(205 days)
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.
The BEGO Semados® RS/RSX Implant System consists of implants, healing posts and abutments.
BEGO Semados® RS/RSX implants are self-tapping, conical endosseous dental implants made of commercially pure titanium Grade 4. 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.
The healing posts are sterile packaged Titanium Grade 5 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 abutments are prefabricated prosthetic components made of Titanium Grade 5 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. 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.
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. The MultiPlus system is intended for occlusal screw-retained bridge, full dentures and bar constructions in the mandible and maxilla.
The Easy-Con system consists of the PS Easy-Con abutment and the Easy-Con laboratory set. The Easy-Con system is used to retain full supported dentures in the mandible or maxilla on two to four implants.
The provided document is a 510(k) Premarket Notification for the BEGO Semados® RS/RSX Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with pre-defined acceptance criteria.
Therefore, the document does not contain the kind of information requested in your prompt (e.g., acceptance criteria for an AI/ML model's performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or training set details). The "performance data" section (Section 11) refers to non-clinical testing of the physical implant system, such as biocompatibility, mechanical properties (fatigue, corrosion), and sterilization, typical for traditional medical devices. Section 12 explicitly states that "no human clinical testing was required."
This submission is about demonstrating that a new dental implant system is as safe and effective as existing, legally marketed implant systems, based on similar technology, materials, and non-clinical performance characteristics. It is not an AI/ML device submission.
Thus, I cannot extract the requested information as it is not present in the provided 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 (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
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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: +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
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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)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: K142260Device 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: K090716Device 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: K090716Device 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: K161435Device 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: K102436Device 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: K161416Device 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: K072878Device 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 Abutmentfor 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 implantRSRSX | 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 predicatedevice (K090716) | Comparison | |
| Trade Name | BEGO Semados® RS/RSX implants | NobelActive® | BEGO Semados® Simplant | |
| Implant type | Root form endosseous dentalimplant | Root form endosseous dental implant | Root formendosseous dentalimplant | Same |
| Anatomical location | Lower and upper jaw | Lower and upper jaw | Lower and upper jaw | Same |
| Placement method | One- or two-stage surgicalprocedure | One- or two-stage surgical procedure | One- or two-stagesurgical procedure | Same |
| Clinical indication | Single or multiple unitrestorations3.0 mm for single unit restorationsonly | Single or multiple unit restorations3.0 mm for single unit restorations only | Single or multipleunit 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, L13Ø 3.75: L8.5, L10, L11.5, L13, L15Ø 4.1: L7, L8.5, L10, L11.5, L13, L15Ø 4.5: L7, L8.5, L10, L11.5, L13, L15Ø 5.5: L7, L8.5, L10, L11.5, L13 | Ø 3.0: L10, L11.5, L13, L15Ø 3.5: L8.5, L10, L11.5, L13, L15, L18Ø 4.3: L8.5, L10, L11.5, L13, L15, L18Ø 5.0: L8.5, L10, L11.5, L13, L15, L18Ø5.5: 7.0, 8.5, 10, 11.5, 13.0, 15.0 | Ø 3.25: L8.5, L10,L11.5, L13, L15Ø 3.75: L8.5, L10,L11.5, L13, L15Ø 4.1: L7, L8.5, L10,L11.5, L13, L15Ø 4.5: L8.5, L10,L11.5, L13, L15Ø 5.5: L8.5, L10,L11.5, L13 | Similar, all diameters andlengths are within therange of the predicatedevices. |
