(27 days)
No
The summary describes physical dental implants and abutments made of titanium/titanium alloy. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The testing described is focused on material properties, sterilization, and mechanical fatigue.
Yes.
The device is used for surgical placement in the jaw to provide a root form for prosthetic appliance attachment, restoring a patient's chewing function. This directly addresses a medical condition (edentulism) by replacing missing teeth and restoring function, which falls under the definition of a therapeutic device.
No.
The device is an implant and abutment system designed for surgical placement in the jaw arches to restore chewing function by providing support for prosthetic restorations. It is a therapeutic device rather than a diagnostic one.
No
The device description clearly details physical components made of titanium/titanium alloy, such as dental implants and abutments, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Implantswiss Dental Implant System and Implantswiss Dental Abutment System are physical devices intended for surgical placement in the jaw and for supporting prosthetic restorations to restore chewing function. They are implanted directly into the patient's body.
- Lack of Diagnostic Testing: There is no mention of any testing performed on biological samples or any diagnostic purpose for these devices. Their function is entirely mechanical and structural.
Therefore, these devices fall under the category of medical devices, specifically dental implants and abutments, rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.
Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Implantswiss Dental Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. This submission provides additional models to the existing family of implants and abutments.
The Implantswiss Dental Implants are provided as bone level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The additional devices added in this submission are all bone level implants, manufactured of pure titanium. The subject implant bodies have the same surface modification as the existing/cleared devices.
The Implantswiss Bone Level Implants have diameters of 3.3 mm, 4.3 mm 4.8 mm, and 5.5mm with lengths of 8 mm. 10 mm. 12 mm. Additional implant models are 3.3 mm diameter implants with straight design and 3.7 mm diameter implants with hybrid design (tapered apex).
The Implantswiss Dental Abutment System is used in combination with Implantswiss dental implants to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. The Implantswiss Dental Abutment System consists of provisional (temporary) and final type abutments, abutment screws, and the Healing Cap, a protective cover. The dental abutment provides the link between the dental implant and the prosthetic restoration that restores the chewing function.
The Implantswiss Dental Abutment System consists of Healing, Solid, Couple, Angled, Multi, O-ring, Multi-Unit. Premill, and Locator abutments with diameters Ø 5.5 mm. Ø 6.5 mm. Ø 6.5 mm have lengths of 8.9 mm, 9.9 mm, 11.9 mm, 12.9 mm and 10.4 mm, 11.4 mm, 12.4 mm, 13.4 mm, 14.4 mm. Non-hex Couple abutments with diameters Ø 5.5 mm, Ø 6.5 mm have lengths of 8.7 mm, 9.7 mm, 10.7 mm, 11.7 mm and 12.7 mm.
Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm with lengths varying from 10.57 mm to 12.57 mm. Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 11.06 mm to 13.13 mm. Non-hex Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.37 mm to 12.38 mm. Nonhex Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.86 mm to 12.93 mm. Tissue Level Angled Abutments have 15° angles with diameter Ø 3.5 mm with length 9.8 mm.
Bone Level Solid Abutments have diameters of Ø 5.5 mm and Ø 6.5 mm with lengths between 12.4 mm to 16.4 mm.
Bone Level O-ring Abutments have diameters of Ø 3.42 mm and Ø 3.7 mm with lengths between 10.1 mm to 13.1 mm. Tissue Level O-ring Abutments have a diameter of 3.5 mm with lengths 9.1 mm, 11.1mm and 13.1 mm.
Bone Level Multi Abutments have diameter of Ø 5.5 mm with length 15.63 mm. Non-Hex Bone Level Multi Abutments have a diameter of Ø 5.5 mm with length 15.63 mm.
Bone Level Healing Abutments have diameters of Ø 5.5 mm with lengths 9.5 to 13.5 mm. Tissue Level Healing Abutments have diameter of Ø 6.4 mm with lengths 7.4 mm, 8.4 mm and 9.9 mm.
Bone Level Locator Abutments have diameter of Ø3.86 mm with length 13.95 mm.
