Straumann CARES Titanium Alloy (TAN) Abutment
Device Facts
| Record ID | K150899 |
|---|---|
| Device Name | Straumann CARES Titanium Alloy (TAN) Abutment |
| Applicant | Straumann USA, LLC |
| Product Code | NHA · Dental |
| Decision Date | Sep 16, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Indications for Use
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. Prosthetic components connected to the implant are intended for use as an aid in prosthetic rehabilitation.
Device Story
Straumann CARES TAN Abutments are customized dental abutments for endosseous dental implants. Input data consists of either traditional wax-up abutment scans or intraoral scans. Design is performed using Straumann CARES Visual CAD software, which enforces material-specific design limits (angulation, thickness, emergence). Design data is transmitted to a Straumann milling center for fabrication. The device is used by dental professionals in clinical settings to support crowns, bridges, or overdentures. The abutments can be cemented or directly veneered. The device benefits patients by providing a customized, functional, and esthetic prosthetic interface for dental implants.
Clinical Evidence
Bench testing only. Evidence includes dynamic fatigue testing per ISO 14801, veneer testing per ISO 9693-1, and corrosion resistance testing per ISO 10271. Biocompatibility testing includes cytotoxicity (ISO 10993-5) and chemical analysis (ISO 10993-18).
Technological Characteristics
Material: Titanium-6aluminum-7niobium alloy (TAN) per ISO 5832-11. Design: CAD/CAM customized. Platforms: Bone Level (NC, RC) and Tissue Level (RN, WN). Manufacturing: Milling center fabrication based on software-controlled design limits. Connectivity: Digital design data transfer.
Indications for Use
Indicated for single tooth replacement and multiple tooth restorations in patients requiring prosthetic rehabilitation via dental implants.
Regulatory Classification
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.
Special Controls
*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.)
Predicate Devices
- Straumann RN CARES Ceramic Coping (K061277)
- P.004 RC CARES Titanium and Ceramic Abutment (K072151)
- P.004 NC CARES Titanium and Ceramic Abutment (K081005)
Reference Devices
Submission Summary (Full Text)
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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)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk<br>Director of Regulatory Affairs and Clinical Research |
| Date Prepared: | August 29, 2015 |
| Product Code(s): | NHA (21 CFR 872.3630) |
| Device Class: | II<br>(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 Predicate<br>Device: | K061277 - Straumann RN CARES Ceramic Coping |
| Reference Predicate<br>Device(s): | K072151 – P.004 RC CARES Titanium and Ceramic Abutment<br>K081005 – P.004 NC CARES Titanium and Ceramic Abutment |
| Reference Device(s): | K052272 – Straumann RN CARES Titanium Abutment<br>K082764 – Straumann CARES WN Titanium Coping |
| Device Description: | Straumann® CARES® TAN Abutments are used for the<br>restoration of Straumann dental implants of different types,<br>endosteal diameters, lengths. The abutments are available with<br>interface geometry compatible with the bone level NC (3.3 mm)<br>and RC (4.1 mm) and the tissue level RN (3.3 mm, 4.1 mm) and<br>WN (4.8 mm) implants. The proposed CARES® TAN<br>abutments are provided in a set that contains the individualized<br>abutment and a corresponding basal screw.<br>The Straumann CARES TAN Abutments allow for individual<br>customization regarding function and esthetics. Straumann<br>CARES TAN Abutments are designed by the customer either<br>by 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:
| | Predicate<br>Ceramic | Subject<br>TAN<br>RC, RN 4.1, WN | Subject<br>TAN<br>NC, RN 3.3 |
|---------------------|----------------------|----------------------------------|------------------------------|
| Parameter | Limit | Limit | Limit |
| Max.<br>Angulation | 30° | 30° | 0° |
| Emergence<br>Offset | 0.1 mm | 0.1 mm | 0.1 mm |
| Emergence<br>Angle | 65° | 65° | 65° |
| Min.<br>Thickness | 0.5 mm | 0.4 mm | 0.4 mm |
| Smooth<br>Distance | 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 | SUBJECT<br>Straumann® CARES® TAN<br>Abutments | PREDICATE<br>Straumann® CARES®<br>Ceramic Abutments<br>(K061277, K072151, K081005) | REFERENCE<br>Straumann® CARES®<br>Titanium Abutments<br>(K052272, K072151, K081005,<br>K082764) | Equivalence<br>Discussion |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for | The Straumann CARES® TAN | Abutments are placed into the | Abutments are placed into the | Equivalent |
