(485 days)
SDS 1.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. SDS1.2_33xx implants are recommended as single-tooth implant for upper lateral and lower incisors for fixed prosthetic restorations only.
SDS 1.2 healing caps-disc, SDS .2 temporary caps and SDS 1.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS1.2 dental implant and enable the production/ fixation of long-term temporary restorations or protect the implant during healing phase for up to 180 days.
SDS1.2 dental implants are a one-piece implant system to fit a synthetic root replacement into the human jaw. The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. The SDS1.2 dental implants are used to fix the prosthetic restoration and are suitable for patients with an intolerance to metal. The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS1.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined. SDS1.2 implants are provided in different length/ diameter combinations and with 2 different shoulder designs. The implants are provided sterile in sterile packaging and are intended for single use. SDS1.2 dental implants must not be re-sterilized or disinfected either. When delivered, all SDS1.2 dental implants are mounted with the disposable SDS1.2 insertion tool.
Temporary restorations can be produced either individually or by using the prefabricated SDS1.2 Temporary cap as basis. The SDS1.2 Temporary caps are made of PEEK (polyether ether ketone). The SDS1.2 Temporary cap may only be used for screw-retaining temporary restorations with SDS1.2 standard screw (SDS1.2_SS-T) and must not be cemented. The SDS1.2 Temporary caps are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ.
SDS1.2 Healing caps-disc may be used to protect the dental implant. The Healing caps-disc are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. They can be fixed by screw-retaining with SDS1.2 standard titanium screws. The SDS1.2 Healing caps-disc are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ.
The SDS1.2 dental implant system's acceptance criteria and the study proving it meets them are described below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SDS1.2 dental implant system are primarily based on demonstrating substantial equivalence to predicate devices through various tests and compliance with established standards. The reported device performance indicates that these criteria have been met.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and ISO 10993-5 (cytotoxicity). | Components subjected to biological evaluation per ISO 10993-1, including cytotoxicity tests per ISO 10993-5. Identical materials with comparable reference devices for type and duration of patient contact. Biocompatibility demonstrated by tests for cytotoxicity, bioburden, and endotoxins by an accredited laboratory. |
| Performance Testing | Stability, surface structure analysis, fatigue testing (ISO 14801), and laboratory tests for extractable cytotoxic substances, pyrogenicity, and total organic carbon. | Fatigue testing conducted in accordance with ISO 14801. Surface investigation performed with scanning electron microscope. Laboratory testing for extractable cytotoxic substances, pyrogenicity, and total organic carbon planned and performed as per FDA Guidance. Testing results analyzed and evaluated, demonstrating the SDS1.2 Dental implants meet existing requirements and acceptance criteria like the predicate devices. |
| Sterilization Validation | Compliance with ISO 11137-2 for device sterilization. | Minimal sterilization dose of 25 Gv proved, leading to a sterility assurance level (SAL) of ≤ 10^-6 as required by DIN EN 556-1. |
| Packaging Validation | Compliance with ISO 11607-1 and ISO 11607-2. | Packaging system performance validated per ISO 11607-1 and ISO 11607-2. Validation results demonstrated packaging system fulfilled requirements during sterilization and storage for up to 5 years (accelerated aging). For non-sterile products (healing and temporary caps), end-user sterilization validation performed according to ISO 17665-1, confirming cleaning, disinfection, and sterilization processes meet defined results. |
| Material Standards | Compliance with ISO 13356 for Y-TZP zirconia ceramics. | Implants are made of Y-TZP material in accordance with ISO 13356. Healing caps-disc also made of Y-TZP (ISO 13356). |
| General Compliance | Compliance with all applicable standards. | SDS 1.2 Dental implants meet all requirements of the applicable standards listed (e.g., ISO 7405, ISO 14971, ISO 15223-1, ISO 11137-1). |
| Substantial Equivalence | Demonstrating equivalence to predicate devices in intended use, technological characteristics, packaging, sterilization, and design. | The subject device is stated to be "substantially equivalent to the selected predicate devices" in terms of intended use, technological characteristics, packaging, sterilization, and design key elements. Minor differences are covered by reference devices and do not raise new questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance
The document indicates that non-clinical testing was performed, including biocompatibility, performance testing (e.g., fatigue testing), sterilization validation, and packaging validation. However, specific sample sizes for these tests are not explicitly stated. The document only mentions that "the testing results were analyzed and evaluated" and that testing was "planned and performed."
