(267 days)
IPS e.max® Press Abutment Solutions for Viteo Base Ti is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multi-unit cement retained restorations.
IPS e.max Press Abutment Solutions is recommended for the fabrication of:
- Hybrid abutments for single-tooth restorations
- Hybrid abutment crowns for restorations
IPS e.max Press Abutment Solutions for Viteo Base Ti is a prefabricated prosthetic component for endosseous dental implants to support prosthetic restorations in partially or fully edentulous jaws. The Viteo Base-Ti is the apical component of a two-piece abutment. A separate mesostructure fabricated out of IPS e.max Press ceramic is attached to the Viteo Base-Ti extraorally using Multilink Hybrid Abutment Cement (K130436). This part then serves as an intermediary to facilitate the connection of the 2-part abutment to the prosthetic material (crown). The abutment as a whole is intended to be used as an aid in prosthetic rehabilitation for the purpose of providing a suitable chewing function. A compatible screw is included with the Viteo Base-Ti for attachment of the completed hybrid abutment to the implant body. Alternatively, the mesostructure may be fabricated into the prosthetic restoration and attached to the Viteo Base-Ti via the screw to form a hybrid crown/abutment, thereby incorporating the top half of the two-piece abutment into the body of the crown.
The Viteo Base Ti is made of Ti-6Al-4V ELI Titanium Grade 23 and is provided with a compatible screw made of the same materials. Viteo Base-Ti is available in two platform sizes (SD and MD) for various cleared implant systems as described in this summary. The upper part (pillar) of the Viteo Base Ti can be shortened individually, has a blasted surface to support bonding of the restorative part, and has an internal retentive lock to circumvent rotation. The IPS e.max Press Abutment Solutions for Viteo Base Ti are parts of the implant system which consists of:
- Implant Body – marketed by the Implant Manufacturer
- Viteo Base Ti - Titanium part Included in subject device
- Screw - Titanium screw Included in subject device
- IPS e.max Press either as a part of the abutment or a Hybrid Abutment crown included in the subject device.
- Multilink Hybrid Abutment Cement – to bond together the Viteo Base Ti abutment part and the IPS e.max Press ceramic part included in the subject device.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the IPS e.max® Press Abutment Solutions for Viteo Base Ti:
It's important to note that this document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report. Therefore, some information typically found in a full study report (like detailed statistical methods for performance or specific ground truth for training) might be aggregated or summarized to support the substantial equivalence claim.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Benchmarking / Equivalence) | Reported Device Performance (IPS e.max® Press Abutment Solutions for Viteo Base Ti) |
|---|---|
| Mechanical Fatigue: The device should perform equivalently to the predicate devices in dynamic fatigue testing for endosseous implants according to ISO 14801, considering the FDA Guidance Class II Special Controls for Root form Endosseous Dental Implants and Endosseous Dental Abutments. This implies that the device, when integrated with various implant systems, should successfully "run-out" (withstand specified cyclic loading without failure) at a level comparable to or better than the predicate devices. | Mechanical Fatigue: "Worst case evaluation was done for each implant type listed in Table 1. The dynamic fatigue test for endosseous implants acc. ISO 14801 demonstrated that the tested implants systems containing the corresponding Viteo-Abutment run-out successfully. Fatigue results shown in previously cleared titanium bases for the predicate device did not substantially differ from the test results shown for Viteo Base Ti." This indicates successful run-out, demonstrating performance comparable to the predicate devices. |
| Sterilization Efficacy: The sterilization process for the device (if applicable) must be validated according to relevant ISO and ANSI/AAMI standards. (Though the device is "Not delivered sterile" and "Single use only," a steam sterilization is "recommended in the instructions for use" as a final cleaning step, implying validation of this recommended method if the component itself is affected by it). | Sterilization Efficacy: "Sterilization validation according to ISO 17665-1, ISO/TR 17665-2 and ANSI/AAMI ST79." While the device is not pre-sterilized, the cleaning process is validated, and a recommended steam sterilization method is referenced, suggesting its efficacy has been validated for the product's use case. |