Bone Level Multi-Unit Abutments have a diameter Ø 4.8 mm with lengths 8.45 mm and 12.65 mm. Bone Level Multi-Unit Abutments with 17° angle have a diameter Ø 4.8 mm with length 7.2 mm. Bone Level Multi-Unit Abutments with 25° angle have a diameter Ø 4.8 mm with lengths 7.5 mm, 8.5 mm and 9.5 mm.
Bone Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 33.75 mm. Tissue Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 30.08 mm. The finished premill custom abutment diameter is Ø 4.0 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility:
Biocompatibility testing was conducted on the predicate Implantswiss Dental Implant and Implantswiss Dental Abutment Systems per the ISO 10993 series of standards and was leveraged for the subject devices due to identical materials and manufacturing as the predicate.
Sterilization and Shelf Life:
Implantswiss Dental Implants are sterilized using a gamma ray sterilization process ISO 11137-1 and ISO 11737-2 that has been validated to ensure a SAL of 10-6. LAL testing was conducted in accordance with USP . No additional sterilization was required as the validation from the primary predicate may be appropriately leveraged, based on identical materials and manufacturing and worst-case analysis conducted.
The Implantswiss Dental Abutment System is provided non-sterile. The recommended end-user steam gravity sterilization method and sterilization parameters have been validated to achieve an SAL of 10-6 according to ISO 17665-1, ISO 17665-2, and ISO 11737-2. No additional sterilization was required as the validation from the primary predicate may be appropriately leveraged, based on identical materials and manufacturing and worstcase analysis conducted.
Pyrogenicity information from the predicate is applicable to the subject devices, based on worst-case analysis conducted.
Shelf life of the Implantswiss Dental Implant System remains at 2-years. Packaging testing of accelerated aged and real-time aged product previously demonstrated that the sterility of the Implantswiss Dental Implant System is maintained over the 2-year shelf life period. Below tests were performed on the predicate devices and leveraged for the subject, based on worst-case analysis conducted:
-Visual Inspection ASTM F1886
-Dve Penetration ASTM F1929-15
-Seal Peel Strength Test BS EN 868-5:2009
-Sterility test
Mechanical Testing:
Fatigue testing, in accordance with ISO 14801 Dentistry- Implants-Dynamic fatigue test for Endosseous Dental Implants, was performed on the worst-case bone level Implant mated with the worst case Implantswiss Dental Abutment. Results of the fatigue testing presented in the predicate submission found that the worst case (bone level) dental implant/abutment combinations was consistent with FDA Class II Special Controls guidance and ISO 14801. The additional models of the Implants and Implants and Implantswiss Dental Abutments are covered by this testing and do not introduce a new worst-case.
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.
K160221, K161416, K150295, K181037
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image shows the 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2020
Novodent SA % H. Oktay President CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis, Maryland 21401
Re: K200867
Trade/Device Name: Implantswiss Dental Implant System and Implantswiss Dental Abutment System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 31, 2020 Received: April 1, 2020
Dear H. Oktay:
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.
Srinivas Nandkumar, Ph.D. for 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) K200867
Device Name
Implantswiss Dental Implant System and Implantswiss Dental Abutment System
Indications for Use (Describe)
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.
Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summarv
(as required by 21 CFR 807.92)
Implantswiss Dental Implant System Implantswiss Dental Abutment System
510(k) K200867
SUBMITTER
NOVODENT SA Y-PARC Technopole Avenue des Sciences 11 CH-1400 Yverdon-les-Bains Switzerland Office: +41 24 524 28 28 +41 24 524 28 25
Official Correspondent:
H. Semih Oktay, Ph.D. CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis, MD 21401 USA Phone: (410) 674-2060 Email: soktay@cardiomedllc.com Date of Summary: 28 April 2020
DEVICE
| Proprietary name | Implantswiss Dental Implant System
Implantswiss Dental Abutment System |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | Implant, Endosseous, Root-Form |
| Classification name | Endosseous Dental Implant |
| Regulatory Class | II |
| Primary Product Code | DZE |
| Subsequent Product Code | NHA |
| Regulation Number | 21 CFR 872.3640 |
| PREDICATE DEVICE | |
| Primary Predicate Device: | K181266 - Implantswiss Dental Implant System
Implantswiss Dental Abutment System |
| Reference Devices: | K160221 - Implance Dental Implant System
Implance Dental Abutment System
K161416 - Multi-unit Abutment Plus
K150295 - LOCATOR RTx
K181037 - DIO CAD/CAM Abutment |
Device Description
The Implantswiss Dental Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. This submission provides additional models to the existing family of implants and abutments.