The document also explicitly states:
- "No animal testing"
- "No clinical testing"
Therefore, there is no information on sample sizes from human, animal, or clinical trials. The provenance of the data is implicitly from laboratory testing conducted as part of the regulatory submission process, likely by the manufacturer or accredited testing facilities. The specific country of origin for the non-clinical test data is not provided, though the manufacturer is based in Switzerland.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML device that requires human expert adjudication for ground truth establishment. The ground truth for performance evaluation is established through objective physical and chemical test methods and compliance with established industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device requiring human adjudication or ground truth establishment based on expert consensus for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The SDS1.2 dental implant system is a physical medical device, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The SDS1.2 dental implant system is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established through adherence to recognized international standards and validated laboratory test methods. This includes:
- Biocompatibility testing (ISO 10993 series)
- Mechanical performance testing (e.g., fatigue testing per ISO 14801)
- Material standards compliance (e.g., ISO 13356 for Y-TZP)
- Sterilization and packaging validation standards (ISO 11137, ISO 11607)
- Comparison to technological characteristics of predicate devices that have already demonstrated safety and effectiveness.
8. The sample size for the training set
Not applicable. As a physical medical device, there is no "training set" in the context of AI/ML or statistical model development. The design and manufacturing processes are validated, and the device's performance is confirmed through non-clinical testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical medical device.
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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.
November 20, 2019
SDS Swiss Dental Solutions AG Martin Chares CTO Konstanzerstrasse 11 Kreuzlingen, 8280 SWITZERLAND
Re: K181953
Trade/Device Name: SDS1.2 dental implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 18, 2019 Received: October 22, 2019
Dear Martin Chares:
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 (OS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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.
for
Srinivas Nandkumar, Ph.D. Acting 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) K181953
Device Name SDS1.2 dental implant
Indications for Use (Describe)
SDS 1.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. SDS1.2_33xx implants are recommended as single-tooth implant for upper lateral and lower incisors for fixed prosthetic restorations only.
SDS 1.2 healing caps-disc, SDS .2 temporary caps and SDS 1.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS1.2 dental implant and enable the production/ fixation of long-term temporary restorations or protect the implant during healing phase for up to 180 days.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) number: K181953
1. Submitters contact information:
SDS Swiss Dental Solutions AG Konstanzerstrasse 11 82830 Kreuzlingen Switzerland
| Phone: | +41 71 556 3670 |
|---|---|
| Fax: | +41 71 556 3679 |
| Contact person: | Dr. Martin Chares |
| Date prepared: | 11-20-2019 |
2. Device name and classification
| Trade Name: | SDS1.2 dental implant |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant |
| Primary Product Code: | DZE |
| Secondary Product Code: | NHA |
| Regulation Number: | 21 CFR 872.3640 |
| Classification: | Class II |
3. Predicate devices
3.1 Primary Predicate Device SDS1.2 Dental implant
| Device Owner/Trade Name | 510(k) # | Product Code | |
|---|---|---|---|
| PrimaryPredicate Device | TAV Medical Ltd./W Zirconia Implants | K172668 | DZE (Implant, Endosseous,Root-Form) & NHA (EndosseousDental Implant Abutment) |
3.2 Reference Devices SDS1.2 Dental implant
| Device Owner/Trade Name | 510(k) # | Product Code | |
|---|---|---|---|
| ReferenceDevice | Oral Iceberg S.L./CeraRoot Implantsystem | K093595 | DZE (Implant, Endosseous,Root-Form) |
| ReferenceDevice | Z-Systems AG/Z-Look 3 | K062542 | DZE (Implant, Endosseous,Root-Form) |
| ReferenceDevice | Straumann USA LLCStraumann® PURECeramic Implants | K171769 | DZE (Implant, Endosseous,Root-Form) & NHA (EndosseousDental Implant Abutment) |
| ReferenceDevice | Prismatik Dentalcraft,INC.Hahn Tapered ImplantSystem | K143353 | DZE (Implant, Endosseous, Root-Form) |
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3.3 Primary Predicate Device SDS1.2 Temporary cap
| Device Owner/Trade Name | 510(k) # | Product Code | |
|---|---|---|---|
| PrimaryPredicate Device | TAV Medical Ltd./Temporary cap | K172668 | NHA (Endosseous DentalImplant Abutment) |
3.4 Primary Predicate Device SDS1.2 Healing cap-disc
| Device Owner/Trade Name | 510(k) # | Product Code | |
|---|---|---|---|
| PrimaryPredicate Device | TAV Medical Ltd./PEEK Healing cap for WOne Piece Zirconia Implant | K172668 | NHA (Endosseous DentalImplant Abutment) |
4. Device Description
4.1 SDS1.2 root-form endosseous dental implant
SDS1.2 dental implants are a one-piece implant system to fit a synthetic root replacement into the human jaw.
