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

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

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

Device Description

Straumann® CARES® Screw-Retained Bridges and Straumann® CARES® Dolder® Bars are dental restorative devices intended to be attached directly to dental implants by basel screws. The Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are designed with implant interfaces comparable to a single tooth abutment which are attached to a Straumann implant RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm.

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 or Straumann CARES Dolder Bar is designed, the digital dataset is sent to Straumann CADCAM by an internet connection where the bridge or bar is milled from a cobaltchromium-based blank.

Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars 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 CAD-derived, CAMproduced and have a scanner as its data source.

The milling blanks used for the manufacture of Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are manufactured from a cobalt chromium base metal alloy, which has been tested and found biocompatible for its intended use. The cobalt chromium alloy meets the physical and mechanical requirements of ISO 22674, Dentistry - Metallic materials for fixed and removable restorations and appliances and ISO 9693, Metal-ceramic dental restorative systems.

AI/ML Overview

The provided 510(k) summary for the Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar describes non-clinical testing to demonstrate substantial equivalence to predicate devices. This submission focuses on material properties, biocompatibility, and mechanical performance rather than AI-driven insights or diagnostic accuracy. Therefore, many standard AI/ML study components, such as sample size for test/training sets, expert qualifications for ground truth, adjudication methods, and MRMC studies, are not applicable here.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance are presented in several tables within the document for different aspects of the device.

Table 1: Metallic Material Properties (Derived from Table 2 in document)

Property	Unit	Acceptance Criteria with and without Thermal Treatment	Conclusion
Color	na	Silver gray	Passed
Density	g/cm³	8.3	Passed
Solubility in water	mg/l	insoluble	Passed
Proof strength Rp0.2	MPa	> 360	Passed
Vickers hardness	HV10	260	na
Elongation after fracture	%	> 2.0	Passed
CTE (25-500°C)	10-6 K-1	14.4	na
Solidus	°C	1320	na
Liquidus	°C	1420	na

Table 2: Ceramic Bonding Properties (Derived from Table 3 in document)

Veneering Porcelain	Debonding/Crack-Initiation Strength $\tau_b$ [MPa]	Acceptance Criterion	Conclusion
Initial MC (GC)	> 25 MPa	N/A (implied from results)	Passed
IPS InLine (Ivoclar Vivadent)	> 25 MPa	N/A (implied from results)	Passed
HeraCeram (Heraeus Kulzer)	> 25 MPa	N/A (implied from results)	Passed
VM13 (Vita Zahnfabrik)	> 25 MPa	N/A (implied from results)	Passed

Table 3: Biocompatibility Testing (Derived from Table 4 in document)

Test Method	Biocompatibility Acceptance Criteria	Results
Cytotoxicity of extract	< 30 %	Passed
Organic leachables qualitative	na	na
Leachables quantitative	na	na

Table 4: Static Corrosion Testing (Derived from Table 5 in document)

Composite Material	Units	Acceptance Criterion	Results
Cobalt (Co)	µg/cm²	≤ 100	Passed
Chromium (Cr)	µg/cm²	≤ 100	Passed
Aluminum (Al)	µg/cm²	≤ 100	Passed
Titanium (Ti)	µg/cm²	≤ 100	Passed
Niobium (Nb)	µg/cm²	≤ 100	Passed
Tungsten (W)	µg/cm²	≤ 100	Passed
Silicon (Si)	µg/cm²	≤ 100	Passed
Manganese (Mn)	µg/cm²	≤ 100	Passed
Iron (Fe)	µg/cm²	≤ 100	Passed
Beryllium (Be)	µg/cm²	≤ 100	Passed
Cadmium (Cd)	µg/cm²	≤ 100	Passed

Table 5: Dynamic Fatigue Testing (Derived from Table 6 in document)

Composite Material	Results
Minimal body testing (Connection testing)	Passed
Free hanging bridge (Connector testing)	Passed
Free end pontic bridge (Connector testing)	Passed

2. Sample size used for the test set and the data provenance

The document specifies "Non-Clinical Testing" was performed. However, it does not specify the sample size for individual tests (e.g., number of samples for proof strength, number of samples for cytotoxicity). It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as the testing is related to manufacturing material properties, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. The "ground truth" here is based on internationally recognized standards (ISO 22674, ISO 9693) and established material science and biocompatibility testing methodologies, not expert interpretation of medical images or patient records. The results are quantitative measurements against predefined criteria.

