Who is the manufacturer of SDS1.2 dental implant?

Sds Swiss Dental Solutions AG filed the 510(k) submission for SDS1.2 dental implant (K181953).

What is the FDA product code for SDS1.2 dental implant?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for SDS1.2 dental implant?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SDS1.2 dental implant?

TAV Medical Ltd./ W Zirconia Implants (K172668); TAV Medical Ltd./ Temporary cap (K172668); TAV Medical Ltd./ PEEK Healing cap for W One Piece Zirconia Implant (K172668).

Who can help prepare an FDA 510(k) submission like SDS1.2 dental implant?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SDS1.2 dental implant

K181953 · Sds Swiss Dental Solutions AG · DZE · Nov 20, 2019 · Dental

Device Facts

Record ID	K181953
Device Name	SDS1.2 dental implant
Applicant	Sds Swiss Dental Solutions AG
Product Code	DZE · Dental
Decision Date	Nov 20, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

SDS1.2 dental implant system consists of one-piece Y-TZP zirconia ceramic implants, PEEK temporary caps, and healing caps-disc. Implants feature a self-tapping Dynamic Thread design with a bone-condensing section and micro-threaded upper section; surface is abrasive blasted for osseointegration. Used in dental clinics by clinicians to provide anchor points for prosthetic restorations. Implants are provided sterile; temporary/healing caps are provided non-sterile for end-user sterilization. Device is placed in the jaw to support fixed prosthetic restorations. Immediate loading is permitted if primary stability is achieved. Benefits include metal-free restoration option and support for immediate loading protocols.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included fatigue testing (ISO 14801), surface structure analysis (SEM), and biocompatibility testing (ISO 10993-1/5). Sterilization and packaging validated per ISO 11137-2 and ISO 11607-1/2.

Technological Characteristics

Materials: Y-TZP (ISO 13356) for implants/healing caps, PEEK for temporary caps. Design: One-piece, self-tapping Dynamic Thread, abrasive blasted surface. Dimensions: Lengths 8-14mm, diameters 3.25-6.0mm. Sterilization: Gamma irradiation (implants), end-user steam sterilization (caps).

Indications for Use

Indicated for patients requiring artificial tooth replacement in the upper or lower jaw. Suitable for patients with metal intolerance. SDS1.2_33xx implants are indicated for single-tooth replacement in upper lateral and lower incisors. Contraindicated for cases where primary stability cannot be achieved.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

TAV Medical Ltd./ W Zirconia Implants (K172668)
TAV Medical Ltd./ Temporary cap (K172668)
TAV Medical Ltd./ PEEK Healing cap for W One Piece Zirconia Implant (K172668)

Reference Devices

Oral Iceberg S.L./ CeraRoot Implant system (K093595)
Z-Systems AG/ Z-Look 3 (K062542)
Straumann USA LLC/ Straumann® PURE Ceramic Implants (K171769)
Prismatik Dentalcraft, INC./ Hahn Tapered Implant System (K143353)

