(107 days)
The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
Straumann® CARES® Abutments CoCr are used for the restoration of Straumann dental implant platforms RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). The Straumann® CARES® Abutments CoCr allow for individual customization regarding function and esthetics. Straumann® CARES® Abutments CoCr are designed by the dental laboratory technician either by means of a conventional wax-up model that is subsequently scanned or by scanning the intraoral situation and designing the shape by using a Straumann-approved software (such as Straumann® CARES® Visual). The design data is then transferred to a Straumann central milling center where the fabrication of the customized abutment is carried out. The Straumann® CARES® Abutments CoCr can be directly veneered.
The provided text describes the regulatory filing for a dental implant abutment and does not contain information about an AI/ML device. Therefore, it's not possible to extract the requested details regarding acceptance criteria, study design for AI models, or expert ground-truthing. The document pertains to a traditional medical device (Straumann® CARES® Abutments CoCr) and its equivalence to predicate devices based on material, design, and mechanical performance testing.
However, I can extract the acceptance criteria and performance data for the traditional medical device as described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Device Performance |
|---|---|
| Material Composition | The Cobalt-chromium alloy (coron) used meets the requirements of ISO 22674 Type 4. |
| Dynamic Fatigue | Tested according to ISO 14801 "Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Performance deemed "Equivalent" to predicate devices. Specific quantitative results (e.g., fatigue strength at N cycles) are not provided in this summary. |
| Biocompatibility | Demonstrated by testing according to:- ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"- ISO 10993-5:2009 "Tests for in vitro cytotoxicity"- ISO 10993-18 "Chemical characterization of materials" |
| Veneering Performance | Performed per ISO 9693-1 "Dentistry – Compatibility testing – Part 1: Metal ceramic systems". |
| Corrosion Resistance | Demonstrated according to ISO 10271:2011 "Corrosion test methods for metallic materials". |
| Sterilization Validation | Carried out via the overkill method, 1/2 cycle, to a Sterilization Assurance Level (SAL) of 10^-6 in accordance to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2. |
| Design Limits | Max Angulation 30°, Minimum thickness 0.33mm. Minimum surface area requirements based on tooth position were also identical to the predicate. |
The following information is not present in the provided document, as it describes a non-AI medical device:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
Additional Study Information (from the document for the traditional device):
- Study Type: Bench testing (mechanical, material, biocompatibility, corrosion, sterilization).
- Clinical Studies: "No animal or human clinical studies were conducted."
- Ground Truth: For traditional device testing, "ground truth" is typically defined by established engineering and material science standards (e.g., ISO, ASTM) and manufacturing specifications.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 3, 2018
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K172798
Trade/Device Name: Straumann® CARES® Abutments CoCr Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 4, 2017 Received: December 5, 2017
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
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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Indications for Use
510(k) Number (if known) K172798p here to enter text
Device Name
Straumann® CARES® Abutments CoCr
Indications for Use (Describe)
The Straumann® CARES® Abutments CoCr 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)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary1. | 510(k) Number: K172798 |
|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052 |
| Contact Person: | Jennifer M. Jackson, MSDirector of Regulatory Affairs and Quality+1 (978) 747-2509 |
| Prepared By & SecondaryContact: | Shokoufeh KhodabandehRegulatory Affairs and Compliance ManagerInstitut Straumann AG+41 61 965 1260 |
| Date Prepared: | January 3, 2018 |
| Product Code(s): | NHA |
| Device Class: | II |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Common Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Proprietary Name:Predicate Device(s): | Straumann® CARES® Abutments CoCrK150899 Straumann® CARES® Titanium Alloy (TAN) Abutments;Manufacturer Straumann |
| Reference Device(s): | K132844Straumann® CARES® SRBB; Manufacturer StraumannK101465 Straumann® CARES® Bridge, Straumann® CARES®Bar ; Manufacturer StraumannK083550 Modified S/SP/BL 3.3 Implants;Manufacturer StraumannK150203 Medentika CAD/CAM Abutments; Manufacturer MedentikaGmbhK162890 Small Diameter Implant (SDI); Manufacturer StraumannK062129 Straumann Dental Implant System: P.004 Implants;Manufacturer Straumann |