| Dimensional Compatibility: The interface of the Viteo Base Ti with the listed compatible implant bodies must be verified for dimensional accuracy and fit. (No specific acceptance criterion value is given, but implied: it must be compatible). | Dimensional Compatibility: "Compatibility of the Viteo Base Ti interface to the implant bodies listed above was verified by measuring Data & tolerance analysis which demonstrated that the Viteo Base-Ti dimensional specifications are compatible with the appropriate implant system." This confirms the device meets the compatibility requirement. |
| Biocompatibility: The device materials must meet biocompatibility requirements according to ISO 10993-1 and ISO 7405. Materials should also meet corrosion resistance standards (ISO 10271:2011 and EN ISO 22674:2006) for total ion release and electrochemical performance. The chemical composition must conform to ASTM F136-08. Testing for hypersensitivity/sensitization, irritation, acute and subchronic systemic toxicity, genotoxicity, and implantation should yield passing results. | Biocompatibility: "The subject device was evaluated for Biocompatibility according to ISO 10993-1 and ISO 7405. The material was tested for corrosion according to ISO 10271:2011 and EN ISO 22674:2006 and met the requirements for those standards for total ion release and electrochemical test. The chemical composition is according to ASTM F136-08... The material was also evaluated for hypersensitivity/sensitization, irritation, acute and subchronic systemic toxicity - oral/inhalation, genotoxicity and Implantation with passing results." All listed biocompatibility criteria were met. |
| Cleaning Validation: A documented cleaning validation must prove the surface is free from any remaining contaminant after the surface blasting procedure. | Cleaning Validation: "A documented cleaning validation proves that the surface is free from any remaining contaminant after the surface blasting procedure." This criterion was met. |
Study Information:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not explicitly stated with specific numbers of devices or tests beyond "Worst case evaluation was done for each implant type listed in Table 1." For fatigue testing, ISO 14801 typically requires a minimum of 5-10 specimens per test group, but the exact number for each implant system is not provided. For dimensional compatibility, "measuring Data & tolerance analysis" likely involved multiple measurements, but a sample size isn't given.
- Data Provenance: Not specified. These are typically laboratory bench tests, so geographic origin isn't critical. The nature is prospective in the sense that fresh devices are tested for performance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This document describes the performance of a mechanical and material dental implant component, not an AI or diagnostic device that requires expert-established ground truth. The 'ground truth' here is adherence to engineering standards and material specifications, verified by testing.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a mechanical/material device, not a diagnostic or AI-assisted system.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "standalone" performance here relates to the physical and material properties of the device itself under specified test conditions, which were indeed performed.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is adherence to established international and national standards (e.g., ISO 14801 for fatigue, ISO 10993-1 for biocompatibility, ASTM F136-08 for material composition). These standards define acceptable performance metrics and testing methodologies, which serve as the objective benchmarks for validation.
-
The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI, so there is no training set.
-
How the ground truth for the training set was established:
- Not applicable. See point 7.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
Ivoclar Vivadent AG % Donna Hartnett Director OA/Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228
Re: K160798
Trade/Device Name: IPS e.max® Press Abutment Solutions for Viteo Base Ti Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 4, 2016 Received: November 14, 2016
Dear Donna Hartnett:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): : K160798
Device Name: IPS e.max® Press Abutment Solutions for Viteo Base Ti
Indications For Use:
IPS e.max Press Abutment Solutions for Viteo Base Ti is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multi-unit cement retained restorations.
