(485 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 software, algorithms, image processing, or any other technology that would typically incorporate AI/ML.
No
This device is a dental implant system intended as an artificial replacement to be placed in the jaw to provide anchor points for prosthetic restoration; it is not described as treating or preventing any disease or condition.
No
The device is a dental implant system intended for artificial replacement of teeth, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of materials like Y-TZP and PEEK, intended for surgical implantation and physical connection to prosthetic restorations. There is no mention of software as a component of the device itself.
Based on the provided text, 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 placed in the jaw to provide anchor points for prosthetic restoration. This is a surgical and restorative function, not a diagnostic one.
- Device Description: The description details the materials, design, and function of the dental implants and associated components. It focuses on their mechanical and biological integration within the body, not on analyzing samples from the body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies described focus on mechanical stability, surface properties, and biocompatibility, which are relevant to an implantable medical device, not an IVD.
In summary, the SDS 1.2 dental implant system is a medical device intended for surgical implantation and prosthetic support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
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 8 mm, Apical diameter 3.8 mm, Coronal diameter 5.0 mm; Length 8 mm, Apical diameter 4.6mm, Coronal diameter 6.0 mm; Length 11 mm, Apical diameter 3.25 mm, Coronal diameter 4.2 mm; Length 11 mm, Apical diameter 3.8 mm, Coronal diameter 5.0 mm; Length 11 mm, Apical diameter 4.6 mm, Coronal diameter 6.0 mm; Length 11 mm, Apical diameter 5.4 mm, Coronal diameter 6.0 mm; Length 14 mm, Apical diameter 3.25 mm, Coronal diameter 4.2 mm; Length 14 mm, Apical diameter 3.8 mm, Coronal diameter 5.0 mm; Length 14 mm, Apical diameter 4.6 mm, Coronal diameter 6.0 mm; Length 14 mm, Apical diameter 5.4 mm, Coronal diameter 6.0 mm. 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. 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.
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.
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
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 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 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 SDS1.2 Dental implants meet 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.
K093595, K062542, K171769, K143353
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 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)
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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