(274 days)
Ziacom Dental Implant Systems are intended to be surgically placed in the bone of the mandibular or maxillary jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function and to aid in prosthetic rehabilitation. Ziacom Dental Implant Abutments are intended to be used with Ziacom Dental Implants to aid in prosthetic rehabilitation.
The intended use for Ziacom Dental Implant Zinic® NP 3.30mm diameter is limited to replacement of mandibular incisors.
Zinic® and Zinic MT implants are threaded, self-tapping, root-form dental implants manufactured from CP titanium Grade 4 conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The implants have apical flutes, an internal hexagonal abutment interface and a conical bevel at the abutment interface. They are threaded internally for attachment of mating abutments, cover screws, healing abutments or temporary abutments. The coronal portion of the implant has a microthread design. The Zinic design is a straight implant, while Zinic MT implants are tapered in the apical 40% of the implant length. All implants have a grit blasted and acid etched surface, designated Osseonova Surface.
Implants and abutments with the same platform connection are compatible. Zinic and ZinicMT implants are available with following sizes: (Table of sizes provided in the document).
Zinic and ZinicMT implants are provided sterile to the end-user in a single-unit package, and are for single-patient, single-use only. They are provided in ZPlus packaging or Z2Plus packaging, attached to the ZPlus or Z2Plus Mount, respectively, or in NoMount packaging, without an implant mount. Packaging facilitates the aseptic handling and placement of the implant, with the mounts also capable of serving either as a provisional abutment or a definitive abutment. Z2Plus also can serve as a transfer for a Snap-On impression technique.
Subject device abutments include cover screws, healing abutments, provisional abutments, sculptable (prepable) abutments, conical abutments in straight and angled (15°, 25° and 30°) designs, castable abutments (CoCr base plus burn-out sleeve) in straight and angled (15°, 20°) designs, Basic and Unitary Basic abutments to serve as intermediate abutments between the implant and the prosthesis. XDrive multi-unit abutments in straight and angled (17°, 30°) designs.
All subject device abutments have the universal internal implant connection and are compatible with both implant lines, except that NP abutments are compatible only with Zinic NP implants (there are no ZinicMT NP implants). Abutments are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), polyetheretherketone (PEEK) conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or cobalt-chromium-molybdenum alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539).
Subject device abutments include two overdenture abutments (Kirator,ZM-Equator). Kirator overdenture abutments are straight prosthetic abutments that are used for the retention of preexisting or newly fabricated full dentures (classified as implant-retained mucosupported overdentures). ZM-Equator abutments are straight prosthetic abutments used for the retention of tissue-supported implantretained prostheses. Its is indicated in rehabilitation of narrow ridges and/or reduced vertical dimension Each overdenture abutment is the "male" part of a removable prosthesis retention which contains a metal housing cap that incorporate plastic retention with different degrees of elastic retention. Abutments and housing caps are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The different plastic retentions are manufacture from Kepital, Rilsan bmno and Pebax.
All abutments are provided non-sterile to the end-user in a single-unit package, and are for singlepatient, single-use only.
Clinical screws used to attach abutments and prosthetic components to implants are available with an M1.6 thread and 8 mm length to fit NP abutments and implants and with an M1.8 thread and 7.85 mm length to fit RP and WP abutments and implants. They are available in a machined Ti-6AI-4V design and in a design that is hard anodized to provide anti-loosening characteristics, designated Kiran®. Machined titanium alloy screws are anodized for identification, with the M1.6 thread screw that fits NP abutments and implants colored yellow and the M1.8 thread screws that fit RP and WP abutments and implants colored blue. Kiran screws are dark grey.
A TX30 Torx screw is available for retention of the TX30 Mechanized Abutment. It incorporates a 6-lobed internal feature mating with a 6 lobed spherical tip screwdriver to permit driving the screw with the driver inserted through the angled portion of the restoration. It is provided with the Kiran hard anodizing treatment.
Additional screws are available to attach prosthetic components to Basic abutments and to XDrive abutments. Basic screws have an M1.8 thread and are 4.3 mm long, while XDrive screws have an M1.4 thread and are 3.5 mm long. Each is available as an anodized titanium alloy screw or as a Kiran screw with the hard anodizing treatment.