The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356.
The SDS1.2 dental implants are used to fix the prosthetic restoration and are suitable for patients with an intolerance to metal.
The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS1.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined.
SDS1.2 implants are provided in different length/ diameter combinations:
| Length | Apical diameter | Coronal diameter |
|---|---|---|
| 8 mm | 3.8 mm | 5.0 mm |
| 4.6mm | 6.0 mm | |
| 11 mm | 3.25 mm | 4.2 mm |
| 3.8 mm | 5.0 mm | |
| 4.6 mm | 6.0 mm | |
| 5.4 mm | 6.0 mm | |
| 14 mm | 3.25 mm | 4.2 mm |
| 3.8 mm | 5.0 mm | |
| 4.6 mm | 6.0 mm | |
| 5.4 mm | 6.0 mm |
Please note, that the SDS1.2 33xx implant body measures at Ø 3.25 mm.
SDS1.2 implants are provided with 2 different shoulder designs. These different designs allow for insertion in interdental gaps of different dimensions. The same surgical technique is used for both implant shoulder designs.
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The implants are provided sterile in sterile packaging and are intended for single use. SDS1.2 dental implants must not be re-sterilized or disinfected either.
When delivered, all SDS1.2 dental implants are mounted with the disposable SDS1.2 insertion tool which allows to remove the dental implant from the sterile packaging without touching it and then insert it into the prepared drill hole.
4.2 SDS 1.2 Temporary cap
Temporary restorations can be produced either individually or by using the prefabricated SDS1.2 Temporary cap as basis.
The SDS1.2 Temporary caps are made of PEEK (polyether ether ketone).
The SDS1.2 Temporary cap may only be used for screw-retaining temporary restorations with SDS1.2 standard screw (SDS1.2_SS-T) and must not be cemented.
The SDS1.2 Temporary caps are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ.
4.3 SDS1.2 Healing cap-disc
SDS1.2 Healing caps-disc may be used to protect the dental implant.
The Healing caps-disc are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356.
They can be fixed by screw-retaining with SDS1.2 standard titanium screws.
The SDS1.2 Healing caps-disc are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ.
| Subject device K181953 | Primary predicate device K172668 |
|---|---|
| Indications for Use SDS1.2 dental implants are intended as artificial replace-ments to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. SDS1.2_33xx implants are recommended as single-tooth implant for upper lateral and lower incisors for fixed prosthetic restorations only. | TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading |
5. Indications for use
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| SDS | SWISS DENTALSOLUTIONS |
|---|---|
| ----- | --------------------------- |
| SDS1.2healingcaps-disc, |
|---|
| SDS1.2temporarycaps and |
| SDS1.2 standard screws are |
| industriallymanufactured |
| prosthetic components. |
| They are connected to the SDS1.2 |
| dental implant and enable the |
| production/ fixation of long-term |
| temporary restorations or protect |
| the implant during the healing |
| phase for up to 180 days. |
The Indications for Use of the subject device is the same as the primary predicate device, and therefore contained within those indications, but also has the following additional differences as further discussed below.
- . The Indications for Use of the subject device also contains a limitation for the use of the smallest diameter implant body and a statement about the abutment components. As the primary predicate device's smallest implant diameter is 4.1 mm, the limitation for the use of the smallest diameter implant body of the subject device is equivalent to the limitation of the reference device K062542, with a diameter 3.25 mm to bridge this difference.
