(166 days)
The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained.
Straumann® CARES® TAN Abutments are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths. The abutments are available with interface geometry compatible with the bone level NC (3.3 mm) and RC (4.1 mm) and the tissue level RN (3.3 mm, 4.1 mm) and WN (4.8 mm) implants. The proposed CARES® TAN abutments are provided in a set that contains the individualized abutment and a corresponding basal screw. The Straumann CARES TAN Abutments allow for individual customization regarding function and esthetics. Straumann CARES TAN Abutments are designed by the customer either by means of a traditional wax-up abutment that is subsequently scanned or by scanning of the intraoral situation and designing of the shape by using software such as Straumann CARES Visual. The design data is then transferred to Straumann where the fabrication of the customized abutment is carried out.
The document describes a 510(k) premarket notification for Straumann® CARES® Titanium Alloy (TAN) Abutments. This submission focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than proving the device meets acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design for proving acceptance criteria is not directly applicable.
Here's an analysis of the provided information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the typical sense of a clinical trial. Instead, it details design limits for the abutments and then provides a list of bench studies conducted to demonstrate the device's performance characteristics. The "Equivalence Discussion" column in the "Technological Characteristics" table also serves as a comparison to predicate devices, inferring acceptance based on similarity or acceptable differences.
| Acceptance Criteria (Inferred from Predicate/Design Limits) | Reported Device Performance (Demonstrated via Bench Studies) |
|---|---|
| Design Limits | |
| Max. Angulation: 0-30° (depending on platform) | CADCAM design process verifies designs within these limits; model verification performed by CAM software. |
| Emergence Offset: 0.1 mm | CADCAM design process verifies designs within these limits; model verification performed by CAM software. |
| Emergence Angle: 65° | CADCAM design process verifies designs within these limits; model verification performed by CAM software. |
| Min. Thickness: 0.4 mm (TAN) | CADCAM design process verifies designs within these limits. (Note: Predicate Ceramic 0.5 mm, Predicate Titanium 0.33 mm. TAN is within this range as a function of material properties.) |
| Smooth Distance: 0.5 mm | CADCAM design process verifies designs within these limits; model verification performed by CAM software. |
| Mechanical Performance | |
| Dynamic fatigue resistance (consistent with FDA guidance and ISO 14801) | Dynamic fatigue test data provided (specific values not detailed in this summary). |
| Veneer bonding strength (consistent with ISO 9693-1) | Veneer testing data provided (specific values not detailed in this summary). |
| Material Performance | |
| Corrosion resistance (consistent with ISO 10271) | Corrosion resistance testing performed (specific values not detailed in this summary). |
| Biocompatibility (consistent with ISO 10993-5 and ISO 10993-18) | Biocompatibility testing (cytotoxicity and chemical analysis) submitted (specific results not detailed in this summary). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to bench studies. For such studies, the "sample size" typically refers to the number of test specimens. However, the specific sample sizes for the dynamic fatigue, veneer, and corrosion resistance tests are not provided in this summary. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being "bench studies."
3. 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)
This information is not applicable as the submission is based on bench studies and a comparison to predicate devices, not on a clinical study requiring expert ground truth for a test set of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable as the device is a dental abutment, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical medical device (dental abutment), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench studies, the "ground truth" would be established by the standardized test methods themselves (e.g., ISO 14801 for dynamic fatigue, ISO 9693-1 for veneer testing, ISO 10271 for corrosion resistance, ISO 10993 for biocompatibility). These international standards define the accepted methods and performance metrics for evaluating such devices. There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for the performance evaluations.
8. The sample size for the training set
This information is not applicable as there is no training set in the context of this device's evaluation (it's not an AI/machine learning device).
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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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 symbol that resembles a caduceus, but instead of snakes, it features three abstract human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
Straumann USA, LLC Mr. Christopher Klaczyk Director, Regulatory and Clinical Affairs 60 Minuteman Road Andover, Massachusetts 01810
Re: K150899
Trade/Device Name: Straumann® CARES® Titanium Alloy (TAN) Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 12, 2015 Received: August 13, 2015
Dear Mr. Klaczyk:
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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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,
Tina Kiang
for Erin I. Keith, M.S. 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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Indications for Use
510(k) Number (if known) K150899
Device Name
Straumann® CARES® Titanium Alloy (TAN) Abutments
Indications for Use (Describe)
The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained.
