(391 days)
SICtapered Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICtapered Implants are indicated for when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICtapered implants with Ø 3.7 mm Use without splinting is permissible in the anterior and premolar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme. SICvantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICvantage tapered implants with Ø 3.0 mm Use without splinting is permissible in the anterior replacement of maxillary lateral incisors and mandbular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
The SICtapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The vertical fixation screw is secured with a torque of 20 Ncm. The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation. The SICvantage tapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The SICvantage tapered can be used in all bone qualities (D1 – D4). The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation.
The provided text is a 510(k) Premarket Notification summary for dental implants, specifically the SICtapered and SICvantage tapered models. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than detailing a clinical study with acceptance criteria and performance metrics for an AI-powered diagnostic device.
Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be extracted from this document. The document explicitly states: "Non-clinical testing has been performed showing that the device (SICtapered & SICvantage tapered) performs as intended and are substantially equivalent to the predicate device (K173207)." The "tests" listed are related to biocompatibility, sterilization, shelf life, and mechanical fatigue, which are typical for medical devices like implants, not for an AI diagnostic tool.
However, I can provide a very limited interpretation based on the closest relevant information, acknowledging that it does not fit the typical pattern of an AI diagnostic device study.
Based on the provided document, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a dental implant, not an AI diagnostic device.
The primary "study" performed is a comparison to predicate devices and non-clinical testing (material, sterilization, mechanical). The "acceptance criteria" is that the new device performs "as intended" and is "substantially equivalent" to the predicates, meaning it does not raise new issues of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Interpreted) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Meet ISO 10993 requirements | Passed. Biocompatibility confirmed through Cytotoxicity testing (ISO 10993-5 and -12) on Titanium Grade 4 (ISO 5832-2 / ASTM F67). "The biological safety of therefore considered to be satisfactorily demonstrated." |
| Sterilization Efficacy: Achieve SAL of 10^-6 | Passed. Irradiation sterilization validated to demonstrate SAL of 10^-6. |
| Shelf Life: Maintain performance for expected duration | Passed. 5-year device shelf life and packaging safety validated. |
| Mechanical Strength/Fatigue: Withstand dynamic loading | Passed. Dynamic loading test per EN ISO 14801 performed on worst-case SICtapered and SICvantage tapered devices. "Passed according to defined criteria with no unexpected results or significant deviations." |
| Substantial Equivalence to Predicate Devices: | Achieved. The devices are "substantially equivalent to the predicate device SICmax and SICvantage max respectively in terms of indication for use, materials and technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness." (Detailed comparison tables are provided in the source text, showing "Same" or "Substantially Equivalent" for various parameters like indications for use, body contact, material, design, surface treatment, etc.) |
2. Sample sizes used for the test set and the data provenance:
- Test Set (for non-clinical tests): Not explicitly stated in terms of patient or imaging data. The "sample size" here refers to the number of physical implants or test specimens used for lab testing (e.g., fatigue tests, biocompatibility tests). These numbers are not detailed in the summary document.
- Data Provenance: The data provenance for these non-clinical tests would be the specific accredited labs where the tests were performed. The document implies reliance on previous testing for predicate devices ("leveraged for the new device"), suggesting the data is retrospective in the sense of using prior test results. No information on country of origin of testing is provided, beyond the applicant being Switzerland-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes the testing of a physical medical device (dental implant), not an AI diagnostic algorithm that requires expert-established ground truth from medical images. The "ground truth" for these tests are objective, measurable physical and chemical properties (e.g., material composition, sterility levels, mechanical load limits).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used to establish consensus ground truth from multiple human readers for diagnostic studies. The non-clinical tests described in this document rely on established scientific and engineering methodologies for their "ground truth."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This information pertains to an AI diagnostic device. The current document is for a dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This information pertains to an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical/Physical/Chemical Measurements: The ground truth for the non-clinical tests (biocompatibility, sterilization, mechanical fatigue) would be derived from the objective results of the standardized laboratory tests rather than human interpretation or patient outcomes. For example:
- Biocompatibility: Absence of cytotoxic effects, reaction to specific extracts.
