(364 days)
No
The device description and performance studies focus on the material properties, mechanical performance, and biological compatibility of the dental implants and associated components. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device, SDS2.2 dental implants, is intended to provide "anchor points for the prosthetic restoration" in the human jaw, which serves as a treatment to replace missing teeth and restore oral function.
No
The device description indicates that the SDS2.2 dental implants are "artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration." This describes a therapeutic or reconstructive device, not one designed to diagnose a condition or disease.
No
The device description clearly details physical components made of materials like Y-TZP and PEEK, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "artificial replacement to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration." This describes a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics, materials, and components of a dental implant system designed for surgical implantation and prosthetic attachment. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely mechanical and structural within the human body.
Therefore, the SDS2.2 dental implant system falls under the category of a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SDS2.2 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.
SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
SDS2.2 dental implants are a two-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 SDS2.2 dental implant system with its included components is used to fix the prosthetic restoration and is 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 SDS2.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined.
SDS2.2 implants are provided in different length/ diameter combinations:
Length: 8 mm, 11 mm, 14 mm
Apical diameter: 3.8 mm, 4.6mm, 5.4 mm
Coronal diameter: 5.0 mm, 6.0 mm
SDS2.2 implants are provided with 2 different shoulder designs, available in either standard shoulder and oval shoulder. These different designs allow for insertion in interdental gaps of different dimensions. The same surgical technique is used for both implant shoulder designs.
The implants are provided sterile in sterile packaging and are intended for single use. SDS2.2 dental implants must not be re-sterilized or disinfected either.
The sterile packaging also includes the SDS2.2 cover screw made of PEEK (Polyetheretherketone), which can be used to protect the implant interface during the healing phase up to 180 days.
SDS2.2 cover screw is intended for single-use and must not be re-sterilized or disinfected either.
SDS2.2 standard implant posts are made of Y-TZP and are attached to SDS 2.2 dental implants by cementation. During cementation, the implant posts are screw retained with the SDS2.2 standard PEEK screw to ensure implant post is fixed at final position. The SDS2.2 standard PEEK screw is removed before the cement is completely cured.
After attachment to the SDS2.2 implant, standard implant posts enable cementation of prosthetic restorations.
SDS2.2 standard implant posts are available in different designs:
SDS2.2_AB-S+1.5: Diameter 4.1 mm, Post height 4.9 mm, Angulation None
SDS_AB-S15°: Diameter 4.1 mm, Post height 7.0 mm, Angulation 15°
The SDS2.2 standard implant posts and SDS2.2 standard PEEK screws are provided nonsterile. They are intended for single use and must not be reused. Before use they must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for the use of SDS2.2 implant posts/ standard screws" document.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) / Dental Clinic Setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of SDS2.2 dental implant system was planned regarding the risk analysis acc. ISO 14971.
The indicated performance tests were derived and have been projected.
As a result of the risk analysis and regarding the applicable FDA guidance, testing concerning stability, surface structure analysis and several laboratory testing were identified as essential.
In particular, fatigue testing acc. ISO 14801, surface investigation with the aid of the scanning electron microscope and laboratory testing regarding presence of extractable cytotoxic substances, pyrogenicity and total organic 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 SDS2.2 dental implant system meets the existing requirements and acceptance criteria like the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 20, 2020
SDS Swiss Dental Solutions AG Martin Chares CTO Konstanzerstrasse 11 Kreuzlingen, 8280 SWITZERLAND
Re: K190406
Trade/Device Name: SDS2.2 dental implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 17, 2020 Received: January 21, 2020
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190406
Device Name SDS2.2 dental implant
Indications for Use (Describe)
SDS2.2 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.
SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/2 description: The image contains the logo for Swiss Dental Solutions. The logo has the letters SDS in bold black font on the left. To the right of the letters are the words SWISS DENTAL on the top line and SOLUTIONS on the bottom line. The words SWISS DENTAL SOLUTIONS are in a smaller, thinner font than the letters SDS.