The Implantswiss Dental Implants are provided as bone level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The additional devices added in this
4
submission are all bone level implants, manufactured of pure titanium. The subject implant bodies have the same surface modification as the existing/cleared devices.
The Implantswiss Bone Level Implants have diameters of 3.3 mm, 4.3 mm 4.8 mm, and 5.5mm with lengths of 8 mm. 10 mm. 12 mm. Additional implant models are 3.3 mm diameter implants with straight design and 3.7 mm diameter implants with hybrid design (tapered apex).
The Implantswiss Dental Abutment System is used in combination with Implantswiss dental implants to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. The Implantswiss Dental Abutment System consists of provisional (temporary) and final type abutments, abutment screws, and the Healing Cap, a protective cover. The dental abutment provides the link between the dental implant and the prosthetic restoration that restores the chewing function.
The Implantswiss Dental Abutment System consists of Healing, Solid, Couple, Angled, Multi, O-ring, Multi-Unit. Premill, and Locator abutments with diameters 0 5.5 mm. 0 6.5 mm. 0 6.5 mm have lengths of 8.9 mm, 9.9 mm, 11.9 mm, 12.9 mm and 10.4 mm, 11.4 mm, 12.4 mm, 13.4 mm, 14.4 mm. Non-hex Couple abutments with diameters Ø 5.5 mm, Ø 6.5 mm have lengths of 8.7 mm, 9.7 mm, 10.7 mm, 11.7 mm and 12.7 mm.
Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm with lengths varying from 10.57 mm to 12.57 mm. Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 11.06 mm to 13.13 mm. Non-hex Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.37 mm to 12.38 mm. Nonhex Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.86 mm to 12.93 mm. Tissue Level Angled Abutments have 15° angles with diameter Ø 3.5 mm with length 9.8 mm.
Bone Level Solid Abutments have diameters of Ø 5.5 mm and Ø 6.5 mm with lengths between 12.4 mm to 16.4 mm.
Bone Level O-ring Abutments have diameters of Ø 3.42 mm and Ø 3.7 mm with lengths between 10.1 mm to 13.1 mm. Tissue Level O-ring Abutments have a diameter of 3.5 mm with lengths 9.1 mm, 11.1mm and 13.1 mm.
Bone Level Multi Abutments have diameter of Ø 5.5 mm with length 15.63 mm. Non-Hex Bone Level Multi Abutments have a diameter of Ø 5.5 mm with length 15.63 mm.
Bone Level Healing Abutments have diameters of Ø 5.5 mm with lengths 9.5 to 13.5 mm. Tissue Level Healing Abutments have diameter of Ø 6.4 mm with lengths 7.4 mm, 8.4 mm and 9.9 mm.
Bone Level Locator Abutments have diameter of Ø3.86 mm with length 13.95 mm.
Bone Level Multi-Unit Abutments have a diameter Ø 4.8 mm with lengths 8.45 mm and 12.65 mm. Bone Level Multi-Unit Abutments with 17° angle have a diameter Ø 4.8 mm with length 7.2 mm. Bone Level Multi-Unit Abutments with 25° angle have a diameter Ø 4.8 mm with lengths 7.5 mm, 8.5 mm and 9.5 mm.
Bone Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 33.75 mm. Tissue Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 30.08 mm. The finished premill custom abutment diameter is Ø 4.0 mm.
Indication for Use
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to
5
restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading . Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants.
Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.
Substantial Equivalence Comparison
The additional models of the Implantswiss Dental Implant System are equivalent to the primary predicate implants cleared in K181266.
The additional models of the Implantswiss Dental Abutment System are comparable to the predicate and reference devices cleared in K181266, K160221, K150295, K161416, and K181037.