| Use | abutments are indicated for<br>single tooth replacement and<br>multiple tooth restorations. The<br>prosthetic restoration can be<br>cemented or directly veneered/<br>screw-retained. | dental implants to provide<br>support for prosthetic restoration<br>such as crowns, bridges and<br>overdentures.<br>The P.004 NC CARES Ceramic<br>Abutment is indicated for single<br>tooth replacements and multiple<br>tooth restorations. The<br>prosthetic restoration can be<br>cemented or directly<br>veneered/screw retained. | dental implants to provide<br>support for prosthetic restoration<br>such as crowns, bridges and<br>overdentures.<br>The P.004 NC CARES Titanium<br>Abutment is indicated for<br>cemented restoration. The<br>abutment can be used in single<br>tooth replacements and multiple<br>tooth restorations. | The indicated uses of the subject<br>and ceramic predicate devices<br>are equivalent, including the<br>ability to be directly veneered;<br>the opening paragraph for the<br>ceramic abutments does not<br>materially change the<br>indications.<br>The predicate titanium<br>abutments are not indicated for<br>direct veneering. |
| Abutment | Titanium-Aluminum-Niobium | Zirconium dioxide ceramic | Commercially pure grade 4 | Equivalent |
| Material | alloy (Ti-6Al-7Nb, TAN) | (ZrO2) | titanium | Different materials, both<br>meeting accepted standards for<br>use in dental restorations |
| FEATURE | SUBJECT<br>Straumann® CARES® TAN<br>Abutments | PREDICATE<br>Straumann® CARES®<br>Ceramic Abutments<br>(K061277, K072151, K081005) | REFERENCE<br>Straumann® CARES®<br>Titanium Abutments<br>(K052272, K072151, K081005,<br>K082764) | Equivalence<br>Discussion |
| Abutment<br>Apical<br>Design | Engaging | Engaging | Engaging | Equivalent |
| | BoneLevel | BoneLevel | BoneLevel | The subject TAN abutments<br>employ the same implant-to-<br>abutment platforms as the<br>titanium predicates. The<br>ceramic predicates do not<br>include 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) | |
| Abutment<br>Coronal<br>Design | 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 the<br>Straumann milling center. | blank dimensions used by the<br>Straumann milling center. | blank dimensions used by the<br>Straumann milling center. | |
| FEATURE | SUBJECT<br>Straumann® CARES® TAN<br>Abutments | PREDICATE<br>Straumann® CARES®<br>Ceramic Abutments<br>(K061277, K072151, K081005) | REFERENCE<br>Straumann® CARES®<br>Titanium Abutments<br>(K052272, K072151, K081005,<br>K082764) | Equivalence<br>Discussion |
| CAD Design<br>Limits | RC, Ø4.1RN, WN platforms:<br>Max. Angulation 30°<br>Emergence Offset 0.1 mm<br>Emergence Angle 65°<br>Min. Thickness 0.4 mm<br>Smooth Distance 0.5 mm<br><br>NC, Ø3.3RN platforms:<br>Max. Angulation 0°<br>Emergence Offset 0.1 mm<br>Emergence Angle 65°<br>Min. Thickness 0.4 mm<br>Smooth Distance 0.5 mm | All platforms:<br>Max. Angulation 30°<br>Emergence Offset 0.1 mm<br>Emergence Angle 65°<br> | All platforms:<br>Max. Angulation 30°<br>Emergence Offset 0.1 mm<br>Emergence Angle 65°<br>Min. Thickness 0.33 mm<br>Smooth Distance 0.5 mm | Equivalent<br>The applied limits are identical<br>with the exception of minimum<br>wall thickness which is a<br>function of the material<br>properties. The minimum wall<br>thickness for TAN is within the<br>range defined by the ceramic<br>and titanium predicates. |
| Directly<br>Veneerable? | Yes | Yes | No | Equivalent<br>The veneering technique for the<br>subject devices requires an<br>initial firing to form the oxide<br>layer, otherwise it is identical to<br>that for the ceramic abutments. |
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| Performance Data: | Per Guidance for Industry and FDA Staff - Class II Special<br>Controls Guidance Document: Root-form Endosseous Dental<br>Implants and Endosseous Dental Abutments dated May 12,<br>2004, the substantial equivalence of the subject device(s) are<br>satisfactorily addressed via bench studies. Dynamic fatigue test<br>data consistent with FDA guidance and ISO 14801 have been<br>provided in support of this submission. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Veneer testing consistent with ISO 9693-1 has been provided in<br>support of this submission. |
| | Corrosion resistance testing performed per ISO 10271 has been<br>provided in support of this submission. |
| | Biocompatibility testing per ISO 10993-5 (cytotoxicity) and<br>ISO 10993-18 (chemical analysis) have been submitted in<br>support of this submission. |
| Conclusions: | Based upon our assessment of the design and applicable<br>performance data, the subject devices have been determined to<br>be substantially equivalent to the identified predicate devices. |