| Endosseous implantmaterial | Commercially Pure TitaniumGrade 4 acc. to ASTM F67, ISO5832-2 | Commercially Pure Titanium Grade 4acc. to ASTM F67, ISO 5832-2 | Commercially PureTitanium Grade 4acc. to ASTM F67,ISO 5832-2 | Same |
| Subject device | Primary predicate device (K142260) | Reference predicatedevice (K090716) | Comparison | |
| Trade Name | BEGO Semados® RS/RSX implants | NobelActive® | BEGO Semados® Simplant | |
| Implant accessories | Cover screws 3.0-5.5 mm made ofTitanium Grade 4Insertion post 3.0-5.5 mm madeof Titanium Grade 5 | Cover Screws 3.0-5.5 mm made oftitanium alloy TI-6Al-4V (Grade 5)No insertion posts included | Cover screws 3.25-5.5mm made of TitaniumGrade 4Insertion post 3.25-5.5 mm made ofTitanium Grade 5 | Similar, except for theinsertion posts and thematerial supported by areference predicatedevice BEGO Semados®S implant. |
| Design | Self-tapping dental implant withinternal hex connection | Self-tapping dental implant withInternal hex connection | Self-tapping dentalimplant with internalhex 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-tappingTwo circular cutting edgesin the apical and central regionThread depth of 0.35 mm to 0.49mm in the conical part | Self-tapping, two circular cuttinggrooves in the lower partReverse cutting flutes | Self-tappingFour ship spaces andcutting edges in theapical regionThread depth of 0.35mm to 0.49 mm inthe 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-abutmentconnection | Conical (45° taper) connectionAnti-rotation protection (InternalHexagon)Platform Switch | Conical-tapered connectionAnti-rotation protection (InternalHexagon)Platform Switch | Conical (45° taper)connectionAnti-rotation protection (InternalHexagon)Platform Match | Same/ Similar |
| Surface | TiPurePlus microstructure | TiUnite (titanium oxide, anodized) | TiPurePlus microstructure | |
| Surface treatment | Sandblasted and etched | Electrochemically modified | Sandblasted andetched | Different but supportedby the same surfacetreatment of thereference predicatedevice |
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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 foruse | The healing posts are indicatedfor patients treated with BEGOSemados® RS/RSX implants forthe time during healing of thesurrounding soft tissue. | The healing posts are indicatedfor patients treated with BEGOSemados® S implants for thetime during healing of thesurrounding soft tissue. | The Healing Abutments arepremanufactured prostheticcomponents to be directlyconnected to the endosseousdental implants and areindicated as temporarycomponents for one singletooth to full arch dentureprocedures. | Similar |
| Single use only | Yes | Yes | Yes | Same |
| Size (diameterand gingivaheight) | 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 alldiameters)PS HPW: $Ø$ 5.5, 6.0, 6.5, 7.0 withgingiva heights of 3, 5 and 7mm(available for all diameters) | $Ø$ 4.0, 4.5, 5.0, 6.0 mm withgingiva heights of 3, 5 and 7mm (available for alldiameters) | $Ø$ 3.2 and 3.8 mm with gingivaheights 3, 5 and 7 mm(available for all diameters) | Similar,additionaldiameter for the3.0 implant,broader rangeof diametersdue toindividual softtissue situations |
| Healing postmaterial | 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 postdesign | Soft tissue management (upperpart)Tapered (lower part) | Soft tissue management (upperpart)Tapered (lower part) | Soft tissue management (upperpart)Tapered (lower part) | Same |
| Implant-to-Healing postconnection | Conical (45° taper) connection,without rotation protection(cylinder) | Conical (45° taper) connection,without rotation protection(cylinder) | Conical connection, withoutrotation 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 patientstreated with BEGO Semados® RS/RSXimplants as an aid in prostheticrehabilitation.PS TTIA and PS TTIA NH are intended to beused for a maximum period of 6 months. | The Temporary Snap Abutment is intendedto be used to fabricate and supportprovisional restorations that aid in creatingan esthetic emergence through the gingivaduring the healing period and prior to finalrestoration. The Temporary SnapAbutment can be used for cement retainedor screw-retained provisional restorations.The abutments can be used for single-unitand multi-unit restorations. Use of theTemporary Snap Abutment is not to exceedone hundred and eighty (180) days. | Similar | |