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)
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5.
510(k) Summary
K150899
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052 |
|---|---|
| Contact Person: | Christopher KlaczykDirector of Regulatory Affairs and Clinical Research |
| Date Prepared: | August 29, 2015 |
| Product Code(s): | NHA (21 CFR 872.3630) |
| Device Class: | II(21 CFR 872.3630) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Proprietary Name: | Straumann® CARES® Titanium Alloy (TAN) Abutments |
| Primary PredicateDevice: | K061277 - Straumann RN CARES Ceramic Coping |
| Reference PredicateDevice(s): | K072151 – P.004 RC CARES Titanium and Ceramic AbutmentK081005 – P.004 NC CARES Titanium and Ceramic Abutment |
| Reference Device(s): | K052272 – Straumann RN CARES Titanium AbutmentK082764 – Straumann CARES WN Titanium Coping |
| Device Description: | Straumann® CARES® TAN Abutments are used for therestoration of Straumann dental implants of different types,endosteal diameters, lengths. The abutments are available withinterface geometry compatible with the bone level NC (3.3 mm)and RC (4.1 mm) and the tissue level RN (3.3 mm, 4.1 mm) andWN (4.8 mm) implants. The proposed CARES® TANabutments are provided in a set that contains the individualizedabutment and a corresponding basal screw.The Straumann CARES TAN Abutments allow for individualcustomization regarding function and esthetics. StraumannCARES TAN Abutments are designed by the customer eitherby means of a traditional wax-up abutment that is subsequently |
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scanned or by scanning of the intraoral situation and designing of the shape by using software such as Straumann CARES Visual. The design data is then transferred to Straumann where the fabrication of the customized abutment is carried out. Design limits are as follows:
| PredicateCeramic | SubjectTANRC, RN 4.1, WN | SubjectTANNC, RN 3.3 | |
|---|---|---|---|
| Parameter | Limit | Limit | Limit |
| Max.Angulation | 30° | 30° | 0° |
| EmergenceOffset | 0.1 mm | 0.1 mm | 0.1 mm |
| EmergenceAngle | 65° | 65° | 65° |
| Min.Thickness | 0.5 mm | 0.4 mm | 0.4 mm |
| SmoothDistance | 0.5 mm | 0.5 mm | 0.5 mm |
The Straumann CARES TAN Abutments can be directly veneered or a dental restoration like a crown or bridge can be cemented to the abutments.
- The Straumann CARES® TAN abutments are indicated for Indications For Use: single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained.
- Intended Use: Prosthetic components connected to the implant are intended for use as an aid in prosthetic rehabilitation.
- Materials: The subject devices are produced from titanium-6aluminum-7niobium alloy (TAN) conforming to ISO 5832-11.
Technological See table below. Characteristics:
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| FEATURE | SUBJECTStraumann® CARES® TANAbutments | PREDICATEStraumann® CARES®Ceramic Abutments(K061277, K072151, K081005) | REFERENCEStraumann® CARES®Titanium Abutments(K052272, K072151, K081005,K082764) | EquivalenceDiscussion |
|---|---|---|---|---|
| Indications for | The Straumann CARES® TAN | Abutments are placed into the | Abutments are placed into the | Equivalent |
| Use | abutments are indicated forsingle tooth replacement andmultiple tooth restorations. Theprosthetic restoration can becemented or directly veneered/screw-retained. | dental implants to providesupport for prosthetic restorationsuch as crowns, bridges andoverdentures.The P.004 NC CARES CeramicAbutment is indicated for singletooth replacements and multipletooth restorations. Theprosthetic restoration can becemented or directlyveneered/screw retained. | dental implants to providesupport for prosthetic restorationsuch as crowns, bridges andoverdentures.The P.004 NC CARES TitaniumAbutment is indicated forcemented restoration. Theabutment can be used in singletooth replacements and multipletooth restorations. | The indicated uses of the subjectand ceramic predicate devicesare equivalent, including theability to be directly veneered;the opening paragraph for theceramic abutments does notmaterially change theindications.The predicate titaniumabutments are not indicated fordirect veneering. |