IPS e.max Press Abutment Solutions is recommended for the fabrication of:
- Hybrid abutments for single-tooth restorations -
- Hybrid abutment crowns for restorations -
IPS e.max Press Abutment Solutions for Viteo Base-Ti are compatible with the following Implant Systems
| Implant brand and type | Clearance ID | Platform and Implant Diameter(s) | |
|---|---|---|---|
| Straumann® Dental Implant System, | Bone Level®K150938K130222 | NC: 3.3 mm | RC: 4.1, 4.8 mm |
| Nobel Biocare®, | NobelActive®K071370K041661 | NP: 3.5 mm | RP: 4.3, 5.0 mm |
| Biomet 3i® | Osseotite®Certain®K111216 | BI-OC: 3.4 mm | BI-OC: 4.1, 5.0 mm |
| Astra Tech AB | OsseoSpeed®K101732K091239 | OS: 3.5, 4.0 mm | OS: 4.5, 5.0 mm |
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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IPS e.max Press Abutment Solutions for Viteo Base - Ti
| Contact: | Donna Marie Hartnett |
|---|---|
| Company: | Ivoclar Vivadent, AGBendererstrasse 2, FL-9494Schaan, Liechtenstein+423-235-3535 |
| Date Prepared: | December 14, 2016 |
| Proprietary Name: | IPS e.max® Press Abutment Solutions for Viteo Base Ti |
| Classification Name: | Endosseous Dental Implant Abutment (872.3630)(Classification Code NHA) |
IPS e.max Press Abutment Solutions for Viteo Base Ti is a Device Description: prefabricated prosthetic component for endosseous dental implants to support prosthetic restorations in partially or fully edentulous jaws. The Viteo Base-Ti is the apical component of a two-piece abutment. A separate mesostructure fabricated out of IPS e.max Press ceramic is attached to the Viteo Base-Ti extraorally using Multilink Hybrid Abutment Cement (K130436). This part then serves as an intermediary to facilitate the connection of the 2-part abutment to the prosthetic material (crown). The abutment as a whole is intended to be used as an aid in prosthetic rehabilitation for the purpose of providing a suitable chewing function. A compatible screw is included with the Viteo Base-Ti for attachment of the completed hybrid abutment to the implant body. Alternatively, the mesostructure may be fabricated into the prosthetic restoration and attached to the Viteo Base-Ti via the screw to form a hybrid crown/abutment, thereby incorporating the top half of the two-piece abutment into the body of the crown.
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IPS e.max Press Abutment Solutions for Viteo Base - Ti
The Viteo Base Ti is made of Ti-6Al-4V ELI Titanium Grade 23 and is provided with a compatible screw made of the same materials. Viteo Base-Ti is available in two platform sizes (SD and MD) for various cleared implant systems as described in this summary. The upper part (pillar) of the Viteo Base Ti can be shortened individually, has a blasted surface to support bonding of the restorative part, and has an internal retentive lock to circumvent rotation. The IPS e.max Press Abutment Solutions for Viteo Base Ti are parts of the implant system which consists of:
- । Implant Body – marketed by the Implant Manufacturer
- । Viteo Base Ti - Titanium part Included in subject device
- । Screw - Titanium screw Included in subject device
- IPS e.max Press either as a part of the abutment or a Hybrid । Abutment crown included in the subject device.
- -Multilink Hybrid Abutment Cement – to bond together the Viteo Base Ti abutment part and the IPS e.max Press ceramic part included in the subject device.
Primary Predicate Device: Reference predicate device: IPS e.max Press Abutment Solutions (K120053) IPS e.max Press Abutment Solutions for Nobel Biocare (K124008)
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IPS e.max Press Abutment Solutions for Viteo Base - Ti
Indications for Use
IPS e.max Press Abutment Solutions for Viteo Base Ti is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multi-unit cement retained restorations.
IPS e.max Press Abutment Solutions is recommended for the fabrication of:
- -Hybrid abutments for single-tooth restorations
- Hybrid abutment crowns for restorations -
IPS e.max Press Abutment Solutions for Viteo Base-Ti are compatible with the following Implant Systems
| Implant brand and type | Clearance ID | Platform | Implant Diameter(s) |
|---|---|---|---|
| Straumann® Dental ImplantSystem, | Bone Level®K150938K130222 | NC: | 4.1, 4.8 m3.3 mmRC: |
| Nobel Biocare®, | NobelActive®K071370K041661 | NP: | 4.3, 5.0 m3.5 mmRP: |
| Biomet 3i® | Osseotite®Certain®K111216 | BI-OC: | 4.1, 5.0 m3.4 mmBI-OC: |
| Astra Tech AB | OsseoSpeed®K101732K091239 | OS: | 4.5, 5.0 m3.5, 4.0 mmOS: |