| Single use only | Yes | Yes | Same | |
| Abutmentinterface andoverall height | Abutment interface: 3.2, 3.7, 4.1, 5.1 mmOverall height: 12 mm | Abutment interface: 3.0, 3.4, 3.4, 4.4 mmOverall height: 8.5, 10, 12 mm | Similar, diameters aredue to the compatibleimplants. Height ofsubject devices may becustomized. | |
| Abutment material | Titanium Grade 5 (Ti6Al4V) ASTM F136 ISO5832-3 | Abutments and screws — Titaniumvanadium alloy (ASTM F1472, ASTM F136) | Similar, ASTM F1472 is aTi6Al4V alloy | |
| Abutment design | Straight with retentive grooves (upper part),tapered (lower part) | Straight with retentive grooves (upperpart), tapered (lower part) | Same | |
| Subject device | Reference predicate device (K161435) | Comparison | ||
| Trade name | PS TTiA and PS TTiA NH | Temporary Snap Abutment | ||
| Implant-to-abutmentconnection | Conical (45° taper) connectionPS TTiA: with anti-rotation protection(hexagon)PS TTiA NH: no-rotation protection (cylinder | Internal Conical Connection withintegrated snap feature, designed tofacilitate prosthetic try inNo-rotation protection (cylinder | Similar, the basicgeometry of theconnection isequivalent. | |
| 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 patientstreated with BEGO Semados® RS/RSXimplants as an aid in prostheticrehabilitation.PS ITA are intended to be used for amaximum period of 6 months. | Immediate Temporary Abutment is apremanufactured prosthetic componentdirectly connected to the endosseous dentalimplant and is intended for use as an aid inprosthetic rehabilitation.Immediate Temporary Abutment ConicalConnection 3.0 is indicated for use in thetreatment of missing maxillary single lateralincisors or in the mandibular central andlateral incisors. | Similar, except for thetime period. The subjectdevice may only be usedup to six months. | |
| Single use only | Yes | Yes | Same | |
| Abutmentinterface andoverall height | Abutment interface: 2.6, 3.2, 3.7, 4.1 mmAbutment height: 7.1 mm | Abutment interface: 2.5, 3.0, 3.4, 3.4Abutment height: 6.5, 8 mm | Similar, the labeling ofthe reference predicatedevice indicates that thedevice is available for alldiameters of thecompatible 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 indicatedfor patients treated with BEGOSemados® RS/RSX implants asan aid in prostheticrehabilitation. | Sub-Tec Titaniumabutmentsanatomical arescrewed directly intothe implant and areused exclusively tomake single toothrestorations /cement-retainedrestorations (crownsand bridges) due totheir antirotationprotection. | Esthetic Abutment is apremanufactured prostheticcomponent directly connectedto the endosseous dentalimplant and is intended for useas an aid in prostheticrehabilitation.Esthetic Abutment ConicalConnection 3.0 is indicated foruse in the treatment of missingmaxillary lateral incisors or inthe mandibular central andlateral incisors. | Similar, the primarypredicate device doesnot contain angulatedabutments nor 3.0 mmdiameter. The referencepredicate devicecontains the angulatedabutment for thediameter reducedimplant. |
| Single use only | Yes | Yes | Yes | Same |
| Abutmentinterface andoverall height | Abutment interface: 2.7, 3.2,3.7, 4.1, 5.1 mmGingiva height: 1-2 mm | Abutment interface:3.75, 4.1, 4.5, 5.5 mmGingiva height: 1-2 mm | Abutment interface: 2.5, 3.0, 3.4,3.4, 4.4 mm | Similar, different abutmentinterfaces are due to thePlatform Switch concept ofthe subject vs. PlatformMatch concept of the |
| Subject device | Primary predicatedevice (K090716) | Reference predicate device(K102436) | Comparison | |
| Trade name | PS TIA and PS TIAA | Sub-Tec Titaniumabutment anatomical | Esthetic Abutmentand 15° Esthetic Abutment | |
| Abutment angle | 0°, 15°, 20° | 0° | 0°, 15° | Similar, the predicatedevices do not contain 20°angled abutments |
| Abutment material | Titanium Grade 5 (Ti6Al4V)ASTM F136 ISO 5832-3 | Titanium Grade 4ASTM F67 ISO 5832-2 | Titanium alloy Ti6Al4V | Similar, both materialsare well-establishedbecause of their goodbiocompatibilityperformance |
| Abutment design | Straight or angled (upperpart), different anatomicalheights (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 (lowerpart) | Same |