| Abutment | Titanium-Aluminum-Niobium | Zirconium dioxide ceramic | Commercially pure grade 4 | Equivalent |
| Material | alloy (Ti-6Al-7Nb, TAN) | (ZrO2) | titanium | Different materials, bothmeeting accepted standards foruse in dental restorations |
| FEATURE | SUBJECTStraumann® CARES® TANAbutments | PREDICATEStraumann® CARES®Ceramic Abutments(K061277, K072151, K081005) | REFERENCEStraumann® CARES®Titanium Abutments(K052272, K072151, K081005,K082764) | EquivalenceDiscussion |
| AbutmentApicalDesign | Engaging | Engaging | Engaging | Equivalent |
| BoneLevel | BoneLevel | BoneLevel | The subject TAN abutmentsemploy the same implant-to-abutment platforms as thetitanium predicates. Theceramic predicates do notinclude the WN platform. | |
| Narrow CrossFit (NC) | Narrow CrossFit (NC) | Narrow CrossFit (NC) | ||
| Regular CrossFit (RC) | Regular CrossFit (RC) | Regular CrossFit (RC) | ||
| Tissue Level | Tissue Level | Tissue Level | ||
| Regular Neck (RN) | Regular Neck (RN) | Regular Neck (RN) | ||
| Wide Neck (WN) | Wide Neck (WN) | |||
| AbutmentCoronalDesign | CADCAM design process. | CADCAM design process. | CADCAM design process. | Identical |
| Designs controlled by material- | Designs controlled by material- | Designs controlled by material- | ||
| specific design limits in the | specific design limits in the | specific design limits in the | ||
| CARES Visual CAD software, | CARES Visual CAD software, | CARES Visual CAD software, | ||
| model verification performed by | model verification performed by | model verification performed by | ||
| the CAM software and milling | the CAM software and milling | the CAM software and milling | ||
| blank dimensions used by theStraumann milling center. | blank dimensions used by theStraumann milling center. | blank dimensions used by theStraumann milling center. | ||
| FEATURE | SUBJECTStraumann® CARES® TANAbutments | PREDICATEStraumann® CARES®Ceramic Abutments(K061277, K072151, K081005) | REFERENCEStraumann® CARES®Titanium Abutments(K052272, K072151, K081005,K082764) | EquivalenceDiscussion |
| CAD DesignLimits | RC, Ø4.1RN, WN platforms:Max. Angulation 30°Emergence Offset 0.1 mmEmergence Angle 65°Min. Thickness 0.4 mmSmooth Distance 0.5 mmNC, Ø3.3RN platforms:Max. Angulation 0°Emergence Offset 0.1 mmEmergence Angle 65°Min. Thickness 0.4 mmSmooth Distance 0.5 mm | All platforms:Max. Angulation 30°Emergence Offset 0.1 mmEmergence Angle 65° | All platforms:Max. Angulation 30°Emergence Offset 0.1 mmEmergence Angle 65°Min. Thickness 0.33 mmSmooth Distance 0.5 mm | EquivalentThe applied limits are identicalwith the exception of minimumwall thickness which is afunction of the materialproperties. The minimum wallthickness for TAN is within therange defined by the ceramicand titanium predicates. |
| DirectlyVeneerable? | Yes | Yes | No | EquivalentThe veneering technique for thesubject devices requires aninitial firing to form the oxidelayer, otherwise it is identical tothat for the ceramic abutments. |
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| Performance Data: | Per Guidance for Industry and FDA Staff - Class II SpecialControls Guidance Document: Root-form Endosseous DentalImplants and Endosseous Dental Abutments dated May 12,2004, the substantial equivalence of the subject device(s) aresatisfactorily addressed via bench studies. Dynamic fatigue testdata consistent with FDA guidance and ISO 14801 have beenprovided in support of this submission. |
|---|---|
| Veneer testing consistent with ISO 9693-1 has been provided insupport of this submission. | |
| Corrosion resistance testing performed per ISO 10271 has beenprovided in support of this submission. | |
| Biocompatibility testing per ISO 10993-5 (cytotoxicity) andISO 10993-18 (chemical analysis) have been submitted insupport of this submission. | |
| Conclusions: | Based upon our assessment of the design and applicableperformance data, the subject devices have been determined tobe substantially equivalent to the identified predicate 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.)