Straumann RN Gold Abutment for Bridge by STRAUMANN USA, LLC

The subject devices represent a line extension of the Straumann Dental Implant System (SDIS). The subject devices are an assembly of a noble metal alloy (Ceramicor®) Abutment Base and a polymer (POM) Modeling Aid. The Modeling Aid is attached to the abutment base by means of a friction fit. The subject devices employ the same Modeling Aid (catalog no. 049.217) as the identified predicate devices. The subject devices use the same Basal Screw for fixing the finished restoration to the implant (catalog no. 049.128) as the identified predicate devices. The subject devices interface with Straumann Tissue Level (TL) implants having the Regular Neck (RN) or Wide Neck (WN) implant-to-abutment interface. The subject devices do not engage the anti-rotation features within the TL implants. The non-engaging design makes these devices suitable for the fabrication of bar and bridge superstructures by the dental laboratory using either casting or soldering techniques.

AI/ML Overview

This document is a 510(k) Premarket Notification for a dental abutment, specifically the "Straumann® synOcta Gold Abutments for Bridge." The purpose of this notification is to demonstrate that the new device is substantially equivalent to existing predicate devices already on the market, rather than proving a new medical claim or performance characteristic that would require extensive clinical trials. Therefore, the information provided focuses on the device's design, material, and mechanical performance compared to a predicate, not on complex acceptance criteria for a diagnostic algorithm or a clinical outcome.

Here's an analysis of the provided text in the context of the requested information, understanding that this is for a physical medical device (dental abutment) and not an AI/diagnostic tool:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" in the way one would for a diagnostic device (e.g., sensitivity, specificity, accuracy thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device through conformity to existing standards and showing comparable mechanical performance.

Acceptance Criterion (from Guidance/Standard)	Reported Device Performance (Subject Device)
Conformity with FDA Guidance: Root-form Endosseous Dental Implants and Endosseous Dental Abutments (May 12, 2004)	Substantial equivalence satisfactorily addressed.
Conformity with ISO 14801 (Dynamic Fatigue Test for dental implants)	Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced.
Material Properties (Type 5 material per ISO 22674)	Ceramicor alloy has 0.2% Proof Strength of 780 N/mm² (as delivered) and 635 N/mm² (after processing), satisfying Type 5 material requirements of ISO 22674.
Biocompatibility	Not required; materials are the same as the identified predicate device.
Sterilization	Not required; methods of manufacture are the same as the identified predicate device.
Indications For Use	Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. (Compared to predicate: "Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges.") The document states this difference does not materially change the intended uses.
Shared Features with Predicate	Same implant-to-abutment connection (RN, WN), platform (RN, WN), materials (Ceramicor, POM, Ti-6Al-7Nb alloy), primary package, and sterilization method (non-sterile, terminal sterilization via moist heat).
Designed for multi-unit (bridge) restorations	Non-engaging design, suitable for multi-unit (bridge) restorations.

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 mentions "Dynamic fatigue test data" in support of the submission. However, it does not specify:

The sample size for these tests.
The specific data provenance (country of origin, retrospective or prospective).
Details about a "test set" in the context of diagnostic performance. The testing here is mechanical (fatigue).

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 question is not applicable to this submission. The device is a physical dental abutment, and its "performance" is evaluated through mechanical bench testing and material characterization, not by expert interpretation or ground truth establishment in a clinical imaging or diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. There is no "adjudication" in the sense of reconciling expert opinions for a diagnostic outcome. Mechanical tests are typically performed according to standardized protocols.

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 question is not applicable. MRMC studies are used for diagnostic devices involving human readers and AI. This submission is for a physical dental abutment.

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

This question is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, "ground truth" is established through:

Mechanical standards: Adherence to international standards like ISO 14801 for dynamic fatigue testing.
Material specifications: Conforming to material standards like ISO 22674 for metallic dental materials.
Biocompatibility and Sterilization: Relying on the established safety of the materials and manufacturing methods used in the predicate devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are developed through engineering and materials science, not by training an algorithm on data.

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

This question is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

March 4, 2016

Straumann USA, LLC Mr. Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, Massachusetts 01810

Re: K151590

Trade/Device Name: Straumann® synOcta Gold Abutments for Bridge Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 2, 2016 Received: February 3, 2016

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 (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 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 -S

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) K151590

Device Name

Straumann® synOcta Gold Abutments for Bridge

Indications for Use (Describe)

Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.