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| | Implantswiss Dental Implant System,
Implantswiss Dental Abutment System | Implantswiss Dental Implant System,
Implantswiss Dental Abutment System |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject | Predicate |
| 510k # | This submission | K181266 |
| Manufacturer | Novodent SA | Novodent SA |
| Indication | Implantswiss Dental Implant System is indicated to use for surgical
placement in the upper and lower jaw arches, to provide a root form
means for single and multiple units' prosthetic appliance attachment
to restore a patient's chewing function. Implantswiss Dental Implant
can be placed with a conventional two stage surgical process with an
option for transmucosal healing or they can be placed in a single
stage surgical process for immediate loading. Immediate loading is
restricted to the anterior mandible based on four splinted-
interforminal placed implants.
Implantswiss Dental Abutment System is used with a dental implant
to provide support to prosthetic restorations such as crown, bridge
and overdentures in partially or fully edentulous patients. Octa and
Multi-Unit Abutment models that contain an abutment post height
less than 4 mm are indicated only for multi-unit loading, such as a
bridge or overdenture. All digitally designed Premill abutments for
use with the Implantswiss Dental Abutment System are intended to
be sent to a Novodent validated milling center for manufacture. | Implantswiss Dental Implant System is indicated to use for surgical
placement in the upper and lower jaw arches, to provide a root form
means for single and multiple units' prosthetic appliance attachment
to restore a patient's chewing function. Implantswiss Dental Implant
can be placed with a conventional two stage surgical process with an
option for transmucosal healing or they can be placed in a single
stage surgical process for immediate loading. Immediate loading is
restricted to the anterior mandible based on four splinted-
interforminal placed implants.
Implantswiss Dental Abutment System is used with a dental implant
to provide support to prosthetic restorations such as crown, bridge
and overdentures in partially or fully edentulous patients. Octa and
Multi-Unit Abutment models that contain an abutment post height
less than 4 mm are indicated only for multi-unit loading, such as a
bridge or overdenture. |
| Design | Threaded root-form bone level implants with hybrid designs and
Morse taper internal hexagon or internal octagonal abutment interface | Threaded root-form bone or tissue level implant with hybrid and
straight designs and Morse taper internal hexagon or internal
octagonal abutment interface. |
| Implant
Sizes
Bone Level | 3.3x8, 3.3x10, 3.3x12, 3.3x14
3.7x8, 3.7x10, 3.7x12, 3.7x14 | 3.3x8, 3.3x10, 3.3x12, 3.3x14
3.7x8, 3.7x10, 3.7x12, 3.7x14
4.3x8, 4.3x10, 4.3x12, 4.3x14
4.8x8, 4.8x10, 4.8x12, 4.8x14
5.5x8, 5.5x10, 5.5x12 |
| Implant
Sizes
Tissue Level | Not applicable | 3.7x8, 3.7x10, 3.7x12, 3.7x14
4.3x8, 4.3x10, 4.3x12, 4.3x14
4.8x8, 4.8x10, 4.8x12, 4.8x14
5.5x8, 5.5x10, 5.5x12 |
| | Implantswiss Dental Implant System,
Implantswiss Dental Abutment System | Implantswiss Dental Implant System,
Implantswiss Dental Abutment System |
| | Subject | Predicate |
| 510k # | This submission | K181266 |
| Materials | Commercially Pure Titanium Grade 4 | Commercially Pure Titanium Grade 4: Ø4.3, 4.8, 5.5 BL, all TL
Titanium Ti6Al4V ELI: Ø3.3, 3.7 BL implants |
| Surface
treatment | | Sandblasted Rough Acid-etched (SRA) surface |
| Sterilization | | Gamma |
| Standards for
Titanium | ASTM F-67 | ASTM F-67 &
ASTM F-136 |
Implantswiss Dental Implant System and Implantswiss Dental Abutment System Substantial Equivalence
7
8
Implantswiss Dental Implant System Substantial Equivalence Comparison
The additional models of the Implantswiss Dental Implants are the same or similar to the primary predicate Implantswiss Dental Implant System (K181266) with respect to indication for use, design, size and dimensions and material composition.
- . The new implant models have the same intended use. The only difference for the subject and primary predicate Indications for Use is in reference to milling a new abutment type and this difference is acceptable as discussed in the applicable abutment section
- The new implant models in the Implantswiss Dental Implant System have the same maximum implant diameter. Bench testing on the worst-case dental implant of the subject devices found acceptable fatigue resistance properties. The primary predicate fating addresses the worstcase assembly of subject devices.