| Implant-to-abutmentconnection | 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 patientstreated with BEGO Semados® RS/RSXimplants as an aid in prostheticrehabilitation. | The Multi-unit Abutment Plus is apremanufactured prosthetic componentdirectly connected to the endosseous dentalimplant and is intended for use as an aid inprosthetic rehabilitation. | Similar | |
| Single use only | Yes | Yes | Same | |
| Abutmentinterface andoverall height | Abutment interface:3.2, 4.1, 4.5 mmGingiva height:0°: 1 and 3 mm20°: 2.3-0.6 mm and 4.0-2.3 mm30°: 4.0-1.5 mm | Abutment interface:3.0, 3.4, 3.4, 4.4 mmCollar height:1.5, 2.5, 3.5, 4.5 mm | Similar | |
| Abutment angle | 0°, 20°, 30° | 0°, 17°, 30° | Similar | |
| Abutment material | Titanium Grade 5 (Ti6Al4V) ASTM F136ISO 5832-3 | Titanium alloy Ti6Al4V | Same | |
| Abutment design | Straight or angled (upper part), differentanatomical heights (middle part),tapered (lower part) | Straight or angled (upper part), anatomicaldesign (middle part), tapered (lower part) | Same | |
| Subject device | Reference predicate device (K161416) | Comparison | ||
| Trade name | MultiPlus system | Multi Unit Abutment Plus | ||
| Implant-to-abutmentconnection | Conical connection0°: no anti-rotation protection20° and 30°: with anti-rotation protection(hexagon) | Conical connection | Same | |
| Subject device | Reference predicate device (K072878) | Comparison | ||
| Trade name | Easy-Con system | Locator® Implant Anchor Abutment forEndosseous Dental Implant | ||
| Picture | Image: Easy-Con system | Image: Locator® Implant Anchor Abutment for Endosseous Dental Implant | N/A | |
| Indications for use | The abutments are indicated for patientstreated with BEGO Semados® RS/RSXimplants as an aid in prostheticrehabilitation. | The Locator® Implant Anchor Abutment forEndosseous Dental Implant is appropriatefor use with overdentures or partialdentures retained in whole or in part byendosseous implants in the mandible ormaxilla. | Similar | |
| Single use only | Yes | Yes | Same | |
| Abutmentinterface andoverall height | Abutment interface: 3.5-5.5 mmGingiva height: 1, 2, 3 and 4 mm | Abutment interface: 2.5-6.5 mmGingiva height: 1-6 mm | Similar, different abutmentinterfaces are due to thecompatibility of theLocator System with theimplant systems of variousmanufacturers | |
| Abutment angle | 0° | 0° | Same | |
| Material | Abutment: Titanium alloy Ti6Al4VAbutment coating: TiNRetention insert: nylon | Abutment: Ti6Al4V ELIAbutment coating: TiNRetention insert: nylon | Same | |
| Subject device | Reference predicate device (K072878) | Comparison | ||
| Trade name | Easy-Con system | Locator® Implant Anchor Abutment forEndosseous Dental Implant | ||
| Straight (upper part) | Straight (upper part) | |||
| Abutment design | Different anatomical heights (middle part) | Different anatomical heights (middle part) | Same | |
| Tapered (lower part) | Tapered (lower part) | |||
| Divergenceallowance | ≤ 40° between two implants with no morethan 30° angulation per implant body | ≤ 40° between two implants | Same | |
| Prosthesisattachment type | Nylon Insert engaged to DentureAttachment Housing | Nylon Insert engaged to DentureAttachment Housing | Same | |
| Implant-to-abutmentconnection | Conical, no rotation protection | Conical, External Hex, Internal Hex,Internal Multi Lobe | Similar |
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Table 5E – Comparison of characteristics for PS TTiA and PS TTiA NH
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Table 5F – Comparison of characteristics for PS ITA
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Table 5G – Comparison of characteristics for PS TiA and PS TiAA
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Table 5H – Comparison of characteristics for MultiPlus system
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Table 51 – Comparison of characteristics for Easy-Con system
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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 <85>, 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
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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).
§ 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.