(237 days)
Straumann® Variobase® Abutments: The Straumann® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abutments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacturing by a validated milling center.
Straumann® nice® Zirconia discs: Once finalized into a suitable design: n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch. n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units.
The purpose of this bundled premarket notification is to obtain regulatory clearance for the Straumann subject devices: Straumann® Variobase® Abutments (NHA) A two-piece abutment consisting of a Variobase (bottom half) and ceramic component (top half), Straumann® n!ce® Zirconia discs (EIH). Straumann® Variobase® Abutments are two-piece abutments. The Variobase is the bottom half of the two-piece abutment. The top half of the two-piece abutment is a CAD/CAM designed and manufactured ceramic component milled from Straumann n!ce Zirconia (ZrQ2), also subject to this submission as a material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base, forms a finished dental prosthesis. All digitally designed ceramic components for use with the Straumann Variobase abutments are intended to be sent to Straumann for manufacture at a validated milling center. The following materials are available within the digital workflow for the manufacturing of dental prosthetic restorations: (i) low translucency (LT), (ii) high translucency (HT), and (iii) extra high translucency (XT) n!ce Zirconia. The materials come in various shades (excluding White). Straumann Variobase abutments are available to interface with the following Straumann dental implant platforms: Regular Neck (RN), Wide Neck (WN), Regular CrossFit (RC), Wide Base (WB), Regular Base (RB), Narrow TorcFit (NT), Regular TorcFit (RT), Wide TorcFit (WT) and were previously cleared (K120822, K170356, K190082 and K200586). Straumann® n!ce® Zirconia discs are intended to be milled to produce prosthetic restorations for prepared natural teeth and endosseous dental implant abutments. The material is suitable for use in inlays, onlays, veneers, copings, crowns, and multi-unit restorations. Straumann n!ce Zirconia (ZrO2) discs will be offered in 3 translucencies: low translucency (LT), high translucency (HT) and extra high translucency (XT).
The provided text is a 510(k) summary for Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs. It describes the device, its intended use, and compares its technological characteristics and performance to predicate and reference devices to demonstrate substantial equivalence.
However, the document does not describe a study involving a device that uses AI, nor does it discuss acceptance criteria and performance in the way typically expected for an AI/ML medical device submission (e.g., in terms of metrics like sensitivity, specificity, AUC, etc., or human reader performance with and without AI assistance). The "performance testing" section refers to mechanical and material testing (dynamic fatigue, static strength, biocompatibility, sterilization, flexural strength, chemical solubility, CTE, shrinkage factor) to demonstrate that the dental components meet established physical and biological standards.
Therefore, I cannot answer the questions about AI device performance, sample sizes for test sets, expert ground truth adjudication, MRMC studies, or training set details as this information is not present in the provided document.
Assuming this question is posed in the context of an AI/ML medical device, and the provided document is a misunderstanding, I will state explicitly that the document does not contain the requested information regarding AI device performance.
If the question implies that the dental devices themselves are the "device" in question and that their "acceptance criteria" pertain to their physical and material properties, then I can extract some relevant information as follows, though it won't perfectly match the structure of AI/ML device performance reporting.
Based on the provided text, the "device" refers to Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs, which are physical dental prosthetics and materials, not an AI/ML medical device. Therefore, the acceptance criteria and study descriptions do not involve AI performance metrics or human reader studies.
The acceptance criteria are primarily related to biocompatibility, mechanical strength, and material properties as per established international standards for dental materials and implants. The "study that proves the device meets the acceptance criteria" refers to non-clinical performance testing of these physical properties.
Here's an interpretation based on the document's content, tailored to the questions where applicable, but noting the absence of AI/ML-specific details:
1. Table of Acceptance Criteria and Reported Device Performance
For the Straumann® n!ce® Zirconia discs, key mechanical properties are compared to predicate devices, and these represent the performance thresholds that align with ISO 6872 standards. The document implicitly states that the Straumann® Variobase® Abutments also met relevant standards (ISO 14801).