The provided text describes the Ziacom Dental Implant Systems and its substantial equivalence to predicate devices, but it does not contain information about an AI/ML-enabled medical device study or acceptance criteria for such a device.
The document is a traditional 510(k) premarket notification for a Class II medical device (endosseous dental implant). The performance data presented focuses on mechanical strength testing, material characterization (surface roughness, chemistry), biocompatibility (cytotoxicity), and sterilization validation, which are standard for dental implants.
Therefore, I cannot fulfill your request for the following sections as the necessary information is not present in the provided document:
- A table of acceptance criteria and the reported device performance (for an AI/ML device)
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details
- Standalone (algorithm-only) performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document describes the device's technical specifications and how it is demonstrated to be substantially equivalent to existing predicate devices based on non-clinical performance data (mechanical and biological testing), rather than clinical or AI/ML performance.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
July 18, 2019
Ziacom Medical SL % Alvaro Idiago Quality and S&R Manager Calle Búhos, 2 Pinto, 28320 SPAIN
Re: K182908
Trade/Device Name: Ziacom Dental Implant Systems Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 13, 2019 Received: June 17, 2019
Dear Alvaro Idiago:
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Acting Assistant 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
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Indications for Use
510(k) Number (if known) K182908
Device Name Ziacom Dental Implant Systems
Indications for Use (Describe)
Ziacom Dental Implant Systems are intended to be surgically placed in the mandbular or maxillary jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function and to aid in prosthetic rehabilitation. Ziacom Dental Implant Abutments are intended to be used with Ziacom Dental Implants to aid in prosthetic rehabilitation.
The intended use for Ziacom Dental Implant Zinic® NP 3.30mm diameter is limited to replacement of mandbular incisors.
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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510(k) K182908 Summary ZIACOM MEDICAL SL Ziacom Dental Implant Systems
July 18, 2019
ADMINISTRATIVEINFORMATION
| Manufacturer Name | ZIACOM MEDICAL SL |
|---|---|
| Calle Búhos, 2 | |
| 28320 Pinto | |
| Spain | |
| Telephone: | +34 91723 33 06 |
| Fax: | +34 91723 33 07 |
| Official Contact | Álvaro Idiago, Quality and S&R Manager |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Ziacom Dental Implant Systems |
|---|---|
| Common Name | Dental implantDental implant abutment |
| Classification Name | Implant, endosseous, root formEndosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE, NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
| Primary Predicate: | ||
|---|---|---|
| K120414 | OsseoSpeed™ Plus | Astra Tech AB |
| Reference Devices: | ||
| K092341 | Low Profile Abutment | Biomet 3i, Incorporated |
| K133991 | iSy® Implant | Altatec GmbH |
| K160244 | System | Thommen Medical AG |
| K171795 | VARIOunite | Thommen Medical AG |
| K150669 | Thommen Implant System | Neoss Ltd. |
| K142211 | OT EQUATOR® | Rhein '83 Srl |
| K072878 | LOCATOR Implant Anchor | Zest Anchors, Inc. |
INDICATIONS FOR USE
Ziacom Dental Implant Systems are intended to be surgically placed in the bone of the mandibular or maxillary jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function and to aid in prosthetic rehabilitation. Ziacom Dental Implant Abutments are intended to be used with Ziacom Dental Implants to aid in prosthetic rehabilitation.
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The intended use for Ziacom Dental Implant Zinic® NP 3.30mm diameter is limited to replacement of mandibular incisors.
DEVICE DESCRIPTION
Zinic® and Zinic MT implants are threaded, self-tapping, root-form dental implants manufactured from CP titanium Grade 4 conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The implants have apical flutes, an internal hexagonal abutment interface and a conical bevel at the abutment interface. They are threaded internally for attachment of mating abutments, cover screws, healing abutments or temporary abutments. The coronal portion of the implant has a microthread design. The Zinic design is a straight implant, while Zinic MT implants are tapered in the apical 40% of the implant length. All implants have a grit blasted and acid etched surface, designated Osseonova Surface.