- . The minimum/maximum implant lengths for the additional models of the Implantswiss Dental Implant System are 8 mm - 14 mm, the same as for the predicate.
- The additional models, diameter 3.3 mm 3.7 mm and length 8 -14 mm implant, have the same . surface treatment as the predicate device Implantswiss Dental Implant System and Implantswiss Dental Abutment System (K181266) in the surface treatment.
- . The additional implant models in the Implantswiss Dental Implant System are all bone level implants, whereas the original had both bone level and tissue level designs.
- . The additional models are manufactured from Commercially Pure Titanium Grade 4, whereas the predicate models were available in both pure titanium and titanium alloy.
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Implantswiss Dental Abutment System Substantial Equivalence Comparison
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Trade Name | Implantswiss Dental Implant System, | ||
| Implantswiss Dental Abutment System | Implantswiss Dental Implant System, | ||
| Implantswiss Dental Abutment System | Implance Dental Implant | ||
| Implance Dental Abutment System | |||
| Manufacturer | NOVODENT SA | NOVODENT SA | AGS Medikal İth. İhr. Tic. Ltd. Şti. |
| 510(k) No. | This submission | K181266 | K160221 |
| Material | Bone Level: Titanium Ti6A14V ASTM F-136 | ||
| Tissue Level: Titanium Grade 4 ASTM F-67 | |||
| Screw: Titanium Ti6Al4V ELI ASTM F136 | Bone Level: Titanium Ti6A14V ASTM F-136 | ||
| Tissue Level: Titanium Grade 4 ASTM F-67 | |||
| Screw: Titanium Ti6Al4V ELI ASTM F136 | Bone Level: Titanium Ti6Al4V ELI ASTM | ||
| F-136 | |||
| Tissue Level: Commercially Pure Titanium | |||
| Grade 4 ASTM F-67 | |||
| Screw: Titanium Ti6Al4V ELI ASTM | |||
| F136 | |||
| Surface Treatment | Machine Surface | Machine Surface | Machine Surface |
| Sterile | Steam Sterilization by user | ||
| (Delivered non sterile) | Steam Sterilization by user | ||
| (Delivered non sterile) | Steam Sterilization by user | ||
| (Delivered non sterile) | |||
| Couple Abutment | |||
| Design | Image: Couple Abutment Design | Image: Couple Abutment Design | Image: Couple Abutment Design |
| Couple Abutment | |||
| Diameters | |||
| (mm) | Bone Level Implant: Ø 5.5 mm, Ø 6.5 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm | |
| Tissue Level Implant: Ø 5.2 mm, Ø 6.4 | |||
| mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 | ||
| mm, Ø 5.5 mm, Ø 6.5 mm | |||
| Tissue Level Implant: Ø 5.2 mm, Ø 6.4 | |||
| mm | |||
| Angled Abutment | |||
| Design | Image: Angled Abutment Design | Image: Angled Abutment Design | |
| Angled Abutment | |||
| Diameters | |||
| (mm) | Bone Level Implant (15°, 25°): Ø 5.5 mm, | ||
| Ø 6.5 mm | |||
| Tissue Level Implant (25°): Ø 3.5 mm | Bone Level Implant (15°): Ø 3.7 mm, | ||
| Bone Level Implant (25°): Ø 4.5 mm, | |||
| Tissue Level Implant (15°): Ø 3.5 mm | Bone Level Implant (15°): Ø 3.7 mm, | ||
| Bone Level Implant (15°, 25°): Ø 4.5 mm, | |||
| Ø 5.5 mm, Ø 6.5 mm | |||
| Tissue Level Implant (25°): Ø 3.5 mm | |||
| Subject Device | Predicate Device | Reference Device | |
| Trade Name | Implantswiss Dental Implant System, | ||
| Implantswiss Dental Abutment System | Implantswiss Dental Implant System, | ||
| Implantswiss Dental Abutment System | Implance Dental Implant | ||
| Implance Dental Abutment System | |||
| Manufacturer | NOVODENT SA | NOVODENT SA | AGS Medikal İth. İhr. Tic. Ltd. Şti. |
| Solid Abutment Design | Image: Solid Abutment Design Subject Device | Image: Solid Abutment Design Predicate Device | Image: Solid Abutment Design Reference Device |
| Solid Abutment Diameters (mm) | Bone Level Implant: Ø 5.5 mm, Ø 6.5 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm | |
| Tissue Level Implant: Ø 3.5 mm, Ø 4.3 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm, Ø 5.5 mm, Ø 6.5 mm | ||
| Tissue Level Implant: Ø 3.5 mm, Ø 4.3 mm | |||
| O-ring Abutment Design | Image: O-ring Abutment Design Subject Device | Image: O-ring Abutment Design Predicate Device | Image: O-ring Abutment Design Reference Device |
| O-ring Abutment Diameters (mm) | Bone Level Implant: Ø 3.42 mm, Ø 3.7 mm | ||
| Tissue Level Implant: Ø 3.5 mm | Bone Level Implant: Ø 2.9 mm, Ø 4.5 mm, | Bone Level Implant: Ø 2.9 mm, Ø 3.42 mm, Ø 3.5 mm, Ø 4.5 mm, | |
| Tissue Level Implant: Ø 3.5 mm | |||
| Multi Abutment Design | Image: Multi Abutment Design Subject Device | Image: Multi Abutment Design Predicate Device | Image: Multi Abutment Design Reference Device |
| Multi Abutment Diameters (mm) | Bone Level Implant: Ø 5.5 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5mm | |
| Tissue Level Implant: Ø 5.2 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm, Ø 5.5 mm | ||
| Tissue Level Implant: Ø 5.2 mm | |||
| Subject Device | Predicate Device | Reference Device | |
| Trade Name | Implantswiss Dental Implant System, | ||
| Implantswiss Dental Abutment System | Implantswiss Dental Implant System, | ||
| Implantswiss Dental Abutment System | Implance Dental Implant | ||
| Implance Dental Abutment System | |||
| Manufacturer | NOVODENT SA | NOVODENT SA | AGS Medikal İth. İhr. Tic. Ltd. Şti. |
| Healing Abutment | |||
| Design | Image: Healing Abutment Design Subject Device | Image: Healing Abutment Design Predicate Device | Image: Healing Abutment Design Reference Device |
| Healing Abutment | |||
| Diameters | |||
| (mm) | Bone Level Implant: Ø 5.5 mm, Ø 6.5 mm | ||
| Tissue Level Implant: Ø 6.4 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm | ||
| Tissue Level Implant: Ø 5.2 mm | Bone Level Implant: Ø 3.7 mm, Ø 4.5 mm, Ø 5.5 mm, Ø 6.5 mm | ||
| Tissue Level Implant: Ø 3.7 mm, Ø 6.4 mm | |||
| Brief Comparison | The additional models of the subject device have the same basic design with additional diameters as compared to the predicate device | ||
| (K181266). Additional dimensional features not addressed by the primary predicate are addressed by the reference device, K160221, | |||
| by identical dimensions or a range which encompasses the subject dimensions. |
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| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Trade Name | Implantswiss Dental Implant | ||
| System | |||
| Implantswiss Dental | |||
| Abutment System | Implantswiss Dental Implant | ||
| System | |||
| Implantswiss Dental | |||
| Abutment System | LOCATOR RTx | ||
| Manufacturer | NOVODENT SA | NOVODENT SA | Zest Anchors, LLC |
| 510(k) No. | This submission | K181266 | K150295 |
| Material | Abutments- Titanium Ti6Al4V ELI ASTM F-136 | Abutments- Titanium Ti6Al4V ELI ASTM F-136 | Titanium |
| Sterile | Steam Sterilization by user | ||
| (Delivered non sterile) | Steam Sterilization by user | ||
| (Delivered non sterile) | Steam Sterilization by user | ||
| (Delivered non sterile) | |||
| Locator | |||
| Abutment | |||
| Design | |||
| Diameters | |||
| (mm) | $Ø$ 3.86 mm | $Ø$ 3.86 mm | $Ø$ 3 - 7 mm |
| Cuff Height | |||
| (mm) | 6mm (for 3.3 mm diameter | ||
| implant) | 1-2-3-4-5 mm (for 3.3 | ||
| diameter implant) | |||
| 1-2-3-4-5-6 mm (for 3.7 mm, | |||
| 4.3 mm, 4.8 mm and 5.5 mm | |||
| diameter implant) | 1, 2, 3, 4, 5, and 6 mm (for | ||
| 3.0 mm – 7.0 mm diameter | |||
| implant) | |||
| Brief | |||
| Comparison | The primary predicate and reference device Indications for Use do not include any device- | ||
| specific language for the Locator abutment that would need to be included in the subject | |||
| Indications for Use. The Implantswiss Locator abutment is same design as the predicate | |||