| Feature / Acceptance Criteria (per ISO 6872) | Device Performance (Straumann® n!ce® Zirconia discs) | Predicate Device (Zerion LT) Performance / Standard |
|---|---|---|
| Zirconia class | LT and HT: Class 5; XT: Class 4 | Zerion LT: Class 5; Zerion UTML: Class 4 |
| Flexural strength (MPa) | LT and HT: ≥800 MPa; XT: ≥500 MPa | Zerion LT: ≥800 MPa; Zerion UTML: ≥500 MPa |
| Minimum wall thickness [mm] | n!ce Zirconia LT/HT: 0.4 mm; n!ce Zirconia XT: 0.5 mm | Zerion LT: 0.4 mm; Zerion UTML: 0.5 mm |
| Coping crown angulation | 30° | 30° |
| Chemical solubility | Confirmed to comply with ISO 6872 requirements (explicit values not stated). | (Implicitly compliant with ISO 6872) |
| CTE (Coefficient of Thermal Expansion) | Confirmed to comply with ISO 6872 requirements (explicit values not stated). | (Implicitly compliant with ISO 6872) |
| Shrinkage factor | Confirmed to comply with ISO 6872 requirements (explicit values not stated). | (Implicitly compliant with ISO 6872) |
| Uniformity, freedom from extraneous materials | Confirmed to comply with ISO 6872 requirements (explicit details not stated). | (Implicitly compliant with ISO 6872) |
| Radioactivity | Confirmed to comply with ISO 6872 requirements (explicit details not stated). | (Implicitly compliant with ISO 6872) |
For Straumann® Variobase® Abutments, the document states that "Dynamic fatigue and static strength tests were conducted according to ISO 14801 and the FDA guidance document... and demonstrated the two-piece Straumann Variobase Abutments with Straumann n!ce Zirconia are equivalent to the primary predicate and reference devices." This implies meeting the strength and fatigue requirements of these standards.
Biocompatibility for both devices was confirmed with chemical characterization and in-vitro cytotoxicity testing according to ISO 10993-5, 10993-12, and 10993-18.
Sterilization process for the Abutments was validated according to ISO 17665-1, ISO 17665-2, and applicable FDA guidance.
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the mechanical and biological "test sets." It refers to "tests" and "evaluations" that meet ISO standards, which inherently include sample size requirements, but these are not enumerated.
Data provenance is implicitly "non-clinical laboratory testing" by the manufacturer, or a validated testing partner. It is not patient data (retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these studies is based on objective, standardized physical, chemical, and biological measurements performed in a laboratory, not expert human interpretation (like in imaging studies).
4. Adjudication method for the test set
Not applicable, as ground truth is established by objective measurements against ISO standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth used for these dental devices is based on established international standards (e.g., ISO 6872, ISO 14801, ISO 10993 series) for material properties, mechanical performance, and biocompatibility. This includes objective measurements of flexural strength, chemical composition, thickness, and results from in-vitro cytotoxicity tests.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for physical product testing in this context, as it's not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Institut Straumann AG % Jennifer Jackson Senior Director, Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K222836
Trade/Device Name: Strauman® Variobase® Abutments and n!ce® Zirconia Discs Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, EIH Dated: February 14, 2023 Received: February 14, 2023
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222836
Device Name
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
Indications for Use (Describe)
Straumann® Variobase® Abutments
The Straumann® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abuments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations.
A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion.
Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacturing by a validated milling center.
| 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known) K222836
Device Name
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
Indications for Use (Describe)
Straumann® nice® Zirconia discs
Once finalized into a suitable design:
n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch.
n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Institut Straumann AGPeter Merian-Weg 124002 Basel, Switzerland |
|---|---|
| Contact Person: | Jennifer M. Jackson, MS, RACSr. Director, Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023 |
| Prepared By &Alternate Contact: | Renate ReissAssociate Director Regulatory Affairs and ComplianceInstitut Straumann AGPhone number: +41 61 965 1260 |
| Date of Submission: | May 15, 2023 |
Name of the Device
| Trade Names: | Straumann® Variobase® Abutments and Straumann® n!ce®Zirconia discs |
|---|---|
| Common Name: | Straumann® Variobase® Abutments and Straumann® n!ce®Zirconia discs |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | §872.3630 |
| Device Classification: | II |
| Product Code(s): | Primary product code NHASecondary product code EIH |
| Classification Panel: | Dental |
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Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
510(k) Summary
Predicate Device(s)
Primary Predicate:
- . K120822 – Straumann Cares Variobase Abutments NNC, Straumann Cares Variobase Abutments RN, Straumann Cares Variobase Abutments WN, ST
Reference Devices:
- . K170356 - Straumann Variobase Abutments
- K190082 Straumann BLX Variobase Abutment .
- K200586 Straumann TLX Implant System .
- K072569 Metoxit Cam-Blanks .
- K170050 Z-CAD smile .