Implants and abutments with the same platform connection are compatible. Zinic and ZinicMT implants are available with following sizes:
| Part Number | DESCRIPTION | ImplantLength | BodyDiameter | PlatformDiameter | InternalConnectionDiameter | ScrewSize |
|---|---|---|---|---|---|---|
| ZSS3310 | Zinic Implant NP Ø3,30X10mm | 10 | 3.3 | NP 3.2 mm | 2.1 | M1.6 |
| ZSS3311 | Zinic Implant NP Ø3,30X11,50mm | 11.5 | ||||
| ZSS3313 | Zinic Implant NP Ø3,30X13mm | 13 | ||||
| ZSS3314 | Zinic Implant NP Ø3,30X14,50mm | 14.5 | ||||
| ZSS3785 | Zinic Implant RP Ø3,70X8,50mm | 8.5 | 3.7 | M1.8 | ||
| ZSS3710 | Zinic Implant RP Ø3,70X10mm | 10 | ||||
| ZSS3711 | Zinic Implant RP Ø3,70X11,50mm | 11.5 | ||||
| ZSS3713 | Zinic Implant RP Ø3,70X13mm | 13 | ||||
| ZSS3714 | Zinic Implant RP Ø3,70X14,50mm | 14.5 | ||||
| ZSS4085 | Zinic Implant RP Ø4,00X8,50mm | 8.5 | 4 | RP 3.5 mm | 2.42 | |
| ZSS4010 | Zinic Implant RP Ø4,00X10mm | 10 | ||||
| ZSS4011 | Zinic Implant RP Ø4,00X11,50mm | 11.5 | ||||
| ZSS4013 | Zinic Implant RP Ø4,00X13mm | 13 | ||||
| ZSS4014 | Zinic Implant RP Ø4,00X14,50mm | 14.5 | M1.8 | |||
| ZSS4385 | Zinic Implant RP Ø4,30X8,50mm | 8.5 | 4.3 | |||
| ZSS4310 | Zinic Implant RP Ø4,30X10mm | 10 | ||||
| ZSS4311 | Zinic Implant RP Ø4,30X11,50mm | 11.5 | ||||
| ZSS4313 | Zinic Implant RP Ø4,30X13mm | 13 | ||||
| ZSS4314 | Zinic Implant RP Ø4,30X14,50mm | 14.5 | ||||
| ZSS4685 | Zinic Implant WP Ø4,60X8,50mm | 8.5 | 4.6 | 2.42 | ||
| ZSS4610 | Zinic Implant WP Ø4,60X10mm | 10 | ||||
| ZSS4611 | Zinic Implant WP Ø4,60X11,50mm | 11.5 | ||||
| ZSS4613 | Zinic Implant WP Ø4,60X13mm | 13 | ||||
| ZSS5085 | Zinic Implant WP Ø5,00X8,50mm | 8.5 | 5 | |||
| ZSS5010 | Zinic Implant WP Ø5,00X10mm | 10 | ||||
| ZSS5011 | Zinic Implant WP Ø5,00X11,50mm | 11.5 | ||||
| ZSS5013 | Zinic Implant WP Ø5,00X13mm | 13 | ||||
| Part Number | DESCRIPTION | ImplantLength | BodyDiameter | PlatformDiameter | InternalConnectionDiameter | ScrewSize |
| ZSS3685M | ZinicMT® Implant RP Ø3,60X8,50mm | 8.5 | RP3.5mm | 2.42 | M1.8 | |
| ZSS3610M | ZinicMT® Implant RP Ø3,60X10mm | 10 | 3.6 | |||
| ZSS3611M | ZinicMT® Implant RP Ø3,60X11,50mm | 11.5 | ||||
| ZSS3613M | ZinicMT® Implant RP Ø3,60X13mm | 13 | ||||
| ZSS4085M | ZinicMT® Implant RP Ø4,00X8,50mm | 8.5 | RP3.5mm | |||
| ZSS4010M | ZinicMT® Implant RP Ø4,00X10mm | 10 | 4 | |||
| ZSS4011M | ZinicMT® Implant RP Ø4,00X11,50mm | 11.5 | ||||
| ZSS4013M | ZinicMT® Implant RP Ø4,00X13mm | 13 | ||||
| ZSS4485M | ZinicMT® Implant RP Ø4,40X8,50mm | 8.5 | ||||
| ZSS4410M | ZinicMT® Implant RP Ø4,40X10mm | 10 | 4.4 | |||
| ZSS4411M | ZinicMT® Implant RP Ø4,40X11,50mm | 11.5 | ||||
| ZSS4413M | ZinicMT® Implant RP Ø4,40X13mm | 13 | ||||
| ZSS4885M | ZinicMT® Implant WP Ø4,80X8,50mm | 8.5 | WP4.5mm | |||
| ZSS4810M | ZinicMT® Implant WP Ø4,80X10mm | 10 | 4.8 | |||
| ZSS4811M | ZinicMT® Implant WP Ø4,80X11,50mm | 11.5 | ||||
| ZSS4813M | ZinicMT® ImplantWP Ø4,80X13mm | 13 |
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Zinic and ZinicMT implants are provided sterile to the end-user in a single-unit package, and are for single-patient, single-use only. They are provided in ZPlus packaging or Z2Plus packaging, attached to the ZPlus or Z2Plus Mount, respectively, or in NoMount packaging, without an implant mount. Packaging facilitates the aseptic handling and placement of the implant, with the mounts also capable of serving either as a provisional abutment or a definitive abutment. Z2Plus also can serve as a transfer for a Snap-On impression technique.