- Sterility: Sterility Assurance Level (SAL) measurement.
- Fatigue: Number of cycles to failure under specified loads.
8. The sample size for the training set:
- Not applicable. This document is not describing an AI model and therefore does not have a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI model or training set, this information is irrelevant to the provided document.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
SIC invent AG Cretia McNett Chief Regulatory Officer Birmannsgasse 3 Basel, CH-4055 SWITZERLAND
Re: K210489
Trade/Device Name: SICtapered & SICvantage tapered Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 7, 2022 Received: February 17, 2022
Dear Cretia McNett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210489
Device Name SICtapered & SICvantage tapered
Indications for Use (Describe)
SICtapered
SICtapered Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICtapered Implants are indicated for when adequate primary stability is achieved and with appropriate occlusal loading.
Only applicable for SICtapered implants with Ø 3.7 mm
Use without splinting is permissible in the anterior and premolar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SICvantage tapered
SIC vantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
Only applicable for SICvantage tapered implants with Ø 3.0 mm
Use without splinting is permissible in the anterior replacement of maxillary lateral incisors and mandbular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
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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SIC invent AG SICtapered & SICvantage tapered 510(k) Premarket Notification
Image /page/3/Picture/2 description: The image shows a red circle with the letters "SIC" in the center. The letters are also red. There is a circled "R" symbol in the upper right corner of the circle. The background is white.
DATE PREPARED: March 17, 2022 APPLICANT: SIC invent AG Birmannsgasse 3 4055 Basel Switzerland Tel: + 49 55150429440 Mobile: +49 15121349184 E-Mail: Cretia.McNett@sic-invent.com CONTACT PERSON: Cretia McNett Chief Regulatory Officer Tel: + 49 55150429440 E-Mail: Cretia.McNett@sic-invent.com
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Image /page/4/Picture/1 description: The image shows a red circle with the letters "SIC" in the center, also in red. There is a small "R" in a circle in the upper right corner of the circle. The logo is simple and clean, with a focus on the acronym "SIC".
1 Device Name
| Trade Name: | SICtapered & SICvantage tapered |
|---|---|
| Common Name: | SICtapered & SICvantage tapered |
| Device Classification Name: | Endosseous dental implant |
Classification / Product Code 2
SICtapered & SICvantage tapered can be classified according to following device name and product code:
| Device | RegulationDescription | RegulationMedicalSpecialty | Review Panel | Product Code | RegulationNumber | DeviceClassification |
|---|---|---|---|---|---|---|
| SICtapered | Endosseousdental implant | Dental | Dental | DZE | 872.3640 | 2 |
| SICvantagetapered | Endosseousdental implant | Dental | Dental | DZE | 872.3640 | 2 |
Predicate Device / Reference Device 3
| Device | Predicate Device | Reference Device | Reference Device2 | 510(k) Number | 510(k) Holder |
|---|---|---|---|---|---|
| SICtapered | SICmax | -- | -- | K173207 | SIC invent AG |
| SICvantage tapered | SICvantage max | -- | -- | K173207 | |
| SICtapered Ø 3.7mm / 7.25 mm | -- | Legacy3 6mm LengthImplants | -- | K131097 | Implant Direct SybronManufacturing Llc |
| SICvantage taperedØ 3.0 mm / 9.25 mm | -- | -- | OsseoSpeedProfile EV Ø 3.0mm / 8.00 mm(previously namedOsseoSpeed Plus) | K120414 | Dentsply ImplantsManufacturing GmbH(previously Astra TechAB) |
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Image /page/5/Picture/1 description: The image shows a red circle with the letters "SIC" in red inside the circle. There is a small "R" in a circle in the upper right corner of the larger circle. The letters "SIC" are in a sans-serif font and are centered within the circle. The red color is consistent throughout the image.
4 Device Description
Dental implant SICtapered 4.1
The SICtapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The vertical fixation screw is secured with a torque of 20 Ncm. The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation.
| Implant Sizes: | |||||
|---|---|---|---|---|---|
| Diameter [mm] | Length [mm] | Length [mm] | Length [mm] | Length [mm] | Length [mm] |
| 3.70 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 4.20 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 4.70 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 5.15 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
The table shows which implant body combinations are available.