4. Adjudication method for the test set

This is not applicable as the tests involve objective, quantitative measurements against predefined criteria, not subjective interpretations requiring adjudication.

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 is not applicable. This submission is for a medical device (dental bridge/bar) and its material properties and manufacturing process, not an AI/ML diagnostic or assistive device. There are no "human readers" or AI assistance involved in the described testing.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an implantable dental restoration, not an algorithm. While CADCAM software is used in its design, the testing performed is for the physical product, not the standalone performance of the software as a diagnostic or AI tool. The document states: "Validation of the CARES Visual CAD software provides evidence that design parameters for the Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars have met their pre-determined acceptance criteria and that dental restorations meeting their design specifications can be manufactured by Straumann CAM milling devices." This refers to the software's ability to produce designs that meet specifications for manufacturing, not its "standalone performance" in an AI/ML context.

7. The type of ground truth used

The ground truth used for this submission is based on:

International Standards: ISO 22674 (Dentistry - Metallic materials for fixed and removable restorations and appliances) and ISO 9693 (Metal-ceramic dental restorative systems) for physical and mechanical requirements.
Biocompatibility Standards: Implicitly, standards related to biocompatibility testing for medical devices.
Established Material Science Metrics: Specific quantifiable parameters like density, proof strength, elongation, corrosion rates, and cytotoxicity.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of material and device performance testing for a traditional medical device like this, which is not an AI/ML product.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

Summary

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K101465

DEC 1 3 2010

510(k) SUMMARY

Submitter
Company:	Institut Straumann AG
Street:	Peter Merian-Weg 12
ZIP-Code, City:	CH-4002 Basel
Federal State:	Basel-City
Country:	Switzerland
Establishment Registration Number:	9613348
Official Correspondent:	Dr. Toni K. Joergensen,Head of Corporate Regulatory AffairsInstitut Straumann AG
Phone:	+41 61 965 14 12
Fax:	+41 61 965 11 02
E-mail:	Toni.Joergensen@Straumann.com
Submitter:	Dr. Andreas Petermann,Head of Regulatory AffairsStraumann CADCAM GmbH
Phone:	+49-89-30 90 75 191
Fax:	+49-89-30 90 75 119
E-mail:	Andreas.Petermann@Straumann.com
Date:	November 23, 2010
Name of Device
Proprietary Name:	Straumann® CARES® Screw-Retained BridgeStraumann® CARES® Dolder® Bar
Classification Name	Endosseous Dental Implant Abutment
Common Name:	Implant Bridge
Regulation Number and Product Code
Regulation Number:	21 C.F.R § 872.3630
Product Code:	76 NHA

ﻠﺴﻨﺔ

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K101465

Predicate Devices

Procera Implant Bridge Overdenture ........................................................................................................................................... Procera Implant Bridge ....................................................................................................................................................... ETKON ES1, MODEL 019.0001, ETKON VISUAL, K093113 STRAUMANN CADCAM ABUTMENT

Device Description

Image /page/1/Picture/5 description: The image shows a round object with a complex structure on top. The object appears to be made of a rough, textured material. The structure on top consists of interconnected elements, possibly metallic, forming a network of lines and shapes. The lighting in the image is somewhat diffused, creating shadows and highlights that emphasize the texture of the object and the complexity of the structure.

Example screw retained bar to be mounted on 5 dental implants (may be fixed on 2 to 10 implants)

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K101465

Image /page/2/Picture/1 description: The image shows a dental impression. The impression is made of a pink material and is of the upper teeth. The impression is set in a tray and is ready to be used to create a model of the teeth.

Example screw retained bridge to be mounted on 5 dental implants (may be fixed on 2 to 16 implants)

The milling blanks used for the manufacture of Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are manufactured from a cobalt chromium base metal alloy, which has been tested and

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found biocompatible for its intended use. The cobalt chromium alloy meets the physical and mechanical requirements of ISO 22674, Dentistry - Metallic materials for fixed and removable restorations and appliances and ISO 9693, Metal-ceramic dental restorative systems.

Intended Use

The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The Straumann CARES Screw-Retained Bridge can be designed for specific patient sizes and spans that are attached to 2 to 16 implants.