Subject device abutments include cover screws, healing abutments, provisional abutments, sculptable (prepable) abutments, conical abutments in straight and angled (15°, 25° and 30°) designs, castable abutments (CoCr base plus burn-out sleeve) in straight and angled (15°, 20°) designs, Basic and Unitary Basic abutments to serve as intermediate abutments between the implant and the prosthesis. XDrive multi-unit abutments in straight and angled (17°, 30°) designs.
All subject device abutments have the universal internal implant connection and are compatible with both implant lines, except that NP abutments are compatible only with Zinic NP implants (there are no ZinicMT NP implants). Abutments are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), polyetheretherketone (PEEK) conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or cobalt-chromium-molybdenum alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539).
Subject device abutments include two overdenture abutments (Kirator,ZM-Equator). Kirator overdenture abutments are straight prosthetic abutments that are used for the retention of preexisting or newly fabricated full dentures (classified as implant-retained mucosupported overdentures). ZM-Equator abutments are straight prosthetic abutments used for the retention of tissue-supported implantretained prostheses. Its is indicated in rehabilitation of narrow ridges and/or reduced vertical dimension Each overdenture abutment is the "male" part of a removable prosthesis retention which contains a metal
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510(k) Summary
housing cap that incorporate plastic retention with different degrees of elastic retention. Abutments and housing caps are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The different plastic retentions are manufacture from Kepital, Rilsan bmno and Pebax.
All abutments are provided non-sterile to the end-user in a single-unit package, and are for singlepatient, single-use only.
Clinical screws used to attach abutments and prosthetic components to implants are available with an M1.6 thread and 8 mm length to fit NP abutments and implants and with an M1.8 thread and 7.85 mm length to fit RP and WP abutments and implants. They are available in a machined Ti-6AI-4V design and
in a design that is hard anodized to provide anti-loosening characteristics, designated Kiran®. Machined titanium alloy screws are anodized for identification, with the M1.6 thread screw that fits NP abutments and implants colored yellow and the M1.8 thread screws that fit RP and WP abutments and implants colored blue. Kiran screws are dark grey.
A TX30 Torx screw is available for retention of the TX30 Mechanized Abutment. It incorporates a 6-lobed internal feature mating with a 6 lobed spherical tip screwdriver to permit driving the screw with the driver inserted through the angled portion of the restoration. It is provided with the Kiran hard anodizing treatment.
Additional screws are available to attach prosthetic components to Basic abutments and to XDrive abutments. Basic screws have an M1.8 thread and are 4.3 mm long, while XDrive screws have an M1.4 thread and are 3.5 mm long. Each is available as an anodized titanium alloy screw or as a Kiran screw with the hard anodizing treatment.
PERFORMANCE DATA
Mechanical testing was performed to ensure that the strength of the Ziacom Implant System is appropriate for its intended use. After determination of the worst-case construct, static and dynamic testing were performed according to ISO 14801 Dentistry - Implants - Dynamic loading test for endosseous dental implants.