Dental implant SICvantage tapered 4.2
The SICvantage tapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The SICvantage tapered can be used in all bone qualities (D1 – D4). The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation.
Implant Sizes:
| Diameter[mm] | Length[mm] | Length[mm] | Length[mm] | Length[mm] | Length[mm] |
|---|---|---|---|---|---|
| 3.00 | 9.25 | 11.25 | 12.75 | 14.25 | N/A |
| 3.70 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 4.20 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 4.70 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 5.15 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
001_510k_Summary_v4
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Image /page/6/Picture/1 description: The image shows the logo for SIC, which features the letters "SIC" in red, sans-serif font, enclosed within a red circle. A small registered trademark symbol (®) is positioned in the upper right quadrant of the circle, slightly above and to the right of the "C" in "SIC". The red color and circular design give the logo a clean and modern appearance.
4.3 Compatibility
The FDA-cleared abutments from K173207 are compatible with the above-mentioned SICtapered and SICvantage tapered implants. The SICvantage tapered implants with smallest diameter of Ø3.0 mm are only available to be compatible with FDA-cleared abutments from K173207 with angulation up to 15° under single-unit loading, while the SICtapered and SICvantage tapered dental implants with larger diameter implants (≥ Ø3.7 mm) are compatible with FDA-cleared abutments from K173207 up to 25° angulation under single-unit loading.
5 Indications for Use
SICtapered
SICtapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICtapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
Only applicable for SICtapered implants with Ø 3.7 mm
Use without splinting is permissible in the anterior and premolar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SICvantage tapered
SICvantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
Only applicable for SICvantage tapered implants with Ø 3.0 mm
Use without splinting is permissible in the anterior region for replacement of maxillary and mandibular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
6 Technological Characteristics
The technological characteristics of SICtapered are the technological characteristics of the predicate device SICmax.
The technological characteristics of SICvantage tapered are the technological characteristics of the predicate device SICvantage max.
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Image /page/7/Picture/1 description: The image shows a red logo with the letters "SIC" in the center. The letters are also red. The logo is a circle, and there is a registered trademark symbol in the upper right corner of the circle. The background is white.
6.1 Device Characteristics Table
SICtapered
| Company | SIC invent AG(New Device) | SIC invent AG(Predicate Device) | Result |
|---|---|---|---|
| Device Name | SICtapered | SICmax | - |
| Regulation Number | 872.3640 | 872.3640 | Same |
| Class | 2 | 2 | Same |
| Code | DZE | DZE | Same |
| 510(k) number | K210489 | K173207 | - |
| Indications for Use | SICtapered Implants are intended for useduring dental implantation andoromaxillofacial surgery in the bone of theupper and/or lower jaw arches. Theyprovide support for prosthetics, such asartificial teeth, bars or bridges whichrestore the patient's chewing function.SICtapered Implants are indicated forimmediate loading when adequate primarystability is achieved and with appropriateocclusal loading.Only applicable for SICtapered implantswith Ø 3.7 mmUse without splinting is permissible in theanterior and premolar region. In the molarregion, they must be used in rigidcombination with other implants. In allcases, they may only be where loads arenot extreme. | SICmax Implants are intended for use duringdental implantation and oromaxillofacialsurgery in the bone of the upper and/orlower jaw arches. They provide support forprosthetics, such as artificial teeth, bars orbridges which restore the patient's chewingfunction. SICmax Implants are indicated forimmediate loading when adequate primarystability is achieved and with appropriateocclusal loading.- Only applicable for SICmax implants withØ 3.7 mmUse without splinting is permissible in theanterior and premolar region. In the molarregion, they must be used in rigidcombination with other implants. In allcases, they may only be where loads are notextreme. | Same |