- . The addition of the healing caps and temporary caps have been added to the Indications for Use for the subject device, as these components can be used during the healing process to protect the implant or to enable the production/ fixation of longterm temporary restorations. The use of these components with the subject device are consistent with the use of similar components of the primary predicate device and therefore do not raise new questions of safety and effectiveness when compared to the predicate device.
The following reference devices were also used in this premarket notification to capture those technological characteristics found in the subject device that were not present in the primary predicate device and compares them in a side-by-side manner. These minor differences in technological characteristics as identified in the table below do not raise any new questions of safety and effectiveness between the subject and primary predicate device, as these differences are present in the reference devices, which have undergone FDA review and are legally marketed in the US.
| Manu-facturer: | SDS SwissDentalSolutions AG(K181953)SubjectDevice | TAV MedicalLtd.(K172668)PrimaryPredicateDevice | Oral IcebergS. L.(K093595)ReferenceDevice | Z-SystemsAG(K062542)ReferenceDevice | StraumannUSA LLC(K171769)ReferenceDevice | PrismatikDentalcraftInc.(K143353)ReferenceDevice |
|---|---|---|---|---|---|---|
| Trade Name | SDS1.2 dentalimplant | W ZirconiaImplants | CeraRootImplant system | Z-Look 3 | Straumann®PURE Ceramic | Hahn TaperedImplantSystem |
6. Technological characteristics
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Image /page/7/Picture/1 description: The image contains the logo for Swiss Dental Solutions. On the left side of the image, the letters "SDS" are written in a bold, sans-serif font. To the right of the letters, the words "SWISS DENTAL SOLUTIONS" are written in a smaller, sans-serif font. The words are stacked on top of each other.
| ImplantMonotype | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Material | Y-TZP | Y-TZP | Y-TZP | Y-TZP | Y-TZP | Ti6Al4 ELI | ||||||
| Manu-facturingTechnology | Turning | CIM | Turning | Turning | CIM | Standardmanufacturing | ||||||
| ImplantLength | 8.0 mm11.0 mm14.0 mm | 8.0 mm10.0 mm12.0 mm | 8.0 mm10.0 mm12.0 mm14.0 mm | 10.0 mm11.5 mm13.0 mm14.0 mm | 8.0 mm10.0 mm12.0 mm14.0 mm | 8.0 mm10.0 mm11.5 mm13.0 mm16.0 mm | ||||||
| ImplantDiameter(coronal) | 4.2 mm5.0 mm6.0 mm | 4.1 mm4.8 mm | 3.5 mm4.1 mm4.8 mm6.0 mm6.5 mm | 4.1 mm5.2 mm6.0 mm | 3.5 mm4.8 mm | 3.0 mm3.5 mm4.3 mm5.0 mm7.0 mm | ||||||
| Abutmentpost height | 4 mm | 5 mm | 3 mm, limiteduse4.8 mm5.0 mm6.3 mm | 5 mm | 4 mm5.5 mm | not-stated | ||||||
| Types | Length/mm | Dia-meter/mm | Length/mm | Dia-meter/mm | Length/mm | Dia-meter/mm | Length/mm | Dia-meter/mm | Length/mm | Dia-meter/mm | Length/mm | Dia-meter/mm |
| 8 | 5.06.0 | 8 | 4.14.8 | 8 | 4.8 | 10 | 3.254.0 | 8 | 3.54.8 | 8 | 3.54.3 | |
| 4.5 | 5.07.0 | |||||||||||
| 11 | 4.25.06.0 | 10 | 4.14.8 | 10 | 4.14.86.06.5 | 11.5 | 3.254.0 | 10 | 3.54.8 | 10 | 3.54.35.07.0 | |
| 14 | 4.25.06.0 | 12 | 4.14.8 | 12 | 4.14.86.06.5 | 13.0 | 3.25 | 12 | 3.54.8 | 11.5 | 3.03.54.35.07.0 | |
| 14 | 4.14.86.06.5 | 14.0 | 5.0 | 14 | 3.54.8 | 13 | 3.03.54.35.0 | |||||
| 16 | 3.03.54.35.0 | |||||||||||
| Angulation/Divergence | Possible upto 20° | 0° for one-piece zirconiaimplant | 0° | Possible upto 20° | 0° | 0° — 30° | ||||||
| Design | One-Piece | One-Piece/Two-Piece | One-Piece | One-Piece | One-Piece | Two-Piece | ||||||
| Shoulderdesign | StandardshoulderOval shoulder | Standardshoulder | Standardshoulder | Standardshoulder | StandardShoulder | StandardShoulder | ||||||
| ImplantSurfaceTreatment | Sand blasted | no additionaltreatment | ICE® surface | Grit blasted | no additionaltreatment | Blasted withHydroxylApatit | ||||||
| SurfaceTopography | Roughness | Roughness | Roughness | Roughness | Roughness | RBM SurfaceTechnology |
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Image /page/8/Picture/1 description: The image shows the logo for SDS, which is a company that specializes in software and services. The logo is composed of the letters "SDS" in a bold, sans-serif font, followed by the words "SOFTWARE & SERVICES" in a smaller, lighter font. The logo is simple and modern, and it is likely to be easily recognizable.