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IPS e.max Press Abutment Solutions for Viteo Base Ti
Comparison to predicate device:
| Comparison Matrix (Table 1) | Subject Device | (C.) Predicate Device(s) (primary and reference) | ||
|---|---|---|---|---|
| Name of | Company | Ivoclar Vivadent AG | Ivoclar Vivadent AG | Ivoclar Vivadent AG |
| Device | IPS e.max Press Abutment Solutions forViteo Base Ti | IPS e.max Press Abutment Solutions forStraumann Cementable abutment | IPS e.max PRESS Abutment Solutions forNobel Biocare | |
| 510(k) number | K160798 | K120053 (Primary) | K124008 (Reference) | |
| Classification & Product Code | 872.3630 - NHA | 872.3630 - NHA | 872.3630 - NHA | |
| (D.) Intended useIndications for use | IPS e.max Press Abutment Solutions forViteo Base Ti is intended for use inpartially or fully edentulous mandiblesand maxillae in support of single or multi-unit cement retained restorations.IPS e.max Press Abutment Solutions isrecommended for the fabrication of:- Hybrid abutments for single-tooth restorations- Hybrid abutment crowns for restorations | IPS e.max® Press Abutment Solutions is intendedfor use in partially or fully endentuous mandibles andmaxillae in support of single or multiple-unit cementretained restorations.IPS e.max Press Abutment Solutions isrecommended for the fabrication of:- Hybrid abutments for single-tooth restorations- Hybrid abutment crowns for restorations | IPS e.max Press Abutment Solutions for NobelBiocare is intended for use in partially or fullyendentuous mandibles and maxillae in support ofsingle or multiple-unit cement retained restorations.IPS e.max Press Abutment Solutions for NobelBiocare is recommended for the fabrication of:- Hybrid abutments for single-tooth restorations- Hybrid abutment crowns for restorations |
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IPS e.max Press Abutment Solutions for Viteo Base Ti
| I) Comparison Matrix (Table 1) | Subject Device | (C.) Predicate Device(s) (primary and reference) | |||
|---|---|---|---|---|---|
| Company Name of Device | Ivoclar Vivadent AGIPS e.max Press Abutment Solutions for Viteo Base Ti | Ivoclar Vivadent AGIPS e.max Press Abutment Solutions for Straumann Cementable abutment | Ivoclar Vivadent AGIPS e.max PRESS Abutment Solutions for Nobel Biocare | ||
| Compatible Abutment /Implant Systems | IPS e.max Press Abutment Solutions are compatible for use with the following implant systems:- Nobel Biocare® NobelActive®- Biomet 3i® Osseotite® Certain®- Straumann® Bone Level®- Astra Tech OsseoSpeed® | The following Ti bases and implant bodies are intended to be used with IPS emax Press Abutment Solutions- Straumann RC Cementable abutment D 5.0-6.5mm, GH 1-0-3.0mm, HTi 4.0-5.5mm- Straumann Bone Level RC Implant Ø4.1 or Ø4.8 | The following Ti bases and implant bodies are intended to be used with IPS e.max Press Abutment Solutions for Nobel Biocare:- Nobel Snappy Abutment 4.0 internal tni-channel NP, RP, WP, 6.0- NobelReplace Tapered Implant NP Ø3.5, RP Ø4.3, WP Ø5.0, Ø6.0- Replace Select Tapered Implant NP Ø3.5, RP Ø4.3, WP Ø5.0, Ø6.0 | ||
| (E.) Technological Characteristics | |||||
| pre-fabricated part(s) | Design attributes | Raw material Abutment | Ti-6Al-4V ELI | Ti-6Al-7Nb | Ti-6Al-4V |
| Angulation (implant vs. abutment axis) | straight i.e. 0° | straight i.e. 0° | straight i.e. 0° | ||
| Collar-diameter | 4.5 – 5.2 mm | 5.0 – 6.5 mm | 4.5 , 5.5, 6.5mm | ||
| Height above collar | Nominal 6.0 mm; may shorten to 4.0mm | 4.0 – 5.5 mm | 7.0 mm | ||
| Engaging / Non-Engaging | Engaging | Engaging | Engaging | ||
| Fixation | Abutment Screw | Abutment Screw | Abutment Screw | ||
| Bonding Surface | Blasted 50µm | n.s. | n.s. | ||
| Raw material Screw | Ti-6Al-4V ELI | Ti-6Al-7Nb | Ti-6Al-4V |
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IPS e.max Press Abutment Solutions for Viteo Base Ti
| I) Comparison Matrix (Table 1) | Subject Device | (C.) Predicate Device(s) (primary and reference) | ||
|---|---|---|---|---|
| Name ofCompany | Ivoclar Vivadent AG | Ivoclar Vivadent AG | Ivoclar Vivadent AG | |
| Device | IPS e.max Press Abutment Solutions forViteo Base Ti | IPS e.max Press Abutment Solutions forStraumann Cementable abutment | IPS e.max PRESS Abutment Solutions forNobel Biocare | |
| Illustration ofpre-fabricated part | Image: Abutment for Viteo Base Ti | Image: Abutment for Straumann Cementable abutment | Image: Abutment for Nobel Biocare | |