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

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K101465

Technical Comparison to the Predicate Device

The Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars are equivalent in design and materials to the predicate device.

Table 1 compares the Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars to the predicate devices:

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Table 1

Characteristic	Straumann CARES®Screw-Retained BridgeStraumann CARESDolder® Bar	Procera Implant BridgeK041236, K090069
Indications for Use	Indicated for use as ascrew retained bridge orbar framework in thetreatment of partially ortotally edentulous jawsfor the purpose ofrestoring chewingfunction.	Same
Intended Use	Intended to be finishedinto a bridge oroverdenture usingstandard dentallaboratory techniques andmaterials.	Same
Connection Type	Screw retained dentalrestorations	Same
Connection Level	Dental implant	Same
Implant Interface Type	Straumann® RN (RegularNeck) Ø 4.8 mm and WN(Wide Neck) Ø 6.5 mm	Procera and Straumann(RN (Regular Neck) Ø 4.8mm and WN (Wide Neck)Ø 6.5 mm) implantinterface type
Design Parameters	3D scan and CAD	Same
Manufacturing Method	CADCAM milling frommilling blanks	Same
Material (bar and bridge)	chromium/cobalt dentalalloy	titanium (K041236)titanium,titanium/vanadium alloy,or chromium/cobalt alloy(K090069)
Finishing Method	Bridge: intended to befinished into a bridge byapplication of a veneeringporcelain layer.Bar: intended to befinished into overdentureusing standard dentallaboratory techniques andmaterials.	Same

Cobalt/chromium alloys are widely used in dentistry as non-precious dental alloy for cast and CADCAM fabrication of cementable crowns and

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bridges. Such alloys are regulated by 21CFR872.3710, product code EJH and are exempt from 510(k) requirements.

Non-Clinical Testing

Table 2 summarizes the metallic material properties of the Straumann CARES Screw-Retained Bridge and Dolder Bar.

Table 2

Property	Unit	Acceptance criteriawith and withoutthermal treatment	Conclusion
Color	na3	Silver gray	passed
Density	g/cm³	8.3	passed
Solubility in water	mg/l	insoluble	passed
Proof strength Rp0.2	MPa	> 360	passed
Vickers hardness	HV10	260	na
Elongation afterfracture	%	> 2.0	passed
CTE (25-500°C)	10-6K-1	14.4	na
Solidus	°C	1320	na
Liquidus	°C	1420	na

3 na is a notation for not applicable

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Table 3 summaries the ceramic bonding properties of the Straumann CARES Screw-Retained Bridge and Dolder Bar.

Table 3

Veneering porcelain	Debonding/crack-initiation strength $\tau_b$[MPa]	Conclusion
Initial MC (GC)	> 25 MPa	passed
IPS InLine (Ivoclar Vivadent)	> 25 MPa	passed
HeraCeram (Heraeus Kulzer)	> 25 MPa	passed
VM13 (Vita Zahnfabrik)	> 25 MPa	passed

Table 4 summaries the biocompatibility testing performed on the Straumann CARES Screw-Retained Bridge and Dolder Bar.

Table 4

Test Method	BiocompatibilityAcceptancecriteria	Results
Cytotoxicity of extract	< 30 %	passed
Organic leachablesqualitative	na4	na
Leachables quantitative	na	na

4 na is a notation for not applicable

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Table 5 summaries the static corrosion testing performed on the Straumann CARES Screw-Retained Bridge and Dolder Bar.

Table 5

CompositeMaterial	Units	AcceptanceCriterion	Results
Cobalt (Co)	µg/cm²	≤ 100	passed
Chromium (Cr)	µg/cm²	≤ 100	passed
Aluminum (Al)	µg/cm²	≤ 100	passed
Titanium (Ti)	µg/cm²	≤ 100	passed
Niobium (Nb)	µg/cm²	≤ 100	passed
Tungsten (W)	µg/cm²	≤ 100	passed
Silicon (Si)	µg/cm²	≤ 100	passed
Manganese (Mn)	µg/cm²	≤ 100	passed
Iron (Fe)	µg/cm²	≤ 100	passed
Beryllium (Be)	µg/cm²	≤ 100	passed
Cadmium (Cd)	µg/cm²	≤ 100	passed

Table 6 summarizes the dynamic fatigue testing performed on the Straumann CARES Screw-Retained Bridge and Dolder Bar.