To characterize the grit blasted and double acid etched surface that is applied to the endosseous portion of Zinic and ZinicMT implants, implants were treated by the same process as is used for the subject devices, subjected to the same packaging and sterilization process that are used for the subject devices and were analyzed and compared with the same analysis on samples that had not undergone packaging and sterilization. Surface characterization included scanning electron microscopy (SEM) in both conventional and backscattered electron mode to evaluate surface topography and X-ray Photoelectron Spectroscopy (XPS) to evaluate surface chemistry. In addition, cytotoxicity testing was performed. The study concluded that:
- the surface treatment process performed on subject device implants promotes a modification of the pristine machined surface topography
- . the obtained roughness is in agreement with accepted and used values for dental implant surfaces
- . the adopted process and the following cleaning steps vield a clean surface, in chemical terms
- . the complete production cycle, including shipment to Ziacom, relevant packaging and sterilization, does not spoil or modify the surface properties obtained by the treatment
- . dental implants treated according to this process are non-cytotoxic
- . acceptance criteria for surface chemistry and surface roughness have been defined.
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DISCUSSION OF NON CLINICAL TESTS
Cytotoxicity Evaluation
Cytotoxicity testing was performed on the finished Ziacom Dental Implant System components according to ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cvtotoxicity, and ISO 10993-12 Biological evaluation of medical devices – Part 12.Sample preparation and reference materials. Based on the results of these tests the subject device components are considered safe and suitable for their intended use.
Sterilization Validation
The sterile Subject Device (implants) are sterilized by beta irradiation at a nominal dose of 25 kGy (2.5 Mrad). Sterilization has been validated to a sterility assurance level (SAL) of 10° by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 Sterilization of health care products – Radiation – Part 1: Reguirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose.
Abutments and other components are provided non-sterilized by the end-user. The recommended sterilization cycle is moist heat, gravity autoclave at 132°C/270°F for a minimum of 15 minutes using a wrap or pouch, with 15-30 minutes dry time. This cvcle has been validated by the overkill method to a sterility assurance level (SAL) of 106 according to ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO TS 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
Sterile Barrier Validation
Accelerated aging to validate sterile barrier of subject device was conducted after packaging, sterilization and transportation simulation in accordance with ISO 11607-1 (2006), Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [Including: Amendment 1 (2014)], ISO 11607-2 (2006). Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming, Sealing and Assembly Processes [Including: Amendment 1 (2014)] and ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. After accelerated aging, the package samples were evaluated by dye penetration according to ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Bacterial Endotoxin Testing
For the subject device components provided sterile to the end-user bacterial endotoxin testing was performed to ensure that the subject device meets the pyrogen limit specifications. The Limulus amebocyte lysate (LAL) test for detection and quantitation of bacterial endotoxin was conducted in accordance with the United States Pharmacopeia <85>. The level of bacterial endotoxins was determined to be less than 20 EU/Device
EQUIVALENCE TO MARKETED DEVICE
ZIACOM MEDICAL SL submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
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| Primary Predicate:K120414 | OsseoSpeed™ Plus | Astra Tech AB |
|---|---|---|
| Reference Devices: | ||
| K092341 | Low Profile Abutment | Biomet 3i, Incorporated |
| K133991 | iSy® Implant System | Altatec GmbH |
| K160244 | VARIOunite | Thommen Medical AG |
| K171795 | Thommen Implant System | Thommen Medical AG |
| K150669 | Neoss TiBase and CoCr Abutments | Neoss Ltd. |
| K142211 | OT EQUATOR® | Rhein '83 Srl |
| K072878 | LOCATOR Implant Anchor | Zest Anchors, Inc. |
The primary predicate device K120414 is included for substantial equivalence of the subject device implant and abutment designs. The subject device implants have similar design to that of implants in K 120414, including the external thread, cutting flutes, microthread collar, use of an internal antirotational feature and internal thread to mate with abutment screws. Subject device implant body diameters and lengths are within the range of those cleared in K120414 and the material from which the implants are manufactured, unalloyed titanium, is the same. In addition, the primary predicate includes abutments designs and screws similar to those of the subject device and made from the same Ti-6Al-4V alloy
Reference device K092341 includes a short abutment post for single-unit and multi-unit restorations and includes angled low-profile abutments. Reference device K133991 includes an implant mount that also can be used for a restoration, as well as including a grit blasted acid etched (GBE) implant surface. Reference devices K160244 and K171795 include a straight titanium abutment (VARIOunite) that can be used for fabrication of a temporary restoration (VARIOtemp) or a permanent restoration (VARIOflex).