| Type of Body Contact | Direct | Direct | Same |
| Category of Body Contact | Implant devices | Implant devices | Same |
| Contact of Body Contact | Hard tissues, soft tissues, blood, saliva | Hard tissues, soft tissues, blood, saliva | Same |
| Duration of Body Contact | C - Permanent (>30 d) | C - Permanent (>30 d) | Same |
| Implant Diameter [mm] | 3.70 / 4.20 / 4.70 / 5.15 | 3.70 / 4.20 / 4.70 / 5.15 | Same |
| Implant Length [mm] | 7.25 / 9.25 / 11.25 / 12.75 / 14.25 | 7.50 / 9.50 / 11.50 / 13.00 / 14.50 | Substantially equivalent,except for 7.25 mm length,see comparison to K131097reference device below |
| Implant Connection[Index] | Inner hexagon | Inner hexagon | Same |
| Index positions | 6 | 6 | Same |
| Size of connection [mm] | HEX 2.30 mm | HEX 2.30 mm | Same |
| Connection height [mm] | 2.2 mm | 2.2 mm | Same |
| Inner thread | M1.6x0.25 | M1.6x0.25 | Same |
| Prosthetic sizes [mm] | 3.3 mm and 4.2 mm | 3.3 mm and 4.2 mm | Same |
| Design | Two-piece | Two-piece | Same |
| Surface Treatment | Sandblasted, Etched | Sandblasted, Etched | Same |
| Material | Titanium Grade 4 (3.7065) | Titanium Grade 4 (3.7065) | Same |
| Delivery Status | Sterile (Irradiation) | Sterile (Irradiation) | Same |
| Company | SIC invent AG(New Device) | Implant Direct Sybron Manufacturing Llc(Reference Device 1) | Result |
|---|---|---|---|
| Device Name | SICtapered Ø 3.70 mm / 7.25 mm | Legacy3 6mm Length Implants | - |
| Regulation Number | 872.3640 | 872.3640 | Same |
| Class | 2 | 2 | Same |
| Code | DZE | DZE | Same |
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SIC invent AG SICtapered & SICvantage tapered 510(k) Premarket Notification
Image /page/8/Picture/1 description: The image shows a red circle with the letters "SIC" in the center, also in red. A small "R" in a circle is located in the upper right quadrant of the larger circle, indicating a registered trademark. The design is simple and clean, focusing on the acronym within the circular border.
| Company | SIC invent AG(New Device) | Implant Direct Sybron Manufacturing Llc(Reference Device 1) | Result |
|---|---|---|---|
| 510(k) number | K210489 | K131097 | - |
| Indications for Use | SICtapered Implants are intended for useduring dental implantation andoromaxillofacial surgery in the bone of theupper and/or lower jaw arches. Theyprovide support for prosthetics, such asartificial teeth, bars or bridges whichrestore the patient's chewing function.SICtapered Implants are indicated forimmediate loading when adequate primarystability is achieved and with appropriateocclusal loading.Only applicable for SICtapered implantswith Ø 3.7 mmUse without splinting is permissible in theanterior and premolar region. In the molarregion, they must be used in rigidcombination with other implants. In allcases, they may only be where loads arenot extreme. | Legacy' 6mm Length consists of two-pieceimplants for one-stage or two-stage surgicalprocedures. These implants are intended foruse in partially and fully edentulous upperand lower jaws in support of single ormultiple-unit restorations and terminal orintermediate abutment support for fixedbridgework. Implants can be indicated forimmediate loading when good primarystability has been achieved and withappropriate occlusal loading. | SubstantiallyEquivalent |
| Type of Body Contact | Direct | Direct | Same |
| Category of Body Contact | Implant devices | Implant devices | Same |
| Contact of Body Contact | Hard tissues, soft tissues, blood, saliva | Hard tissues, soft tissues, blood, saliva | Same |
| Duration of Body Contact | C - Permanent (>30 d) | C - Permanent (>30 d) | Same |
| Implant Diameter [mm] | 3.70 / 4.20 / 4.70 / 5.15 | 3.70 / 4.20 / 4.70 / 5.20 / 5.70 / 7.00 | Same |