| Sterilization | Sterilized by Radiation | Sterilized by Radiation | Sterilization by ethylene oxide | Steam sterilization | Sterilization by ethylene oxide | Sterilization by Gamma irradiation |
|---|---|---|---|---|---|---|
| Intended Use Environment | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting | Dental Clinic Setting |
7. Substantial Equivalence Discussion
7.1 Substantial Equivalence Discussion SDS1.2 Dental implants
As demonstrated in the substantial equivalence discussion the SDS1.2 subject device is equivalent to the selected predicate devices.
The subject device is like the predicate devices in terms of intended use, technological characteristics, packaging, sterilization and design key elements (included implant surface topography, design, etc.).
Certain differences can be covered by reference devices.
In terms of diameter and length there is a difference between the subject device K181953 and the primary predicate device. However, the reference devices K093595, K143353 and K171769 include implants with a similar range of combinations including smallest and largest length with smallest and largest diameter.
In terms of angulation there is a difference between the subject device and the primary predicate device. However, the reference device K062542 allows equivalent angulation application as the subject device.
In terms of packaging the subject and predicate devices are sterile packed, the subject device is in a sealed blister while the primary predicate device is in a sealed tube. The subject device and the reference device K143353 are packaged in a single sealed tray. Both the proposed and primary predicate device are sterilized using Gamma irradiation. The effectiveness of the packaging and sterilization process is verified by a packaging and sterilization. A sterility assurance level of <10 %(SAL) is achieved for both devices, therefore the SDS1.2 dental implant is substantially equivalent to the primary predicate device and the reference device for a single tray packaging system.
Based on the comparison it can be concluded, that the SDS1.2 dental implants are substantially equivalent to the predicate devices listed.
7.2 Substantial Equivalence Discussion SDS1.2 Temporary cap
The minor differences in the products diameter do not raise any performance differences due to the similarity of SDS1.2 temporary cap to its predicate device design and range. Therefore, it may be concluded that SDS1.2 temporary cap for SDS1.2 dental implants and its predicate share the same intended use and technological characteristics and therefore are substantially equivalent.
7.3 Substantial Equivalence Discussion SDS1.2 Healing cap-disc
SDS1.2 healing-caps disc are substantially equivalent in terms of intended use, indications for use, geometry and fixation on implant to the predicate PEEK Healing Cap for W One Piece Zirconia Implant. The different material does not represent a restriction. TZP-A used for the SDS1.2 healing cap-disc, is well established in the dental implant market and does not affect
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the performance or biocompatibility of the product. This material is also used for the implants itself.
8. Non clinical testing
8.1 Biocompatibility
Concerning biocompatibility, the components of the SDS1.2 dental implant system described in the biocompatibility document were subjected to a biological evaluation according to ISO 10993-1 including cytotoxicity tests according to ISO 10993-5.
For the manufacturing of SDS1.2 dental implant system, identical materials are used in comparable reference devices with the same type and duration of patient contact (see also substantial equivalence comparison).
Concerning the residues from manufacturing processes, the biocompatibility is demonstrated by the tests regarding Cytotoxicity. Bioburden and Endotoxins by an accredited laboratory.