Device Description
The purpose of this bundled premarket notification is to obtain regulatory clearance for the Straumann subject devices:
-
. Straumann® Variobase® Abutments (NHA)
A two-piece abutment consisting of a Variobase (bottom half) and ceramic component (top half), -
Straumann® n!ce® Zirconia discs (EIH) .
Straumann® Variobase® Abutments
Straumann Variobase Abutments are two-piece abutments. The Variobase is the bottom half of the two-piece abutment. The top half of the two-piece abutment is a CAD/CAM designed and manufactured ceramic component milled from Straumann n!ce Zirconia (ZrQ2), also subject to this submission as a material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base, forms a finished dental prosthesis. All digitally designed ceramic components for use with the Straumann Variobase abutments are intended to be sent to Straumann for manufacture at a validated milling center. The following materials are available within the digital workflow for the manufacturing of dental prosthetic restorations: (i) low translucency (LT), (ii) high translucency (HT), and (iii) extra high translucency (XT) n!ce Zirconia. The materials come in various shades (excluding White). . Straumann Variobase abutments are available to interface with the following Straumann dental
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Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
510(k) Summary
implant platforms: Regular Neck (RN), Wide Neck (WN), Regular CrossFit (RC), Wide Base (WB), Regular Base (RB), Narrow TorcFit (NT), Regular TorcFit (RT), Wide TorcFit (WT) and were previously cleared (K120822, K170356, K190082 and K200586).
Straumann® n!ce® Zirconia discs
Straumann n!ce Zirconia (ZrQ2) discs are intended to be milled to produce prosthetic restorations for prepared natural teeth and endosseous dental implant abutments. The material is suitable for use in inlays, onlays, veneers, copings, crowns, and multi-unit restorations. Straumann n!ce Zirconia (ZrO2) discs will be offered in 3 translucencies: low translucency (LT), high translucency (HT) and extra high translucency (XT).
Intended Use
Straumann® Variobase® Abutments
Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.
Straumann® n!ce® Zirconia discs
Straumann® n!ce® Zirconia discs are intended to be milled to produce ceramic restorations to restore natural teeth or to be placed on top of abutments.
Indications for Use
Straumann® Variobase® Abutments
The Straumann® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abutments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations.
A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion.
Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacturing by a validated milling center.
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Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
510(k) Summary
Straumann® n!ce® Zirconia discs
Once finalized into a suitable design:
n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch.
n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units.
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables.
Straumann® Variobase® Abutments
Straumann Variobase Abutments are two-piece abutments. The Variobase is the bottom half of the two-piece abutment and is identical to the predicate devices. The top half of the two-piece abutment, the ceramic component milled from Straumann n!ce Zirconia (ZrQz), differs only in the chemical composition. Minor changes in the chemical composition result in a variation of the shade to achieve the desired esthetic color shade while physical requirements comply to ISO 6872. The indications for use statement slightly differs in wording, where the descriptive term prosthetic components is used interchangeably with two-piece dental abutment or titanium base.
Straumann® n!ce® Zirconia discs
The Straumann n!ce Zirconia discs differ only in the chemical composition of the milling discs. Minor changes in the chemical composition result in a variation of the shade to achieve the desired esthetic color shade while physical requirements comply to ISO 6872. The Indications for Use statement for the subject device is phrased differently but has the same meaning as the reference devices.