| Implant Length [mm] | 7.25 | 6.00 | SubstantiallyEquivalent |
| Implant Connection[Index] | Inner hexagon | Inner hexagon | Same |
| Index positions | 6 | 6 | Same |
| Size of connection [mm] | HEX 2.30 mm | Hex | SubstantiallyEquivalent |
| Prosthetic sizes [mm] | 3.3 mm and 4.2 | 3.0, 3.5, 4.5, 5.7 | Substantiallyequivalent |
| Design | Two-piece | Two-piece | Same |
| Surface Treatment | Sandblasted, Etched | SBM Blasted, HA Coated | SubstantiallyEquivalent |
| Material | Titanium Grade 4 (3.7065) | Titanium Grade 4 (3.7065) | Same |
| Delivery Status | Sterile (Irradiation) | Sterile (Irradiation) | Same |
SICvantage tapered
| Company | SIC invent AG(New Device) | SIC invent AG(Predicate Device) | Result |
|---|---|---|---|
| Device Name | SICvantage tapered | SICvantage max | - |
| Regulation Number | 872.3640 | 872.3640 | Same |
| Class | 2 | 2 | Same |
| Code | DZE | DZE | Same |
| 510(k) number | K210489 | K173207 | - |
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SIC invent AG SICtapered & SICvantage tapered 510(k) Premarket Notification
Image /page/9/Picture/1 description: The image shows a red circle with the letters "SIC" in red inside the circle. There is a registered trademark symbol in the upper right quadrant of the circle. The letters "SIC" are in a sans-serif font and are centered within the circle. The red color is consistent throughout the image.
| Company | SIC invent AG(New Device) | SIC invent AG(Predicate Device) | Result |
|---|---|---|---|
| Same | |||
| Indications for Use | SICvantage tapered Implants are intendedfor use during dental implantation and oro-maxillofacial surgery in the bone of theupper and/or lower jaw arches. Theyprovide support for prosthetics, such asartificial teeth, bars or bridges whichrestore the patient's chewing function.SICvantage tapered Implants are indicatedfor immediate loading when adequateprimary stability is achieved and withappropriate occlusal loading.Only applicable for SICvantage taperedimplants with Ø 3.0 mmUse without splinting is permissible in theanterior region for replacement ofmaxillary lateral incisors and mandibularincisors. In the premolar and molar region,they must be used in rigid combinationwith other implants. In all cases, they mayonly be where loads are not extreme. | SICvantage max Implants are intended foruse during dental implantation andoromaxillofacial surgery in the bone of theupper and/or lower jaw arches. Theyprovide support for prosthetics, such asartificial teeth, bars or bridges which restorethe patient's chewing function. SICvantagemax Implants are indicated for immediateloading when adequate primary stability isachieved and with appropriate occlusalloading.Only applicable for SICvantage maximplants with Ø 3.0 mmUse without splinting is permissible in theanterior region for replacement of maxillarylateral incisors and mandibular incisors. Inthe premolar and molar region, they mustbe used in rigid combination with otherimplants. In all cases, they may only bewhere loads are not extreme | Same |
| Type of Body Contact | Direct | Direct | Same |
| Category of Body Contact | Implant devices | Implant devices | Same |
| Contact of Body Contact | Hard tissues, soft tissues, blood, saliva | Hard tissues, soft tissues, blood, saliva | Same |
| Duration of Body Contact | C - Permanent (>30 d) | C - Permanent (>30 d) | Same |
| Implant Diameter [mm] | 3.0 | 3.70 / 4.20 /4.70 / 5.15 | Same |
| Implant Length [mm] | 9.25 / 11.75 /12.75 / 14.25 | 7.25 / 9.25 /11.25 / 12.75 /14.25 | Substantially equivalent,- except for 9.25 mm lengthfor 3.0 mm diameter, seecomparison to K120414reference device below- except for 7.25 mm lengthfor 3.70, 4.20, 4.70, and 5.15mm diameters, seecomparison to K131097reference device above |
| ImplantConnection [Index] | Morse taper with swiss cross | Morse taper with swiss cross | Same |
| Index positions | 4 | 4 | Same |
| Size of connection [mm] | 2.2 / 2.5 / 2.9 mm cone | 2.2 / 2.5 / 2.9 mm cone | Same |
| Connection height [mm] | 4.3 mm | 4.3 mm | Same |
| Inner thread | M1.6x0.25 | M1.6x0.25 | Same |