| Comparison Matrix (Table 1) | Subject Device | (C.) Predicate Device(s) (primary and reference) | ||
| Name ofCompanyDevice | Ivoclar Vivadent AG | Ivoclar Vivadent AG | Ivoclar Vivadent AG | |
| IPS e.max Press Abutment Solutions forViteo Base Ti | IPS e.max Press Abutment Solutions forStraumann Cementable abutment | IPS e.max PRESS Abutment Solutions forNobel Biocare | ||
| restorative part(abutment crown) | Material(s) for AbutmentCrown | Ceramic Ingots(i.e. IPS e.max® press family) | Ceramic Ingots(i.e. IPS e.max® press family) | Ceramic Ingots(i.e. IPS e.max® press family) |
| Retaining of Crown | By cementation | By cementation | By cementation | |
| Max. angulation(implant- vs. crownaxis) | Angular correction allowed between0°-20° | Angular correction allowed between0°-20° | Angular correction allowed between0°-20° | |
| Final Height | Set by Dental technician | Set by Dental technician | Set by Dental technician | |
| Processconstraints | Applicable technique(s)for Abutment Crown | Press techniques | Press technique | Press technique |
| Intended DesignWorkflows | wax-up | wax-up | wax-up | |
| /workflows | Manufacturing Workflow | traditional | traditional | traditional |
| (F.) Performance Data (pre-fabricated part) | ||||
| MechanicalFatigue | Worst case evaluation was done for each implant typelisted in Table 1. The dynamic fatigue test forendosseous implants acc. ISO 14801 demonstratedthat the tested implants systems containing thecorresponding Viteo-Abutment run-out successfully. | The dynamic fatigue test for endosseous implantsacc. ISO 14801 demonstrated that the testedStraumann implant system run-out successfully. | The dynamic fatigue test for endosseous implantsacc. ISO 14801 demonstrated that the tested Nobelimplant system run-out successfully. | |
| Microbial | Sterile | Not delivered sterile | Not delivered sterile | Not delivered sterile |
| Re-useable | Single use only | Single use only | Single use only |
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IPS e.max Press Abutment Solutions for Viteo Base Ti
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IPS e.max Press Abutment Solutions for Viteo Base Ti
Testing Summary:
The following performance testing was submitted in this 510K application to support substantial equivalence:
- . Worst case dynamic fatigue testing according to ISO 14801: Dynamic Fatigue Testing, considering the FDA Guidance Class II Special Controls for Root form Endosseous Dental Implants and Endosseous Dental Abutments. Fatigue results shown in previously cleared titanium bases for the predicate device did not substantially differ from the test results shown for Viteo Base Ti.
- Sterilization validation according to ISO 17665-1, ISO/TR 17665-2 and ANSI/AAMI ST79 .
- Compatibility of the Viteo Base Ti interface to the implant bodies listed above was . verified by measuring Data & tolerance analysis which demonstrated that the Viteo Base-Ti dimensional specifications are compatible with the appropriate implant system.
Biocompatibility:
The subject device was evaluated for Biocompatibility according to ISO 10993-1 and ISO 7405. The material was tested for corrosion according to ISO 10271:2011 and EN ISO 22674:2006 and met the requirements for those standards for total ion release and electrochemical test. The chemical composition is according to ASTM F136-08. The blasted surface is not exposed to the oral environment as the mesostructured or hybrid crown is luted with self-curing cement to the blasted surface extraorally. Therefore, additional biocompatibility testing of the Viteo Base-Ti with blasted surface was not conducted based on risk assessment. The fabricated articles are subject to a cleaning procedure. A documented cleaning validation proves that the surface is free from any remaining contaminant after the surface blasting procedure. Before inserting the fabricated abutment into the patient's mouth, a steam sterilization is recommended in the instructions for use. This does not alter the surface and provides a final cleaning step. The material was also evaluated for hypersensitivity/sensitization, irritation, acute and subchronic systemic toxicity - oral/inhalation, genotoxicity and Implantation with passing results.
Conclusion: The documentation submitted in this premarket notification demonstrates that the IPS e.max Press Abutment Solutions for Viteo Base Ti are substantially equivalent to the primary predicate IPS e.max Press Abutment Solutions (K120053).
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)