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Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
510(k) Summary
| Feature | Proposed Device | Primary Predicate | Reference Device | Reference Device | Reference Device |
|---|---|---|---|---|---|
| K222836 | K120822 | K170356 | K190082 | K200586 | |
| Indications for Use | The Straumann® Variobase®abutments are prostheticcomponents placed ontoStraumann dental implants toprovide support for customizedprosthetic restorations.Straumann® Variobase®abutments are indicated forscrew retained single tooth orcement-retained single toothand bridge restorations. Atemporary restoration can beused prior to the insertion ofthe final components tomaintain, stabilize, and formthe soft tissue during thehealing phase. Temporaryrestorations are indicated to beplaced out of occlusion. Finalabutments and restorationsmay be placed into occlusionwhen the implant is fullyosseointegrated. All digitallydesigned copings and/orcrowns for use with theStraumann® Variobase®Abutment system are intendedto be sent to Straumann formanufacturing by a validatedmilling center. | The Straumann® CARES®Variobase™ Abutment is atwo-piece dental abutmentconsisting of the Straumann®Variobase™ Abutment and theStraumann® CARES®Variobase™ Coping which isintended to be placed ontoStraumann dental implants toprovide support for prostheticreconstruction such as crownsand bridges. Straumann®CARES® Variobase™Abutments are indicated forscrew-retained single tooth orcement-retained single toothand bridge restorations.The Straumann® CARES®Variobase™ Coping polycon®ae in combination with theStraumann® Variobase™Abutment is indicated fortemporary (up to 180 days)dental restoration of aStraumann dental implant. | The Straumann VariobaseAbutment is a titanium baseplaced onto Straumann dentalimplants to provide support forcustomized prostheticrestorations. StraumannVariobase Abutments areindicated for screw-retainedsingle tooth or cement-retainedsingle tooth and bridgerestorations. All digitallydesigned copings and/orcrowns for use with theStraumann Variobaseabutment system are intendedto be sent to Straumann formanufacture at a validatedmilling center. | Straumann® Variobase®prosthetic components directlyor indirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations. Theprosthetic restoration (crowns)can be cemented onto theStraumann® Variobase®prosthetic components. Atemporary restoration can beused prior to the insertion ofthe final components tomaintain, stabilize, and shapethe soft tissue during thehealing phase. They must beplaced out of occlusion. Finalabutments and restorationsmay be placed into occlusionwhen the implant is fullyosseointegrated. All digitallydesigned copings and/orcrowns for use with theStraumann® Variobase®Abutment system are intendedto be sent to Straumann formanufacture at a validatedmilling center | Straumann Variobaseprosthetic components directlyconnected to the endosseousdental implant are intended foruse as an aid in prostheticrehabilitations. The prostheticrestoration (crowns) can becemented onto the StraumannVariobase prostheticcomponents. A temporaryrestoration can be used prior tothe insertion of the finalcomponents to maintain,stabilize and shape the softtissue during the healingphase; they must be placed outof occlusion. Final abutmentsand restorations may beplaced into occlusion when theimplant is fullyosseointegrated. All digitallydesigned copings and/orcrowns for use with theStraumann VariobaseAbutment system are intendedto be sent to Straumann formanufacture at a validatedmilling center |
| Ti-base model | •RN (Regular Neck)•WN (Wide Neck)•RC (Regular CrossFit)•RB/WB (Regular Base/WideBase)•WB (Wide Base)•NT (Narrow TorcFit)•RT (Regular TorcFit)•WT (Wide TorcFit) | •RN•WN•RC | •RN•WN•RC | •RB/WB•WB | •NT•RT•WT |
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Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
| 510(k) Summary | |
|---|---|
| -- | ---------------- |
| Feature | Proposed Device | Primary Predicate | Reference Device | Reference Device | Reference Device | FEATURE | PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
|---|---|---|---|---|---|---|---|---|---|
| K222836 | K120822 | K170356 | K190082 | K200586 | K Number | K222836 | K170050 | K072569 | |
| Coping materialCAD design limits:Minimum wallthickness [mm]Coping crown angulation [°](min. GH included in stockdevices) | n!ce Zirconia LT0.4 mm30°n!ce Zirconia HT0.4 mm30°n!ce Zirconia XT0.5 mm30° | Zerion LT0.4 mm30° | Zerion ML0.8 mm30°Zerion UTML0.5 mm30° | Zerion LT, Zerion ML0.4 mm30°Zerion UTML0.5 mm30° | Zerion LT, Zerion ML0.4 mm30°Zerion UTML0.5 mm30° | Indicationfor use | n!ce® Zirconia LT andn!ce® Zirconia HTrestorations areindicated for inlays,onlays, veneers,crowns, and bridgesup to full-arch.Zirconia XTrestorations areindicated for inlays,onlays, veneers,crowns and bridges upto 3 units. | METOXIT Z-CAD®smile blanks areindicated for thepreparation of fullceramic crowns,inlays, onlays, veneersand 3 unit bridges inthe anterior area. Allwhite Z-CAD® smileblanks are indicated tobe coloured with Z-CAD® Liquid smile-TCThe Z-CAD® Liquidsmile-TC will be usedto dye white pre-sintered zirconiarestorations milledfrom Z-CAD® smileblanks in the dentalfield. | Metoxit blanks are indicated for useas a substructure for porcelainfused ceramic fixed dentalrestorations. Limitations are listedin Table 1All blanks are solely by or on theorder of a dental professional.They are not for use by the generalpublic or over-the-counter. |