510(k) number: K190406
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: | 02-19-2020 |
2. Device name and classification
| Trade Name: | SDS2.2 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 SDS2.2 dental implant
| | Device Owner/
Trade Name | 510(k) # | Product Code |
|--------------------------------|-------------------------------------------------------------|----------|-----------------------------------------|
| Primary
Predicate
Device | SDS Swiss Dental
Solutions AG/ SDS1.2
dental implants | K181953 | DZE (Implant, Endosseous,
Root-Form) |
3.2 Reference devices SDS2.2 dental implant
| | Device Owner/
Trade Name | 510(k) # | Product Code |
|---------------------|---------------------------------------------------------|----------|-----------------------------------------|
| Reference
Device | TAV Medical Ltd./
W Zirconia Implants | K172668 | DZE (Implant, Endosseous,
Root-Form) |
| Reference
Device | Z-Systems AG
Z5c Dental Implant | K132881 | DZE (Implant, Endosseous,
Root-Form) |
| Reference
Device | Dental Point AG
Zeramex® P6 Dental
Implant System | K163043 | DZE (Implant, Endosseous,
Root-Form) |
4
3.3 Reference Devices SDS2.2 implant post
| | Device Owner/
Trade Name | 510(k) # | Product Code |
|---------------------|-----------------------------------------|----------|---------------------------------------------|
| Reference
Device | Z-Systems AG
Z5c Abutment | K132881 | NHA (Endosseous Dental
Implant Abutment) |
| Reference
Device | TAV Medical Ltd.
Titanium Abutment | K172668 | NHA (Endosseous Dental
Implant Abutment) |
| Reference
Device | Dental Point AG
Zeramex® P6 Abutment | K163043 | NHA (Endosseous Dental
Implant Abutment) |
4. Device description
4.1 SDS2.2 dental implant
SDS2.2 dental implants are a two-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 SDS2.2 dental implant system with its included components is used to fix the prosthetic restoration and is 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 SDS2.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined.
| Length | Apical diameter | Coronal diameter |
|---|---|---|
| 8 mm | 3.8 mm | 5.0 mm |
| 4.6mm | 6.0 mm | |
| 11 mm | 3.8 mm | 5.0 mm |
| 4.6 mm | 6.0 mm | |
| 5.4 mm | 6.0 mm | |
| 14 mm | 3.8 mm | 5.0 mm |
| 4.6 mm | 6.0 mm | |
| 5.4 mm | 6.0 mm |
SDS2.2 implants are provided in different length/ diameter combinations:
SDS2.2 implants are provided with 2 different shoulder designs, available in either standard shoulder and oval shoulder. These different designs allow for insertion in interdental gaps of different dimensions. The same surgical technique is used for both implant shoulder designs.
The implants are provided sterile in sterile packaging and are intended for single use. SDS2.2 dental implants must not be re-sterilized or disinfected either.
The sterile packaging also includes the SDS2.2 cover screw made of PEEK
(Polyetheretherketone), which can be used to protect the implant interface during the healing phase up to 180 days.
SDS2.2 cover screw is intended for single-use and must not be re-sterilized or disinfected either.
5
Image /page/5/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 the letters, the words "SWISS DENTAL SOLUTIONS" are written in a smaller, thinner font. The words "SWISS DENTAL" are stacked on top of the word "SOLUTIONS".
4.2 SDS 2.2 standard implant post/ SDS2.2 standard PEEK screw
SDS2.2 standard implant posts are made of Y-TZP and are attached to SDS 2.2 dental implants by cementation. During cementation, the implant posts are screw retained with the SDS2.2 standard PEEK screw to ensure implant post is fixed at final position. The SDS2.2 standard PEEK screw is removed before the cement is completely cured.
After attachment to the SDS2.2 implant, standard implant posts enable cementation of prosthetic restorations.
