium Grade 4<br>acc. to ASTM F67,<br>ISO 5832-2 | Same |
| | Subject device | Primary predicate device (K142260) | Reference predicate<br>device (K090716) | Comparison |
| Trade Name | BEGO Semados® RS/RSX implants | NobelActive® | BEGO Semados® S<br>implant | |
| Implant accessories | Cover screws 3.0-5.5 mm made of<br>Titanium Grade 4<br>Insertion post 3.0-5.5 mm made<br>of Titanium Grade 5 | Cover Screws 3.0-5.5 mm made of<br>titanium alloy TI-6Al-4V (Grade 5)<br>No insertion posts included | Cover screws 3.25-5.5<br>mm made of Titanium<br>Grade 4<br>Insertion post 3.25-<br>5.5 mm made of<br>Titanium Grade 5 | Similar, except for the<br>insertion posts and the<br>material supported by a<br>reference predicate<br>device BEGO Semados®<br>S implant. |
| Design | Self-tapping dental implant with<br>internal hex connection | Self-tapping dental implant with<br>Internal hex connection | Self-tapping dental<br>implant with internal<br>hex connection | Same |
| Implant shape | Straight/ parallel (upper part)<br>Tapered (lower part) | Straight/parallel (upper part)<br>Tapered (lower part) | Straight/ parallel<br>(upper part)<br>Tapered (lower part) | Same |
| Thread design | Self-tapping<br>Two circular cutting edges<br>in the apical and central region<br>Thread depth of 0.35 mm to 0.49<br>mm in the conical part | Self-tapping, two circular cutting<br>grooves in the lower part<br>Reverse cutting flutes | Self-tapping<br>Four ship spaces and<br>cutting edges in the<br>apical region<br>Thread depth of 0.35<br>mm to 0.49 mm in<br>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-<br>abutment<br>connection | Conical (45° taper) connection<br>Anti-rotation protection (Internal<br>Hexagon)<br>Platform Switch | Conical-tapered connection<br>Anti-rotation protection (Internal<br>Hexagon)<br>Platform Switch | Conical (45° taper)<br>connection<br>Anti-rotation protection (Internal<br>Hexagon)<br>Platform Match | Same/ Similar |
| | Surface | TiPurePlus microstructure | TiUnite (titanium oxide, anodized) | TiPurePlus microstructure |
| Surface treatment | Sandblasted and etched | Electrochemically modified | Sandblasted and<br>etched | Different but supported<br>by the same surface<br>treatment of the<br>reference predicate<br>device |

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

| | Subject device | Primary predicate device<br>(K090716) | Reference predicate device<br>(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<br>use | The healing posts are indicated<br>for patients treated with BEGO<br>Semados® RS/RSX implants for<br>the time during healing of the<br>surrounding soft tissue. | The healing posts are indicated<br>for patients treated with BEGO<br>Semados® S implants for the<br>time during healing of the<br>surrounding soft tissue. | The Healing Abutments are<br>premanufactured prosthetic<br>components to be directly<br>connected to the endosseous<br>dental implants and are<br>indicated as temporary<br>components for one single<br>tooth to full arch denture<br>procedures. | Similar |
| Single use only | Yes | Yes | Yes | Same |
| Size (diameter<br>and gingiva<br>height) | PS HP: $Ø$ 3.0, 4.0, 4.5, 5.0, 5.5,<br>6.5 mm with gingiva heights of 3,<br>5 and 7 mm (available for all<br>diameters)<br>PS HPW: $Ø$ 5.5, 6.0, 6.5, 7.0 with<br>gingiva heights of 3, 5 and 7mm<br>(available for all diameters) | $Ø$ 4.0, 4.5, 5.0, 6.0 mm with<br>gingiva heights of 3, 5 and 7<br>mm (available for all<br>diameters) | $Ø$ 3.2 and 3.8 mm with gingiva<br>heights 3, 5 and 7 mm<br>(available for all diameters) | Similar,<br>additional<br>diameter for the<br>3.0 implant,<br>broader range<br>of diameters<br>due to<br>individual soft<br>tissue situations |
| Healing post<br>material | Titanium Grade 5 (Ti6Al4V)<br>ASTM F136 ISO 5832-3 | Titanium Grade 5 (Ti6Al4V)<br>ASTM F136 ISO 5832-3 | Titanium alloy Ti6Al4V…