| Prosthetic sizes [mm] | 2.2 mm, 2.5 mm and 2.9 mm | 2.2 mm, 2.5 mm and 2.9 mm | Same |
| Design | Two-piece | Two-piece | Same |
| Surface Treatment | Sandblasted, Etched | Sandblasted, Etched | Same |
| Material | Titanium Grade 4 (3.7065) | Titanium Grade 4 (3.7065) | Same |
| Company | SIC invent AG(New Device) | Dentsply Implants Manufacturing GmbH(Reference Device 2) | Result |
|---|---|---|---|
| Device Name | SICvantage tapered Ø 3.0 mm / 9.25 mm | OsseoSpeed EV Ø 3.0 mm / 8.00 mm | - |
| Regulation Number | 872.3640 | 872.3640 | Same |
| Class | 2 | 2 | Same |
| Code | DZE | DZE | Same |
| 510(k) number | K210489 | K120414 | - |
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Image /page/10/Picture/1 description: The image shows a red circle with the letters "SIC" in the center, also in red. A small "R" in a circle is located in the upper right quadrant of the larger circle, indicating a registered trademark. The red color and simple design make the logo easily recognizable.
| Company | SIC invent AG(New Device)SICvantage tapered Implants are intendedfor use during dental implantation and oro-maxillofacial surgery in the bone of theupper and/or lower jaw arches. Theyprovide support for prosthetics, such asartificial teeth, bars or bridges whichrestore the patient's chewing function.SICvantage tapered Implants are indicatedfor immediate loading when adequateprimary stability is achieved and withappropriate occlusal loading.Only applicable for SICvantage taperedimplants with Ø 3.0 mmUse without splinting is permissible in theanterior region for replacement ofmaxillary lateral incisors and mandibularincisors. In the premolar and molar region,they must be used in rigid combinationwith other implants. In all cases, they mayonly be where loads are not extreme. | (Reference Device 2)The implants are intended for both one- andtwo-stage surgical procedures in thefollowing situations and with the followingclinical protocols:• Replacing missing teeth in single ormultiple unit applications in the mandible ormaxilla.• Immediate placement in extraction sitesand in situations with a partially orcompletely healed alveolar ridge.• Especially indicated for use in soft boneapplications where implants with otherimplant surface treatments may be lesseffective.• Immediate and early loading for allindications, except in single tooth situationson implant shorter than 8 mm or in softbone (type IV) where implant stability maybe difficult to obtain and immediate loadingmay not be appropriate.The intended use for OsseoSpeed EV 3.0 S islimited to placement of maxillary lateralincisors and mandibular incisors. | Result |
|---|---|---|---|
| Indications for Use | SubstantiallyEquivalent | ||
| Type of Body Contact | Direct | Direct | Same |
| Category of Body Contact | Implant devices | Implant devices | Same |
| Contact of Body Contact | Hard tissues, soft tissues, blood, saliva | Hard tissues, soft tissues, blood, saliva | Same |
| Duration of Body Contact | C - Permanent (>30 d) | C - Permanent (>30 d) | Same |
| Implant Diameter [mm] | 3.0 | 3.0 | Same |
| Implant Length [mm] | 9.25 | 8.00 | SubstantiallyEquivalent |
| Implant Connection[Index] | Morse taper with swiss cross | Unique interface (taper with rotation lock) | SubstantiallyEquivalent |
| Design | Two-piece | Two-piece | Same |
| Surface Treatment | Sandblasted, Etched | Blasted, etched | SubstantiallyEquivalent |
| Material | Titanium Grade 4 (3.7065) | Titanium Grade 4 (3.7065) | Same |
| Delivery Status | Sterile (Irradiation) | Sterile (Irradiation) | Same |
6.2 Summary of Technological Characteristics
The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices are also used in the legally marketed predicate devices.
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Image /page/11/Picture/1 description: The image shows the logo for SIC, which is a red circle with the letters "SIC" in red inside the circle. There is a registered trademark symbol in the upper right quadrant of the circle. The logo is simple and clean, and the red color is eye-catching. The logo is likely used to identify a company or product.