SDS2.2 standard implant posts are available in different designs:
| SDS2.2_AB-S+1.5 | SDS_AB-S15° | |
|---|---|---|
| Diameter | 4.1 mm | 4.1 mm |
| Post height | 4.9 mm | 7.0 mm |
| Angulation | None | 15° |
The SDS2.2 standard implant posts and SDS2.2 standard PEEK screws are provided nonsterile. They are intended for single use and must not be reused. Before use they must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for the use of SDS2.2 implant posts/ standard screws" document.
5. Indications for use
| Subject device K190406 | Primary predicate device K181953 | |
|---|---|---|
| Indications | ||
| for Use | SDS2.2 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. |
SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations. | SDS1.2 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.
SDS1.2 healing caps-disc, SDS1.2 temporary caps and SDS1.2 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 the healing phase for up to 180 days. |
6
510(k) summary
Image /page/6/Picture/1 description: The image contains the logo for SDS Swiss Dental Solutions. The logo is composed of two parts. The first part is the acronym "SDS" in bold, sans-serif font. The second part is the text "SWISS DENTAL SOLUTIONS" in a smaller, sans-serif font. The text is aligned to the right of the acronym.
The Indications for Use of the subject device are the same as of the primary predicate device with only some minor differences as further discussed below.
- . The Indications for Use of the primary predicate device contains a limitation for the use of the smallest diameter implant body and a statement about further components. As the subject device's smallest implant diameter is 5.0 mm, the limitation for the use of the smallest diameter implant body of the primary predicate device is not applicable to the subject device.
- . The prosthetic components are different due to the Two-piece design of the subject device compared to the One-piece design of the primary predicate device. 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.
Below reference devices were also used in this premarket notification to capture technological characteristics found in the subject device that were not present in the primary predicate device (due to its One-piece design). 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 Swiss
Dental
Solutions AG
(K190406)
Subject Device | SDS Swiss
Dental
Solutions AG
(K181953)
Primary Predicate Device | TAV Medical
Ltd.
(K172668)
Reference Device | Z-Systems AG
(K132881)
Reference Device | Dentalpoint
AG
(K163043)
Reference Device | | | | | |
|----------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------|----------------------------------------------------|------------|---------------|------------|---------------|-------------------|
| Trade Name | SDS2.2 dental
implant | SDS1.2 dental
implant | W Zirconia
Implants | Z5c | Zeramex® P6 | | | | | |
| Material | Y-TZP | Y-TZP | Y-TZP | Y-TZP | ZrO2-ATZ-HIP | | | | | |
| Manu-
facturing
Technology | Turning | Turning | CIM: Ceramic
injection molding | Turning | Turning | | | | | |
| Implant
Length | 8.0 mm
11.0 mm
14.0 mm | 8.0 mm
11.0 mm
14.0 mm | 8.0 mm
10.0 mm
12.0 mm | 8.0 mm
10.0 mm
12.0 mm | 8.0 mm
10.0 mm
12.0 mm
14.0 mm | | | | | |
| Implant
Diameter
(coronal) | 5.0 mm
6.0 mm | 4.2 mm
5.0 mm
6.0 mm | 4.1 mm
4.8 mm | 5.0 mm
6.0 mm | 3.3 mm
4.1 mm
4.8 mm | | | | | |
| Types | Length/
mm | Ø/ mm | Length/
mm | Ø/ mm | Length/
mm | Ø/ mm | Length/
mm | Ø/ mm | Length/
mm | Ø/ mm |
| | 8 | 5.0
6.0 | 8 | 5.0
6.0 | 8 | 4.1
4.8 | 8 | 4.0
5.0 | 8 | 3.3
4.1
4.8 |
| | 11 | 5.0
6.0 | 11 | 4.2
5.0
6.0 | 10 | 4.1
4.8 | 10 | 4.0
5.0 | 10 | 3.3
4.1
4.8 |
| | 14 | 5.0
6.0 | 14 | 4.2
5.0
6.0 | 12 | 4.1
4.8 | 12 | 4.0
5.0 | 12 | 3.3
4.1
4.8 |
6. Technological characteristics
7
510(k) summary
Image /page/7/Picture/1 description: The image shows the logo for SDS Swiss Digital Solutions. The letters "SDS" are in bold, black font on the left side of the image. To the right of the letters, the words "SWISS DIGITAL SOLUTIONS" are written in a smaller, lighter font.