Table 6

Composite Material	Results
Minimal body testing(Connection testing)	passed
Free hanging bridge(Connector testing)	passed
Free end pontic bridge(Connector testing)	passed

Validation of the CARES Visual CAD software provides evidence that design parameters for the Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars have met their pre-determined acceptance criteria and that dental restorations meeting their design specifications can be manufactured by Straumann CAM milling devices

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14101465

Conclusion

Non-clinical testing presented in this 510(k) demonstrate that the Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder® Bar met predefined acceptance criteria and successfully passed verification and validation testing. The information presented in this 510(k) demonstrated that the Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder® Bar are substantially equivalent to the predicate device.

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Image /page/10/Picture/1 description: The image shows a logo with two distinct parts. On the left is a circular seal with text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA". To the right of the seal is a stylized graphic that resembles three curved lines or waves stacked on top of each other. The graphic is black and stands out against the white background.

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

Institut Straumann AG C/O Ms. Janet Kay Regulatory and Clinical Affairs Director Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

DEC 1 3 2010

Re: K101465

K101465
Trade/Device Name: Straumann® CARES® Screw-retained Bridge Straumann® CARES® Dolder Bar Regulation Number: 21 CFR. 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 6, 2010 Received: December 7, 2010

Dear Ms. Kay:

We have reviewed your Section 510(k) premarket notification of intent to market the device t We have reviewed your Section 310(x) presidentially equivalent (for the referenced above and have declinities mo to hegally marketed predicate devices marketed in
indications for use stated in the mC00sure) to tegans data of the Medical Device indications for use stated in the enclosers, we cenactment date of the Medical Device interstate comments, or to way 20, 1770, can reclassified in accordance with the provisions of Amendments, or to devices that have been roads and require approval of a premaint
the Federal Food, Drug, and Cosmetic Act (Act) that do subject to the general the Federal Food, Drug, and Cosmetic Act (rec) that evice, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the general approval application (FMA). Tou may, moreontrols provisions of the Act include controls provisions of the Act. The genting of devices, good manufacturing practice, requirements for annual registration, institution good on . Please note: CDRH doss
labeling, and prohibitions against misbranding and adulteration. Please notes on thougher labeling, and pronibilions against insults and and in a remind you, however,
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
ns affective and the states to the Frinting major requlations affecting w If your device is classified (see above) mo only. Fassing major regulations affecting your
(PMA), it may be subject to additional controls. Title 21, Parts 800 to 898 , In (PMA), it may be subject to adultional controllations. Title 21, Parts 800 to 898. In
device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In device can be found in the Code of Federal Regulations, wour device in the Federal Register.

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Page 2- Mr. Kay

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a substantial offer requirements
mean that FDA has made a determination that your device Federal agencies mean that FDA has made a delemination maily of a winistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registration of the Act or any Federal statues and regulations and limited to: registration
You must comply with all the Act's requirements, including, but not regarting You must comply whil an the Act 3 requirements, and 801); medical device reporting and listing (21 CFR Part 807), laocing (21 CFR 803); good manufacturing
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of medical device-telated adverse evenis) (2) eggulation (21 CFR Part 820);
practice requirements as set forth in the quality systems (QS) regulation (21 af 2 practice requirements as set form in the quality of seems ( ( + ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 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

please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm113809.html for http://www.rda.gov/About/DA/CentersOfHotel's (CDRH's) Office of Compliance. Also, the Center for Devices and Radiological results of teference to premarket notification" please note the regulation ennitied, "Whoolding of receing of adverse events under the MDR regulation (21 CFR Part 803), please go to

MDR regulation (21 CFN Far 609), prease go w
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's http://www.ida.gov/Medical/Dovetrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may oblain offer general information on Jour Assistance at its toll-free Division of Sman Manufacturers of 301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Bunney

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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Indications for Use

510(k) Number (if known): Қ | Օ\ Կ (65

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

Indications for Use:

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

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

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 Exaluation (ODE)

Susan Runnt

(Division Sign-Off)
Division of Anesthesiology, General Hospitable 1 of 1
Division of Anesthesiology, General Devices Division of Anesthous Devices

Number: K10146

11 of 176

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.)