| Device Description: | Straumann® CARES® Abutments CoCr are used for the restorationof Straumann dental implant platforms RN (Regular Neck), WN(Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). TheStraumann® CARES® Abutments CoCr allow for individualcustomization regarding function and esthetics. Straumann®CARES® Abutments CoCr are designed by the dental laboratorytechnician either by means of a conventional wax-up model that issubsequently scanned or by scanning the intraoral situation anddesigning the shape by using a Straumann-approved software (suchas Straumann® CARES® Visual). The design data is thentransferred to a Straumann central milling center where thefabrication of the customized abutment is carried out.The Straumann® CARES® Abutments CoCr can be directlyveneered. |
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| Indications For Use: | The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.. |
|---|---|
| Materials: | Straumann CARES Abutments CoCr: cobalt-chromium based dental alloy, trade named coron. This material is identical to the coron material used in Straumann® CARES® SRBB (K132844 and K101465). Straumann Basal Screw: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The basal screw component of the Straumann® CARES® Abutments CoCr are identical to the basal screw components of the Straumann predicates (K150899, K041295, K071357, and K062129 ). |
| Technological Characteristics: | A comparison of the relevant technological characteristics between the subject and the primary predicate is provided in the table that follows. |
| Feature | Subject DeviceStraumann® CARES® AbutmentsCoCr | Primary Predicate DevicesStraumann® CARES® TitaniumAlloy (TAN) Abutments(K150899) | EquivalenceDiscussion |
|---|---|---|---|
| Indication foruse | The Straumann® CARES®Abutments CoCr are indicated forsingle tooth replacement andmultiple tooth restorations. Theprosthetic restoration can becemented or directlyveneered/screw-retained. | The Straumann® CARES®Abutments TAN are indicated forsingle tooth replacement andmultiple tooth restorations. Theprosthetic restoration can becemented or directlyveneered/screw-retained. | Identical |
| CompatibleImplants | Straumann Bone Level implantshaving the NC and RC implant-to-abutment interface geometries.Straumann Tissue Level implantshaving the RN and WN implant-to-abutment interface geometries. | Straumann Bone Level implantshaving the NC and RC implant-to-abutment interface geometries.Straumann Tissue Level implantshaving the NN, RN, WN implant-to-abutment interface geometries. | Identical |
| Material | CARES abutment: Cobalt-chromiumAlloy (coron)Basal screw: Titanium alloy(Ti6Al7Nb), TAN | CARES abutment: Titanium alloy(Ti6Al7Nb), TANBasal screw: Titanium alloy(Ti6Al7Nb), TAN | Equivalent |
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| Feature | Subject DeviceStraumann® CARES® AbutmentsCoCr | Primary Predicate DevicesStraumann® CARES® TitaniumAlloy (TAN) Abutments(K150899) | EquivalenceDiscussion | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DesignLimits: | Max. Angulation 30°Minimum thickness 0.33 mm Tooth Position Minimumsurfacearea mm² 7,10, 24,25 37 4,5,12,1320,21,28,29 47 26,11,2,27,8,9 43 1-3, 14-16, 17-19,30-32 56 | Max. Angulation 30°Minimum thickness 0.33mm Tooth Position Minimumsurfacearea mm² 7,10, 24,25 37 4,5,12,1320,21,28,29 47 26,11,2,27,8,9 43 1-3, 14-16, 17-19,30-32 56 | Identical | ||||||||||||||||||||
| Construction | One-piece solid Abutment suppliedwith the compatible basal screw | One-piece solid abutment suppliedwith the compatible basal screw | Identical | ||||||||||||||||||||
| Packaging | The abutment in reclosable poly bagand the corresponding basal screw isindividually packed in a blister,co-packaged in a craft board box | The abutment in reclosable polybag and the corresponding basalscrew is individually packed in ablister, co-packaged in a craftboard box. | Identical | ||||||||||||||||||||
| Sterility | Provided non-sterile.To be sterilized by the user in asteam autoclave process. | Provided non-sterile.To be sterilized by the user in asteam autoclave process. | Identical | ||||||||||||||||||||
| Fatigueperformance | Tested according to ISO 14801 | Tested according to ISO 14801 | Equivalent |
Performance Data: The material used in the manufacture of Straumann® CARES® Abutments CoCr is a cobalt-chromium alloy which meets the requirements of ISO 22674 type 4. Bench testing was performed to evaluate the performance of the proposed Straumann® CARES® Abutments CoCr. Dynamic fatigue tests were conducted according to the ISO 14801 "Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The biocompatibility of the subject device is demonstrated by "Biological evaluation of
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medical devices - Part 1: Evaluation and testing within a risk management process", ISO 10993-5:2009 "Tests for in vitro cytotoxicity", and ISO 10993-18 "Chemical characterization of materials". Veneering performance testing of the Straumann CoCr alloy (coron) has been performed per ISO 9693-1, Dentistry – Compatibility testing – Part 1: Metal ceramic systems; A final workflow validation according to internal procedures has also been conducted. Corrosion resistance was demonstrated according to ISO 10271:2011 – "Corrosion test methods for metallic materials". Sterilization validation was carried out via the overkill method, 1/2 cycle, to a Sterilization Assurance Level (SAL) of 10-6 in accordance to the ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2.
No animal or human clinical studies were conducted.
Conclusions: Based upon our assessment of the design and applicable performance data, the subiect devices have been determined to be 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.)