Type of Use (Select one or both, as applicable)

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	K151590
	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(978) 747-2575
	Date Prepared:	February 23, 2016
	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)
	Common Name:	Endosseous dental implant abutment
	Proprietary Name:	Straumann® synOcta Gold Abutments for Bridge
	Primary Predicate Device:	K041295, RN synOcta UCLA Gold Abutment (Straumann)
	Reference Device(s)	K063789, WN synOcta UCLA Gold Abutment (Straumann)K133421, Magellan Screw Retained Abutments (Straumann)K141871, Straumann Screw-Retained Abutments (Straumann)K150814, Straumann Screw-Retained Abutments (Straumann)
	Device Description:	The subject devices represent a line extension of the StraumannDental Implant System (SDIS). The subject devices are anassembly of a noble metal alloy (Ceramicor®) Abutment Baseand a polymer (POM) Modeling Aid. The Modeling Aid isattached to the abutment base by means of a friction fit. Thesubject devices employ the same Modeling Aid (catalog no.049.217) as the identified predicate devices. The subjectdevices use the same Basal Screw for fixing the finishedrestoration to the implant (catalog no. 049.128) as the identifiedpredicate devices.The subject devices interface with Straumann Tissue Level( TL ) implants having the Regular Neck ( RN ) or Wide Neck
	(WN) implant-to-abutment interface. The subject devices donot engage the anti-rotation features within the TL implants.The non-engaging design makes these devices suitable for thefabrication of bar and bridge superstructures by the dentallaboratory using either casting or soldering techniques.
Indications For Use:	Prosthetic components directly or indirectly connected to theendosseous dental implant are intended for use as an aid inprosthetic rehabilitations.
Materials:	The subject devices are an assembly of a noble metal alloy(Ceramicor®) Abutment Base and a polymer (POM) ModelingAid. The Modeling Aid is sacrificed during the castingprocedure and is no longer present in the final restoration.
	The Abutment Base of the subject devices consists of theCeramicor precious metal alloy provided by Cendres + Metaux(Biel-Bienne, Switzerland). Ceramicor is a non-oxidizing alloyfor casting-on with precious metal alloys or for soldering withprecious metal or non-precious metal alloys. The MeltingRange is 1400 – 1490°C (2552 – 2714°F). The 0.2% ProofStrength is 780 N/mm² as delivered and 635 N/mm² afterprocessing, which satisfies the requirements of a Type 5material per ISO 22674, Dentistry -- Metallic materials forfixed and removable restorations and appliances. The materialis self-hardening.
TechnologicalCharacteristics:	The Abutment Base component of the proposed Straumann®synOcta Gold Abutments for Bridge are manufactured usingprecision machining systems from solid material (i.e. one-piececonstruction). The Modeling Aid and Basal Screw componentsare the same components used for the identified predicatedevices. A comparison of the technological characteristics ofthe subject devices and the predicate devices is provided in thetable below.
	The Indications for Use language for the subject and primarypredicate devices have slightly different. However, thisdifference in language does not materially change the intendeduses of these devices or the determination of substantialequivalence.

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Feature	Subject DevicesStraumann® synOcta GoldAbutments for Bridge	Primary Predicate DevicesStraumann RN synOcta UCLAGold Abutment(K041295)
Indications For Use	Prosthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations.	Abutments are intended to be placedinto dental implants to providesupport for prostheticreconstructions such as crowns orbridges.
Implant-to-AbutmentConnection	Tissue Level Regular Neck (RN)Tissue Level Wide Neck (WN)	Tissue Level Regular Neck (RN)Tissue Level Wide Neck (WN)
Implant-to-AbutmentPlatform(s)	Regular Neck (RN)Wide Neck (WN)	Regular Neck (RN)Wide Neck (WN)
Abutment Angulation(s)	Straight, Angled to 30°	Straight
Engagement	Non-engaging; suitable for multi-unit (bridge) restorations	Engaging; suitable for single-unit(crown) restorations
Material(s)	Ceramicor noble metal alloyPOM polymerTi-6Al-7Nb alloy	Ceramicor noble metal alloyPOM polymerTi-6Al-7Nb alloy
Primary Package	Medical grade polyethylene blisterwith a sealing lid	Medical grade polyethylene blisterwith a sealing lid
Sterilization	Non-sterile; intended for terminalsterilization via moist heat(autoclave)	Non-sterile; intended for terminalsterilization via moist heat(autoclave)

Performance Data: Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed.

Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission.

New biocompatibility and sterilization studies were not required for the subject devices. The materials of construction and methods of manufacture are the same for the subject device as for the identified Straumann primary predicate device.

Based upon our assessment of the design and applicable Conclusions: performance data, the subject devices have been determined to be substantially equivalent to the identified primary predicate device.

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.)