| | | | | | | | | | 14 | 3.3
4.1
4.8 |
|---------------------------------|---------------------------------------------------------------------------------|--|---------------------------------------|--|-----------------------------|--|------------------------------------|--|---------------------------------------|-------------------|
| Angulation/
Divergence | Possible up
to 15° when using
the standard
implant post
SDS AB-S15° | | Possible up
to 20° | | no information
available | | no information
available | | no information
available | |
| Design | Two-piece | | One-Piece | | One-Piece/
Two-Piece | | Two-Piece | | Two-piece | |
| Shoulder
design | Standard
shoulder
Oval shoulder | | Standard
shoulder
Oval shoulder | | Standard
shoulder | | Standard
shoulder | | Standard
shoulder | |
| Implant
Surface
Treatment | Sand blasted | | Sand blasted | | no additional
treatment | | Grit blasted and
laser modified | | ZERAFIL™
sandblasted and
etched | |
| Surface
Topography | Roughness | | Roughness | | Roughness | | Roughness | | Roughness | |
| Sterilization | Sterilized by
Radiation | | Sterilized by
Radiation | | Sterilized by
Radiation | | Plasma
sterilization | | Steam
sterilization | |
| Intended
Use
Environmen | Dental Clinic
Setting | | Dental Clinic
Setting | | Dental Clinic
Setting | | Dental Clinic
Setting | | Dental Clinic
Setting | |
7. Substantial equivalence discussion
7.1 Substantial equivalence discussion SDS2.2 dental implants
As demonstrated in the substantial equivalence discussion the SDS2.2 subject device is equivalent to the selected predicate devices.
The subject device is equivalent to the primary predicate device in terms of intended use, technological characteristics, material and design key elements (including diameter and length, production technology, implant surface topography, sterile packaging, shoulder design, etc.).
Certain differences from the primary predicate device are covered by the reference devices as follows:
- In terms of anti-rotation protection, the subject device is designed with an internal ● hexagon, while the primary predicate device features a One-Piece design. This difference is covered by the reference devices K172668 and K163043. which are also providing an internal hexagon for anti-rotation protection.
- Regarding available abutments, the primary predicate device features a One-Piece . design that requires no additional abutments. This difference is covered by the reference devices K132881, K172668 and K163043, which are containing abutments in similar designs.
Based on this comparison it can be concluded, that the subject device K190406 is substantially equivalent to the predicate devices listed.
8
7.2 Substantial equivalence discussion SDS2.2 standard implant posts
As demonstrated in the substantial equivalence discussion the SDS2.2 subject device is equivalent to the selected predicate devices.
SDS2.2 standard implant posts are substantially equivalent in terms of material, intended use, indications for use and geometry to the reference devices listed above.
Certain differences from the reference devices are covered by following facts:
- In terms of length, SDS2.2 standard implant posts are available in a greater length . compared to the reference devices. This difference in product height does not raise any performance differences due to the similarity of the subject device to the reference devices K172668 and K163043. Additionally, the increased product height of the SDS2.2 angulated standard implant post has been tested successfully in the context of performed fatique testing according to ISO 14801.
- Regarding the connection of the abutment to the implant, for the subject device the . fixation of the standard implant post during cementation by screw retaining is mandatory while the reference device K132881 does not require screw retaining during this process. This difference is bridged by the reference device K163043, which uses a PEEK screw for retaining of the abutment on the one hand and the fact, that the screw of the subject device is removed before the cement is completely cured on the other hand.