Reference device K150669 includes CoCr alloy abutments made from the same material as subject device CoCr abutments.
Reference device K142211 has similar design to that of subject device abutment body diameters and lengths are within the range of those cleared in K142211 and the material from which the abutments are manufactured is the same. Reference device K142211 includes the same designed accessories that the subject device and the retention caps are made in the same material and dimensions.
Reference device K072878 has similar design to that of subject device abutment body diameters and lengths are within the range of those cleared in K072878 and the material from which the abutments are manufactured is the same. Reference device K072878 includes the accessories with similar design those the subject device (Metal housing and retention caps).
The subject device and the predicate devices all incorporate the same materials and encompass similar ranges of dimensions. Predicate and reference device support substantial equivalence so the implants, abutments, materials, accessories and technologies in manufacture are similar and, in most of case, identical. All subject device components are for single-patient, single-use, and implants are provided sterile. Subject device abutments are provided non-sterile and are to be moist heat sterilized by the end user. Similarly, the primary predicate device K120414 includes abutments that are provide non- sterile and are to be most heat sterilized by the end user.
The Indications for Use Statement for the subject device is similar to that of the primary predicate K120414 for implants and for abutments. Differences in wording do not change the intended use of the devices, which is to provide support for prosthetic restorations.
Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are similar to those of the primary predicate and reference devices and that the effects
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on biocompatibility of any differences that might exist in processing and storage conditions have been evaluated according to ISO 10993-1, including testing according to ISO 10993-5.
In support of substantial equivalence in terms of mechanical performance, dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants was performed. Dynamic testing was performed on worst-case subject device constructs. The results from the testing demonstrated fatigue performance of the subject device to be substantially equivalent to that of the predicate devices and to generally accepted performance requirements.
The basis for the belief of ZIACOM MEDICAL SL that the subject device is substantially equivalent to the predicate devices is summarized in the following Table of Substantial Equivalence.
Overall, the subject device has the following similarities to the predicate devices:
- has the same intended use, .
- . uses the same operating principle,
- incorporates the same basic design,
- incorporates the same or very similar materials and coatings, and
- . has similar packaging and is sterilized using the same materials and processes.
Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.
CONCLUSION
The subject device and the predicate and reference devices have intended use, have similar technological characteristics, and are made of similar materials and coatings. The subject device and the predicate and reference devices encompass the same range of physical dimensions, including diameter and length of the implants, diameter and angulation of the abutments, and the materials and designs of accessories of abutments. The subject device and the predicate and reference devices are packaged in similar materials and sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.
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Table 12.1 Table of Substantial Equivalence – Indications for Use Statement
| Indications for Use Statement | |
|---|---|
| Subject Device | |
| K182908Ziacom Dental Implant SystemZiacom Medical S.L. | Ziacom Dental Implant Systems are intended to be surgically placed in the bone of the mandibular or maxillary jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function and to aid in prosthetic rehabilitation. Ziacom Dental Implant Abutments are intended to be used with Ziacom Dental Implants to aid in prosthetic rehabilitation.The intended use for Ziacom Dental Implant Zinic® NP 3.30mm diameter is limited to replacement of mandibular incisors. |
| Primary Predicate Devices | |
| K120414OsseoSpeedTM PlusAstra Tech AB | Implants:The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeedTM Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.Abutments:Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.Atlantis Abutments:The AtlantisTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous; patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.The AtlantisTM Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous; patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. |
