The Straumann® CARES® Screw-retained Bridge Titanium and Straumann® CARES® Dolder® Bar Titanium are indicated for use as bars and bridges that attach to dental implants (Straumann Regular Neck (RN) Ø4.8mm and Wide Neck (WN) Ø6.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The Straumann® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2 to 16 implants.

The Straumann® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10 implants.

Device Description

Straumann CARES Screw-retained Bridge, Titanium (Ti) and Straumann CARES Dolder Bar Titanium (Ti) are dental restorative devices intended to be attached directly to dental implants by basal screws. Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti are designed with implant interfaces comparable to a single tooth abutment which are attached to a Straumann implant with prosthetic platforms Regular Neck (RN) Ø4.8mm and Wide Neck (WN) Ø6.5mm.

The implant positions and oral situation are recognized by a scan of a dental master model with implant analogs and scanbodies. Based on the scan data, the dental technician selects the proper implant interfaces and designs the bar or bridge according to a dentist's prescription. Once the Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti is designed the digital dataset is sent to Straumann CADCAM by internet connection where the bridge or bar is milled from a Titanium-based blank.

Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti allow for individual customization regarding function and esthetics. They attach directly to Straumann dental implants. The device is intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. The devices are CADderived, CAM-produced and have a scanner as its data source.

The milling blanks used for the manufacture of Straumann CARES Screwretained Bridge Ti and Straumann CARES Dolder Bar Ti are manufactured from Titanium, grade 4, which is biocompatible for its intended use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti:

Acceptance Criteria and Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Minimal body testing	Meet or Exceed Predicate Device	Passed
Free hanging bridge	Meet or Exceed Predicate Device	Passed
Free end pontic bridge	Meet or Exceed Predicate Device	Passed
Metal-Ceramic bond testing (ISO 9693)	Requirements Satisfied	Performed (Result not explicitly stated as "Passed" but implied by overall conclusion)

Note: The document states that the Metal-Ceramic bond testing was "in accordance with ISO 9693: Metal-ceramic dental restorative systems: requirements satisfied." The overall conclusion explicitly states that the device "met the pre-determined acceptance criteria," which implies satisfactory results for this test as well.

Study Information

The provided document describes performance testing, primarily bench testing, rather than a clinical study involving human subjects or AI-driven analysis of medical images. Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the type of verification and validation performed for this device.

Here's an breakdown based on the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for the fatigue tests or bond testing. The testing type implies physical samples of the devices were used.
- Data Provenance: Not applicable. The testing was bench testing of manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth in the context of expert review for diagnostic accuracy is not relevant here. The "ground truth" for these performance tests would be the established engineering standards and predicate device performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for establishing ground truth in clinical or diagnostic studies. This document describes mechanical performance testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not done. This device is a physical dental restorative component, not an AI or diagnostic imaging device that uses human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical product, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this performance testing is adherence to established engineering standards (ISO 14801:2007, ISO 9693) and direct comparison to the performance of the legally marketed predicate device. The acceptance criteria explicitly state "Meet or Exceed Predicate Device."
The sample size for the training set:
- Not applicable. This device does not involve machine learning or a training set.
How the ground truth for the training set was established:
- Not applicable. This device does not involve machine learning or a training set.

Summary of the Study:

The study described is a series of bench performance tests to demonstrate the substantial equivalence of the proposed Straumann CARES Screw-retained Bridge Ti and Dolder Bar Ti to their predicate devices. The tests focused on:

Fatigue Testing: Performed according to the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801:2007 ("Dentistry-Implants-Dynamic fatigue test for endosseous dental implants"). This included "Minimal body testing," "Free hanging bridge," and "Free end pontic bridge" configurations. The acceptance criterion for these tests was to "Meet or Exceed Predicate Device," which the proposed devices "Passed."
Metal-Ceramic Bond Testing: Performed in accordance with ISO 9693 ("Metal-ceramic dental restorative systems: requirements satisfied"). The document states the requirements were satisfied.

The conclusion drawn from this performance testing was that the devices "function as intended and met the pre-determined acceptance criteria," indicating substantial equivalence to the predicate device and confirming their safety and effectiveness for intended use.

Summary

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K//2280
NOV 16 2011

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510(k) Summary

1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 800-448-8168, ext 2513 Telephone Number: Fax Number: 978-747-0023 Contact Person: Elaine Alan Senior Regulatory Affairs Specialist

1. Date of Submission: August 8, 2011

3. Name of the Device

Straumann® CARES® Screw-retained Bridge Ti Trade Name: Straumann® CARES® Dolder® Bar Ti Common Name: Implant Bridge Classification Name: Endosseous Dental Implant Abutment Regulation Number: $872.3630

1. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
- K101465, Straumann® CARES® Screw-retained Bridge and . Straumann® CARES® Dolder® Bar

5. Description of the Device

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6. Intended Use

Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti are indicated for use as bars and bridges that attach to dental implants (Straumann implant Regular Neck (RN) Ø4.8mm and Wide Neck (WN) Ø6.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The Straumann CARES Screw-retained Bridge Ti can be designed for specific patient sizes and spans that are attached to 2 to16 implants.