Related Devices

K190406 — SDS2.2 dental implant · Sds Swiss Dental Solutions AG · Feb 20, 2020
K151328 — PURE Ceramic Implants · Straumann USA · Jan 11, 2016
K221488 — Z7 Zirconia Implant System · Z7, LLC · Jun 26, 2023
K192053 — W Zirconia Implants · Tav Medical , Ltd. · Oct 29, 2019
K170372 — SpiralTech Dental Implant System · Spiraltech Superior Dental Implants, Inc. · Jun 30, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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. {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. 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) 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 | |-----------------------------|------------------------------------------|----------|---------------------------------------------------------------------------------------| | Primary Predicate Device | TAV Medical Ltd./ W Zirconia Implants | K172668 | DZE (Implant, Endosseous, Root-Form) & NHA (Endosseous Dental Implant Abutment) | ## 3.2 Reference Devices SDS1.2 Dental implant | | Device Owner/ Trade Name | 510(k) # | Product Code | |---------------------|------------------------------------------------------------------|----------|---------------------------------------------------------------------------------------| | Reference Device | Oral Iceberg S.L./ CeraRoot Implant system | K093595 | DZE (Implant, Endosseous, Root-Form) | | Reference Device | Z-Systems AG/ Z-Look 3 | K062542 | DZE (Implant, Endosseous, Root-Form) | | Reference Device | Straumann USA LLC Straumann® PURE Ceramic Implants | K171769 | DZE (Implant, Endosseous, Root-Form) & NHA (Endosseous Dental Implant Abutment) | | Reference Device | Prismatik Dentalcraft, INC. Hahn Tapered Implant System | K143353 | DZE (Implant, Endosseous, Root- Form) | {4}------------------------------------------------ ## 3.3 Primary Predicate Device SDS1.2 Temporary cap | | Device Owner/ Trade Name | 510(k) # | Product Code | |-----------------------------|------------------------------------|----------|---------------------------------------------| | Primary Predicate Device | TAV Medical Ltd./ Temporary cap | K172668 | NHA (Endosseous Dental Implant Abutment) | #### 3.4 Primary Predicate Device SDS1.2 Healing cap-disc | | Device Owner/ Trade Name | 510(k) # | Product Code | |-----------------------------|---------------------------------------------------------------------------|----------|---------------------------------------------| | Primary Predicate Device | TAV Medical Ltd./ PEEK Healing cap for W One Piece Zirconia Implant | K172668 | NHA (Endosseous Dental Implant 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ | SDS | SWISS DENTAL SOLUTIONS | |-----|---------------------------| |-----|---------------------------| | 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. | 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 Swiss Dental Solutions AG (K181953) Subject Device | TAV Medical Ltd. (K172668) Primary Predicate Device | Oral Iceberg S. L. (K093595) Reference Device | Z-Systems AG (K062542) Reference Device | Straumann USA LLC (K171769) Reference Device | Prismatik Dentalcraft Inc. (K143353) Reference Device | |--------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------| | Trade Name | SDS1.2 dental implant | W Zirconia Implants | CeraRoot Implant system | Z-Look 3 | Straumann® PURE Ceramic | Hahn Tapered Implant System | # 6. Technological characteristics {7}------------------------------------------------ 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. | | | | | | | | | | Implant Monotype | | | | |----------------------------------|---------------------------------------|----------------------|------------------------------------------|----------------------|----------------------------------------------------|--------------------------|------------------------------------------|----------------------|-----------------------------------------|----------------------|----------------------------------------------------|---------------------------------| | Material | Y-TZP | | Y-TZP | | Y-TZP | | Y-TZP | | Y-TZP | | Ti6Al4 ELI | | | Manu- facturing Technology | Turning | | CIM | | Turning | | Turning | | CIM | | Standard manufacturing | | | Implant Length | 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 14.0 mm | | 10.0 mm 11.5 mm 13.0 mm 14.0 mm | | 8.0 mm 10.0 mm 12.0 mm 14.0 mm | | 8.0 mm 10.0 mm 11.5 mm 13.0 mm 16.0 mm | | | Implant Diameter (coronal) | 4.2 mm 5.0 mm 6.0 mm | | 4.1 mm 4.8 mm | | 3.5 mm 4.1 mm 4.8 mm 6.0 mm 6.5 mm | | 4.1 mm 5.2 mm 6.0 mm | | 3.5 mm 4.8 mm | | 3.0 mm 3.5 mm 4.3 mm 5.0 mm 7.0 mm | | | Abutment post height | 4 mm | | 5 mm | | 3 mm, limited use 4.8 mm 5.0 mm 6.3 mm | | 5 mm | | 4 mm 5.5 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 | 5.0 6.0 | 8 | 4.1 4.8 | 8 | 4.8 | 10 | 3.25 4.0 | 8 | 3.5 4.8 | 8 | 3.5 4.3 | | | | | | | | | | 4.5 | | | | 5.0 7.0 | | | 11 | 4.2 5.0 6.0 | 10 | 4.1 4.8 | 10 | 4.1 4.8 6.0 6.5 | 11.5 | 3.25 4.0 | 10 | 3.5 4.8 | 10 | 3.5 4.3 5.0 7.0 | | | 14 | 4.2 5.0 6.0 | 12 | 4.1 4.8 | 12 | 4.1 4.8 6.0 6.5 | 13.0 | 3.25 | 12 | 3.5 4.8 | 11.5 | 3.0 3.5 4.3 5.0 7.0 | | | | | | | 14 | 4.1 4.8 6.0 6.5 | 14.0 | 5.0 | 14 | 3.5 4.8 | 13 | 3.0 3.5 4.3 5.0 | | | | | | | | | | | | | 16 | 3.0 3.5 4.3 5.0 | | Angulation/ Divergence | Possible up to 20° | | 0° for one- piece zirconia implant | | 0° | | Possible up to 20° | | 0° | | 0° — 30° | | | Design | One-Piece | | One-Piece/ Two-Piece | | One-Piece | | One-Piece | | One-Piece | | Two-Piece | | | Shoulder design | Standard shoulder Oval shoulder | | Standard shoulder | | Standard shoulder | | Standard shoulder | | Standard Shoulder | | Standard Shoulder | | | Implant Surface Treatment | Sand blasted | | no additional treatment | | ICE® surface | | Grit blasted | | no additional treatment | | Blasted with Hydroxyl Apatit | | | Surface Topography | Roughness | | Roughness | | Roughness | | Roughness | | Roughness | | RBM Surface Technology | | {8}------------------------------------------------ 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 {9}------------------------------------------------ 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. {10}------------------------------------------------ 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. {11}------------------------------------------------ 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 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 2016-10-15 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 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); 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.