7 Performance Data
Non-clinical testing has been performed showing that the device (SICtapered & SICvantage tapered) performs as intended and are substantially equivalent to the predicate device (K173207)
In summary, the following tests were performed:
| Test Type | Description | Results |
|---|---|---|
| Dosemapping | The sterilization procedure, packaging, material and surface treatment of thenew device and predicate device are exactly the same. Therefore, theDosemapping of predicate device SICmax was leveraged for the new device. | Passed according to defined criteriawith no unexpected results orsignificant deviations. |
| Cytotoxicity | The new device and predicate device are made of the same material and thesurface treatment is exactly the same. Therefore, the Cytotoxicity testsaccording to ISO 10993-5 and 10993-12 of predicate device SICmax wasleveraged for the new device. | Passed according to defined criteriawith no unexpected results orsignificant deviations. |
| Bioburden | The new device and predicate device are made of the same material and thesurface treatment is exactly the same. Therefore, the Bioburden tests ofpredicate device SICmax was leveraged for the new device. | Passed according to defined criteriawith no unexpected results orsignificant deviations. |
| Sterility | The sterilization procedure, packaging, material and surface treatment of thenew device and predicate device are exactly the same. Therefore, theSterility tests of predicate device SICmax was leveraged for the new device. | Passed according to defined criteriawith no unexpected results orsignificant deviations. |
| Shelf Life | The sterilization procedure, packaging, material and surface treatment of thenew device and predicate device are exactly the same. Therefore, the ShelfLife tests of predicate device SICmax was leveraged for the new device. | Passed according to defined criteriawith no unexpected results orsignificant deviations. |
| PackagingValidation | The sterilization procedure and packaging of the new device and predicatedevice are exactly the same. Therefore, the Packaging Validation tests ofpredicate device SICmax was leveraged for the new device. | Passed according to defined criteriawith no unexpected results orsignificant deviations. |
| Fatigue Test -Mechanical Test | Dynamic loading test for endosseous dental implants according to EN ISO14801 was performed on the worst case for SICtapered as well as the worstcase for SICvantage tapered devices. | Passed according to defined criteriawith no unexpected results orsignificant deviations. |
7.1 Biocompatibility
The devices (SICtapered & SICvantage tapered) are made of Titanium Grade 4 according to ISO 5832-2 / ASTM F67. This standard specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Cytotoxicity testing according to ISO 10993-5 and ISO 10993-12 have been successfully performed on SICtapered and SICvantage tapered devices.
Based on the evaluation of the material constituent to the devices, SIC invent AG Dental Implants SICtapered & SICvantage tapered meet the requirements of ISO 10993:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process). The biological safety of therefore considered to be satisfactorily demonstrated.
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Image /page/12/Picture/1 description: The image shows the logo for SIC, which is a red circle with the letters "SIC" in red inside the circle. There is a small "R" in a circle in the upper right corner of the circle, indicating that the logo is a registered trademark. The logo is simple and clean, and the red color is eye-catching.
7.2 Sterilization and Shelf Life
SIC invent AG Dental Implants SICtapered & SICvantage tapered in a sterile state. Irradiation sterilization has been validated. Performed validations according to harmonized standards are able to demonstrate the validity of the process and a sterility assurance level (SAL) of 106.
Both Sterile Barrier System for Dental Implants and Shelf life have been validated. Performed tests in accordance with harmonized standards are able to demonstrate packaging safety of our devices. Manufacturer claims related to 5-year device shelf life as well as the suitability of sterile barrier system are confirmed.
The same tests that were used with rational confirmation remain applicable. For sterilization and shelf life, reference can be made to the products tested in the course of K173207, as they are comparable to the SICtapered & SICvantage tapered implants.
8 Substantial Equivalence Summary / Conclusion
Based on available 510(k) information provided herein, SIC invent AG dental implants SICtapered and SICvantage tapered are considered to be substantially equivalent to the predicate device SICmax and SICvantage max respectively in terms of indication for use, materials and technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness.
§ 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.