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The Straumann CARES Dolder Bar Ti can be designed for specific patient sizes and spans that are attached to 2 to 10 implants.

7. Technological Characteristics

The Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti are equivalent to the predicate device in design, fundamental operating principles, and intended use. Table 1 compares the Straumann CARES Screw-retained Bridge and Straumann CARES Dolder Bar to the predicate device. The proposed devices are milled from blank discs of Titanium, grade 4, which is widely used in the medical industry and is well known to be biocompatible. The Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti are designed using Straumann's CAD designing software, Straumann CARES® Visual®, and CAM milled at Straumann's central milling centers. This is the identical CADCAM designing and milling process as the predicate device.

Table 1: Comparison Matrix

Feature	Proposed DeviceStraumann CARES Screw-retainedBridge Ti andStraumann CARES Dolder Bar Ti	Predicate DeviceStraumann CARES Screw-retainedBridge andStraumann CARES Dolder Bar
510(k) Number	Subject Submission	K101465
Intended Use	Same	The Straumann® CARES® Screw-retained Bridge and Straumann®CARES® Dolder® Bar are indicatedfor use as bars and bridges thatattach to dental implants (StraumannRegular Neck (RN) Ø4.8mm andWide Neck (WN) Ø6.5mm) in thetreatment of partially or totallyedentulous jaws for the purpose ofrestoring chewing function.The Straumann CARES® Screw-retained Bridge is available indifferent sizes and spans and can befitted on 2 to 16 implants.The Straumann CARES Dolder Bar

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Feature	Proposed Device	Predicate Device
	Straumann CARES Screw-retainedBridge Ti andStraumann CARES Dolder Bar Ti	Straumann CARES Screw-retainedBridge andStraumann CARES Dolder Bar
Material	Titanium, grade 4	Coron, Cobalt-Chromium alloy
ImplantCompatibility	same	Straumann Regular Neck (RN)Ø4.8mm and Wide Neck (WN)Ø6.5mm
DesignSoftware	Same	Straumann CARES Visual
Basal Screw	Same	Titanium Alloy, Ti6Al7Nb

The proposed devices are substantially equivalent to the currently marketed predicate devices.

8. Performance Testing

Verification and validation testing were performed to ensure that the devices subject to this 510(k) Premarket Notification function as intended and that design input matches design output. Testing included:

1. Performance Testing
- i. Fatigue Testing was performed utilizing pertinent testing procedures defined in the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and ISO 14801:2007, "Dentistry-Implants-Dynamic fatigue test for endosseous dental implants." Table 2 lists tests performed and results.

Test Performed	Acceptance Criteria	Result
Minimal body testing	Meet or ExceedPredicate Device	Passed
Free hanging bridge	Meet or ExceedPredicate Device	Passed
Free end pontic bridge	Meet or ExceedPredicate Device	Passed

Table 2

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ii. Metal-Ceramic bond testing in accordance with ISO 9693: Metal-ceramic dental restorative systems: requirements satisfied.

Conclusion 9.

The results from the testing conducted demonstrated that the Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti functions as intended and met the pre-determined acceptance criteria.

The Straumann CARES Screw-retained Bridge Ti and Straumann CARES Dolder Bar Ti is a validated device. The results of the performance bench testing and risk analysis indicate that the Straumann CARES Screwretained Bridge Ti and Straumann CARES Dolder Bar Ti is substantially equivalent to the identified predicate device and is safe and effective for its intended use.

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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is likely part of a document or presentation.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV 1 6 2011

Ms.Elaine Alan Senior Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810 `

Re: K112280

Trade/Device Name: Straumann® CARES® Screw-retained Bridge Titanium Straumann® CARES® Dolder® Bar Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2011 Received: October 17, 2011

Dear Ms. Alan:

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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Page 2 – Ms. Alan

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K/12280

Indications for Use

510(k) Number (if known):

Device Name: Straumann® CARES® Screw-retained Bridge Titanium Straumann® CARES® Dolder® Bar Titanium

Indications for Use:

The Straumann® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2 to 16 implants.

The Straumann® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10 implants.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of DCRH, Office of Device Evaluation (ODE)

Susan Turner

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112081

510(k): Straumann SRBB Titanium

Regulation Number and Section

§ 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.)