| (K181266) and proposes an additional cuff height option for the 3.3mm diameter implant | |||
| compatible locator abutment. The abutment gingival height and abutment post height are | |||
| within the range of the reference device (K150295). |
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| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Trade Name | Implantswiss Dental Implant System | ||
| Implantswiss Dental Abutment System | Implantswiss Dental Implant | ||
| Implantswiss Dental Abutment System | Multi-unit Abutments Plus | ||
| Manufacturer | NOVODENT SA | NOVODENT SA | Nobel Biocare AB |
| 510(k) No. | This submission | K181266 | K161416 |
| Material | Abutments and screws: Titanium Ti6Al4V ELI ASTM F-136 | Abutments and screws: Titanium Ti6Al4V ELI ASTM F-136 | Abutments and screws - Titanium |
| vanadium alloy | |||
| vanadium alloy | |||
| Sterile | Steam Sterilization by user | ||
| (Delivered non sterile) | Radiation sterilization | ||
| (Delivered non sterile) | |||
| Multi-Unit | |||
| Abutment Design | Image: Multi-Unit Abutment Design | Image: Multi-Unit Abutment Design | |
| Diameters | Ø 4.8 (0°, 17°, 25°) mm | Ø 4.8 (17°) mm | Ø 4.8 (0°, 17°, 30°) mm |
| Brief Comparison | The primary predicate and reference device Indications for Use do not include any device-specific language for the Multi-Unit | ||
| abutment that would need to be included in the subject Indications for Use. The additional models of the Implantswiss Multi-Unit | |||
| Abutment have the same diameter and material as the predicate models, with two new angulations. The angulation of the subject | |||
| device is within the range of angulation of the reference device. Multi-unit Abutment Plus (K161416). |
Implantswiss Multi-Unit Abutment
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Implantswiss Premill Abutment
| Subject Device | Reference Device | |
|---|---|---|
| Trade Name | Implantswiss Dental Implant System | |
| Implantswiss Dental Abutment System | DIO CAD/CAM Abutment | |
| Manufacturer | NOVODENT SA | DIO Corporation |
| 510(k) No. | This submission | K181037 |
| Material | Titanium Ti6Al4V ELI ASTM F-136 | Titanium Ti6Al4V ELI ASTM F-136 |
| Sterile | Steam Sterilization by user | |
| (Delivered non sterile) | Steam Sterilization by user | |
| (Delivered non sterile) | ||
| Premill Abutment | Image: Implantswiss Premill Abutment | Image: DIO CAD/CAM Abutment |
| Diameters | Prior to milling: Ø 10mm, Ø 14 mm, Ø 16 mm | |
| Post milling: min Ø 4.0mm, max Ø 6.5 mm | Ø 3.0mm, Ø 3.3mm, Ø 3.8mm, Ø 4.0mm, Ø 4.5mm, Ø 5.0mm, | |
| Ø 5.5mm, Ø 6.0mm, Ø 6.5mm, Ø 7.0mm | ||
| Maximum Allowable | ||
| Angulation | 25° | 29.8° or 29.3° |
| Connection | Internal Hex | Hex / Non Hex |
| Brief Comparison | The size of the finished Implantswiss Premill abutment is within the range of the Reference Device K181037 DIO CAD/CAM Abutment. The subject device Indications for Use includes component- specific language regarding location of milling, the same as the reference device. Both Implantswiss Premill abutment and Reference device are being used in conjunction with dental implants for the purpose of supporting dental prostheses and are CAD/CAM custom abutments intended for fabrication at a validated milling center. |
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The additional models of the Implantswiss Dental Abutment System are the same or similar with respect to indication for use, material composition and basic design features as the predicate Implantswiss Dental Abutment System (K181266), and reference devices: Implance Dental Abutment System (K160221), DIO CAD/CAM Abutment (K181037), Multi-unit Abutment Plus (K161416) and LOCATOR RTx (K150295). The diameter size ranges have been broadened.