| Reference Devices | Indications for Use Statement |
| K092341Low Profile AbutmentBiomet 3i, Incorporated | BIOMET 3 i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prostheticdevice in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple toothprosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment. |
| K133991iSy® Implant SystemAltatec GmbH | iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular archapproach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load isappropriate. |
| K160244VARIOuniteThommen Medical AG | VARIOflexThommen Medical VARIOflex Abutments are intended to be used in conjunction with Thommen System dental implantsin the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.VARIOtempThommen Medical VARIOtemp Abutments are intended to be used in conjunction with Thommen System dental implantsin the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. |
| K171795Thommen ImplantSystem ThommenMedical AG | Implant:The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. TheELEMENT PF 3.0 is suitable for immediate implantation and restoration in case of replacement of several teeth;prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used forreplacement of the lateral incisors of the upper jaw and the central and lateral incisors of the lower jaw.VARIOunite PF 3.0:Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are forfabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated millingcenter for manufacture.VARIOunite:Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implantsin the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated millingcenter for manufacture. |
| K150669Neoss TiBase and CoCrAbutmentsNeoss Ltd. | Neoss TiBase:Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prostheticrehabilitation The Neoss TiUbase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designedcopings and/or crowns for use with the Neoss TiBase Abutments are to be designed and milled using the Sirona DentalCAD/CAM System.Neoss CoCr Abutments:Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation. |
| Reference Devices | Indications for Use Statement |
| K142211OT EQUATOR®Rhein '83 Srl | The OT Equator® is designed as an endosseous dental implant retentive component used to retain a complete or partialdenture. The OT Equator® is screwed into an endosseous implant in the mandible or maxilla. |
| K072878LOCATOR Implant AnchorZest Anchors, Inc. | The LOCATOR Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures or partialdentures retained in whole or in part by endosseous implants in the mandible or maxilla. denture. The OT Equator® is screwedinto an endosseous implant in the mandible or maxilla. |
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510(k) Summary
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Table 12.2 Tables of Substantial Equivalences – Technological Characteristics
| Comparison | Subject Device | Primary PredicateDevice | Reference Device | Reference Device | Reference Device | Reference Device |
|---|---|---|---|---|---|---|
| K182908 | K120414 | K092341 | K133991 | K160244K171795 | K150669 | |
| Ziacom Dental ImplantSystem | OsseoSpeed™ Plus | Low Profile Abutment | iSy® Implant | VARIOunite,Thommen ImplantSystem | Neoss TiBase andCoCr Abutments | |
| Ziacom Medical S.L. | Astra Tech AB | Biomet 3i,Incorporated | System Altatec | Thommen MedicalAG | Neoss Ltd. | |
| Reason forPredicate | NA | Implant, abutmentdesigns, material | Short abutment postfor single-unitrestoration | Mount used fortemporary restoration,GBE surface | Used for temporary orpermanent restoration(VARIOunite) | CoCr Alloy |
| Design | ||||||
| Implant Diameter(mm) | 3.3, 3.7, 4, 4.3, 4.6, 5.0 | 3.0, 3.6, 4.2, 4.8, 5.4 | NA | 3.8, 4.4, 5.0 | NA | NA |
| Implant Length (mm) | 8, 5, 10, 11.5, 13, 14.5 | 6, 8, 9, 11, 13, 15, 17 | NA | 9, 11, 13 | NA | NA |
| Implant/AbutmentPlatformDiameter (mm) | NP (3.2), RP (3.5),WP (4.5) | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.4, 4.1, 5.0 | 3.8, 4.4, 5.0 | 3.0, 3.5, 4.0, 4.5,5.0, 6.0 | 4.1 |
| Abutment Angle | 0°, 15°, 17°, 20°, 25°,30° | Up to 30° | 0°, 17°, 30° | Up to 20° | Up to 20° | Up to 20° |
| Interface Connection | Internal | Internal | Internal/External | Internal | Internal | Internal |
| Restoration | Single-unit/ Multi-Unit | Single-unit/Multi-Unit | Single-unit/Multi-Unit | Single-unit/Multi-Unit | Single-unit/Multi-Unit | Single-unit/Multi-Unit |
| Material | ||||||
| Implant | Unalloyed Titanium | Unalloyed Titanium | NA | Unalloyed Titanium | NA | NA |
| Implant Surface | Grit blasted, acidetched (GBE) | OsseoSpeed | NA | GBE | NA | NA |
| Abutment | Titanium alloy, PEEK,CoCr alloy | Titanium alloy,PEEK | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy,CoCr alloy |
| Screw | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy |
§ 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.