- Regarding the cements used for bonding, SDS2.2 implant posts are recommended to . be bonded using the dental cement Ketac™Cem Automix, whereas the reference devices recommend Panavia™ SA Cement Automix and RelyX™ Luting Plus Automix. The difference is bridged by the fact, that all stated dental cements are cleared medical devices, cleared under K032455, K111185 and K002793.
- . Additionally, the dental cement Ketac™Cem Automix (K002793) has been tested successfully in the context of performed fatigue testing according to ISO 14801.
Based on this comparison it can be concluded, that the subject device is substantially equivalent to the reference devices listed.
8. Non clinical testing
8.1 Biocompatibility
Concerning biocompatibility, the components of the SDS2.2 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 SDS2.2 dental implant system, identical materials are used in the primary predicate 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 and are identical to the methods applied for the primary predicate device, cleared under K181953.
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8.2 Performance testing
Performance testing of SDS2.2 dental implant system was planned regarding the risk analysis acc. ISO 14971.
The indicated performance tests were derived and have been projected.
As a result of the risk analysis and regarding the applicable FDA guidance, testing concerning stability, surface structure analysis and several laboratory testing were identified as essential.
In particular, fatigue testing acc. ISO 14801, surface investigation with the aid of the scanning electron microscope and laboratory testing regarding presence of extractable cytotoxic substances, pyrogenicity and total organic 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 SDS2.2 dental implant system meets the existing requirements and acceptance criteria like the predicate devices.
8.3 Sterilization validation and shelf life
To ensure the sterility of SDS2.2 dental implants, the sterilization was conducted in compliance with ISO 11137-2.
The validation results have proved a minimal sterilization dose of 25 Gy that leads to a sterility assurance level of ≤ 10- as required by ISO 11137-1 and ISO 11137-2 for sterile medical devices.
For the packaging system a performance validation acc. to ISO 11607-2 was completed.
The validation results have demonstrated that the packaging system of the SDS2.2 dental implants fulfilled the requirements regarding the packaging performance during sterilization and storage till 5 years accelerated aging.
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, bench testing is performed
10. Clinical testing
Not applicable, SDS2.2 dental implant system does not meet one of the characteristics defined by FDA for which clinical studies are needed
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SDS 2.2 dental implants meet all requirements of the applicable standards listed in the table.
| Standard | Title |
|---|---|
| ISO 14801 Second | |
| edition 2007-11-15 | Dentistry-Implants-Dynamic fatigue test for endosseous dental |
| implants | |
| ISO 7405 Second | |
| edition 2008-12-15 | Dentistry - Evaluation of biocompatibility of medical devices |
| used in dentistry [Including: Amendment 1 (2013)] | |
| ISO 5832-2:1999 | Implants for surgery -- Metallic materials - Part 2: Unalloyed ISO |
| 5832-3 Fourth edition 2016-10-15titanium | |
| ISO 13356 | Implants for surgery - Ceramic materials based on yttria- |
| stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015); | |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and |
| testing within a risk management process | |
| ISO 14971 | Medical devices - Application of risk management to medical devices |
| ISO 15223-1 | Medical devices - Symbols to be used with medical device |
| labels, labelling and information to be supplied - Part 1: General | |
| requirements | |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: |
| Requirements for materials, sterile barrier systems and | |
| packaging 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 assembly | |
| processes (ISO/ DIS 11607-2:2017) | |
| ISO 11137-1 | Sterilization of health care products - Radiation - Part 1: |
| Requirements for development, validation and routine control of | |
| a sterilization process for medical devices (ISO 11137-1:2006, | |
| including AMD 1:2013) | |
| 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 SDS2.2 dental implant system with the included components are 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 SDS2.2 dental implant system is substantially equivalent to the predicate devices.