- . The new abutment models in the Implantswiss Dental Implant System have larger abutment diameters compared to the predicate. Bench testing on the worst-case dental implant - abutment found acceptable fatigue resistance properties.
- . The subject device is similar in size and technological features as the reference device (K160221).
- . The Implantswiss Locator abutment is same as the predicate (K181266) with respect to diameter and cuff height. This submission proposes an additional cuff height option for the 3.3mm diameter implant compatible locator abutment. The abutment gingival height and abutment post height are within the range of the reference device, LOCATOR RTx (K150295).
- The Implantswiss Premill abutment is within the range of sizes of the Reference Device K181037 DIO ● CAD/CAM Abutment. Both Implantswiss Premill abutment and Reference device are being used in conjunction with dental implants for the purpose of supporting dental prostheses and are CAD/CAM custom abutments fabricated at a validated milling center.
- . The additional models of the Implantswiss Multi-Unit Abutment have the same diameter and material as the predicate models. The angulation of the subject device is within the range of angulation of the reference device, Multi-unit Abutment Plus (K161416).
- The additional models and predicate models are manufactured from both pure titanium alloy. .
- . All digitally designed abutments for use with Implantswiss Premill abutments for CAD/CAM are intended to be sent to a Novodent validated milling center for manufacture.
Summary of Non-clinical Testing
Non-clinical testing was conducted on the primary predicate device (K181266) and determined to be applicable to the subject device, based on rationale provided below.
Biocompatibility
The additional models of Implantswiss Dental Implantswiss Dental Abutments were compared to the predicate devices. Biocompatibility testing was conducted on the predicate Implantswiss Dental Implant and Implantswiss Dental Abutment Systems per the ISO 10993 series of standards and was leveraged for the subject devices due to identical materials and manufacturing as the predicate.
Sterilization and Shelf Life
Implantswiss Dental Implants are sterilized using a gamma ray sterilization process ISO 11137-1 and ISO 11737-2 that has been validated to ensure a SAL of 106. LAL testing was conducted in accordance with USP . No additional sterilization was required as the validation from the primary predicate may be appropriately leveraged, based on identical materials and manufacturing and worst-case analysis conducted.
The Implantswiss Dental Abutment System is provided non-sterile. The recommended end-user steam gravity sterilization method and sterilization parameters have been validated to achieve an SAL of 10-6 according to ISO 17665-1, ISO 17665-2, and ISO 11737-2. No additional sterilization was required as the validation from the primary predicate may be appropriately leveraged, based on identical materials and manufacturing and worstcase analysis conducted.
Pyrogenicity information from the predicate is applicable to the subject devices, based on worst-case analysis conducted.
Shelf life of the Implantswiss Dental Implant System remains at 2-years. Packaging testing of accelerated aged and real-time aged product previously demonstrated that the sterility of the Implantswiss Dental Implant System is maintained over the 2-year shelf life period. Below tests were performed on the predicate devices and leveraged for the subject, based on worst-case analysis conducted:
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-Visual Inspection ASTM F1886 -Dve Penetration ASTM F1929-15 -Seal Peel Strength Test BS EN 868-5:2009 -Sterility test
Mechanical Testing
Fatigue testing, in accordance with ISO 14801 Dentistry- Implants-Dynamic fatigue test for Endosseous Dental Implants, was performed on the worst-case bone level Implant mated with the worst case Implantswiss Dental Abutment. Results of the fatigue testing presented in the predicate submission found that the worst case (bone level) dental implant/abutment combinations was consistent with FDA Class II Special Controls guidance and ISO 14801. The additional models of the Implants and Implants and Implantswiss Dental Abutments are covered by this testing and do not introduce a new worst-case.
Non-clinical testing has demonstrated substantial equivalence of the Implant System and the Implantswiss Dental Abutment System.
Conclusion
Based on the similar designs, materials and applicable performance data, the modified Implant System and Implantswiss Dental Abutment System is substantially equivalent to the identified predicate devices.