The methods applied for manufacturing, cleaning and sterilization are established validated procedures since several years.
8.2 Performance testing
Performance testing of SDS1.2 dental implant system was planned regarding the risk analysis acc. ISO 14971.
As a result of the risk analysis and regarding the applicable FDA guidance, testing concerning stability, surface structure analysis and several laboratory tests were identified as essential.
In particular; fatigue testing in accordance with ISO 14801 and surface investigation with the aid of the scanning electron microscope and laboratory testing regarding the presence of extractable cytotoxic substances, pyrogenicity and total orqanic carbon have been planned and performed as recommended by the FDA Guidance Document "Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile".
The testing results were analyzed and evaluated. They demonstrate, that the SDS1.2 Dental implants meet the existing requirements and acceptance criteria like the predicate devices.
8.3 Sterilization validation and shelf life
To ensure the sterility of SDS1.2 Dental implants, the sterilization was conducted in compliance with ISO 11137-2.
The validation results have proved a minimal sterilization dose of 25 Gv that leads to a sterility assurance level of ≤ 10° as required by DIN EN 556-1 for sterile medical devices.
For the packaging system a performance validation acc. to ISO 11607-1 and ISO 11607-2 was completed.
The validation results have demonstrated that the packaging system of the SDS1.2 Dental implants fulfilled the requirements regarding the packaging performance during sterilization and storage till 5 years accelerated aging.
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For the products provided non-sterile, the validation of end-user sterilization has been performed according to ISO 17665-1.
The validation results have demonstrated, that the stated cleaning, disinfection and sterilization process meet the defined results.
9. Animal testing
Not applicable
10. Clinical testing
Not applicable, SDS1.2 Dental implant does not meet one of the characteristics defined by FDA for which clinical studies are needed
11. Applicable standards
SDS 1.2 Dental implants meet all requirements of the applicable standards listed in the table below.
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Image /page/11/Picture/1 description: The image shows the logo for Swiss Dental Solutions (SDS). The letters "SDS" are in bold, black font on the left side of the image. To the right of "SDS" are the words "SWISS DENTAL" on the top line and "SOLUTIONS" on the bottom line, also in black font.
| Standard | Title |
|---|---|
| ISO 14801 Secondedition 2007-11-15 | Dentistry-Implants-Dynamic fatigue test for endosseous dentalimplants |
| ISO 7405 Secondedition 2008-12-15 | Dentistry - Evaluation of biocompatibility of medical devicesused in dentistry [Including: Amendment 1 (2013)] |
| ISO 5832-2:1999 | Implants for surgery -- Metallic materials - Part 2: Unalloyed ISO5832-3 Fourth edition 2016-10-15 titanium |
| ISO 13356 | Implants for surgery - Ceramic materials based on yttria -stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015);German version EN ISO 13356:2015 |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process |
| ISO 14971 | Medical devices - Application of risk management to medicaldevices |
| ISO 15223-1 | Medical devices - Symbols to be used with medical devicelabels, labelling and information to be supplied - Part 1: Generalrequirements |
| ISO 11607-1 | Packaging for terminally sterilized medical devices – Part 1:Requirements for materials, sterile barrier systems andpackaging systems (ISO 11607-1:2006 + AMD 1.:2014) |
| ISO 11607-2 | Packaging for terminally sterilized medical devices – Part 2:Validation requirements for forming, sealing and assemblyprocesses (ISO/ DIS 11607-2:2017) |
| ISO 11137-1 | Sterilization of health care products - Radiation – Part 1:Requirements for development, validation and routine control ofa sterilization process for medical devices (ISO 11137-1:2006,including AMD 1:2013); German version EN ISO 11137-1:2015 |
| ISO 11137-2 | Sterilization of health care products – Radiation – Part 2:Establishing the sterilization dose |
12. Summary
Based on the results of Substantial Equivalence Discussion, Performance testing results and the compliance with applicable standards, the SDS1.2 dental implant system with the included components is considered substantially equivalent to the named predicate devices. Existing minor differences in design and technology between the subject device and the predicate devices do not raise any new questions of safety and effectiveness. Therefore, it can be concluded that the SDS1.2 dental implant system is substantially equivalent to the predicate devices.
§ 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.