| Zirconia class according toISO 6872 | LT and HT5XT:4 | Zerion LT5 | Zerion ML5Zerion UTML4 | Zerion LT, Zerion ML5Zerion UTML4 | Zerion LT, Zerion ML5Zerion UTML4 | Zirconiaclassaccording toISO 6872 | LT and HT:5XT4 | Z-CAD® smile4 | Z-CAD HD and One4All5 |
| Flexural strength (MPa) | LT and HT:≥800XT:≥500 | Zerion LT≥800 | Zerion ML≥800Zerion UTML≥500 | Zerion ML≥800Zerion UTML≥500 | Zerion ML≥800Zerion UTML≥500 | Flexuralstrength[MPa] | LT and HT≥800XT≥500 | METOXIT Z-CAD®smile≥500 | Z-CAD HD and One4All≥800 |
| Workflow/technique | CAD design (CARES Visual)21 CFR 820 centralizedmanufacturing (milling) | CAD design (CARES Visual)21 CFR 820 centralizedmanufacturing (milling) | CAD design (CARES Visual)21 CFR 820 centralizedmanufacturing (milling) | CAD design (CARES Visual)21 CFR 820 centralizedmanufacturing (milling) | CAD design (CARES Visual)21 CFR 820 centralizedmanufacturing (milling) | Chemicalcomposition | LTZrO2 + HfO2 + Y2O3: ≥ 98%Y2O3: ≤5.4%Al2O3: <0.4%HTZrO2 + HfO2 + Y2O3: ≥98.0%Y2O3: ≤ 7.5%Al2O3: ≤ 0.1%XTZrO2 + HfO2 + Y2O3: ≥98.0%Y2O3: ≥7.8%Al2O3:≤0.1%Other oxides: < 2.0% | XTZrO2 + HfO2 + Y2O3: ≥98.0%Y2O3: 3: ≥7.8%Al2O3: ≤0.1%Other oxides: < 2.0% | LTZrO2 + HfO2 + Y2O3: ≥ 98.0%Y2O3: ≤ 6%Al2O3: ≤ 0.5%HTZrO2 + HfO2 + Y2O3: ≥ 98.0%Y2O3: ≤7.5 %Al2O3: ≤ 0.5 % |
| Geometry | Ø98.5 mm discs indifferent heights from12 - 30 mm | Ø98.5 mm discs indifferent heights from10 - 25 mm | Ø98.5 mm discs in different heightsfrom 10 - 25 mm |
Table 1 – Comparison of Strauman® Variobase® Abutments (subject device) versus primary predicate and reference devices
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Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
510(k) Summary
Image /page/10/Figure/4 description: The image shows the title of a table. The title is "Table 2 – Comparison of n!ce Zirconia discs (subject device) versus reference devices". The table will likely compare the n!ce Zirconia discs to other reference devices.
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Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
510(k) Summary
Performance Testing
Straumann® Variobase® Abutments
Dynamic fatique and static strength tests were conducted according to ISO 14801 and the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the two-piece Straumann Variobase Abutments with Straumann n!ce Zirconia are equivalent to the primary predicate and reference devices.
The material of the bottom half of the Variobase Abutments is identical to the primary predicate device, therefore, no new issues regarding biocompatibility were raised. The top half of the twopiece abutment, the ceramic component milled from Straumann n!ce Zirconia (ZrO2), differs only in the chemical composition, therefore, biocompatibility was confirmed with chemical characterization and in-vitro cytotoxicity according to ISO 10993-12, and 10993-18.
The sterilization process for the subject devices as recommended in the labeling was validated according to ISO 17665-1, ISO 17665-2, and applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
Straumann® n!ce® Zirconia discs
The Straumann n!ce Zirconia discs are subject to ISO 6872, Dentistry - Ceramic materials. According to ISO 6872 dental ceramics are classified according to their recommended clinical indication and their mechanical properties. The requirements listed apply as per ISO 6872: Uniformity, freedom from extraneous materials, radioactivity, flexural strength, chemical solubility, CTE (coefficient of thermal expansion) and shrinkage factor.
The Straumann n!ce Zirconia (ZrQ2) discs are similar to the reference devices cleared in K072569 and K170050, therefore, no new issues regarding biocompatibility were raised. The ceramic component milled from Straumann n!ce Zirconia (ZrO2) discs were evaluated for chemical characterization and in-vitro cytotoxicity according to ISO 10993-5, . 10993-12 and 10993-18.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject devices in 510(k) submission K222836, the Straumann Variobase Abutments and Straumann n!ce Zirconia discs,
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Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
510(k) Summary
are as safe, as effective, and performs as well as the legally marketed primary predicate device and reference devices cleared under K120822, K190082, K170356, 200586, K170050, and K072569. The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.
§ 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.)