The subject Novaloc TiN Abutments are intended to be placed onto Straumann dental implants to provide support for full or partial arch detachable restorations (over-denture). The coronal portion of the subject abutments are similar to the primary predicate devices, whereas the apical portion of the abutments has the appropriate implant-to-abutment interface geometry for each of the platforms of the Straumann Dental Implant System. The Novaloc abutments are manufactured from TAV (Ti-6AI-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject Novaloc TiN Abutments are provided in straight and anqulated models, in different heights. The subject Novaloc TiN Abutment is also provided in a bar attachment. The Novaloc TiN abutments are provided non-sterile with instructions for end user sterilization.

AI/ML Overview

The provided text describes a 510(k) premarket notification for dental implant abutments, focusing on the substantial equivalence of the new device to existing predicate devices. However, it does not contain information about a study that proves a device meets specific acceptance criteria related to a machine learning or AI-driven medical device, nor does it include details about ground truth establishment, expert adjudication, or MRMC studies, which are characteristic of AI/ML device evaluations.

The document is purely a regulatory submission for a physical medical device (dental abutments) and focuses on engineering and biocompatibility testing for substantial equivalence, not performance criteria for diagnostic or algorithmic accuracy.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document refers to "Performance Testing" for the dental abutments, but this is in the context of mechanical, sterilization, and biocompatibility testing, not AI/ML performance.

To answer your request, I would need a document describing the evaluation of an AI/ML medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 13, 2020

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K193046

Trade/Device Name: Straumann® Retentive System - Novaloc TiN Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 16, 2020 Received: July 17, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K193046

Device Name:

Straumann® Retentive System - Novaloc TiN Abutments

Indications for Use (Describe)

The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED

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FORM FDA 3881 (7/17)

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K193046 – Traditional 510(k)

Straumann Retentive System – Novaloc TiN Abutments

510(k) Summary

510(k) Summary 5

5.1 Submitter's Contact Information

Submitter:	Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Institut Straumann AGPeter Merian-Weg 124052 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By &Alternate Contact:	Ana Carolina Martins ViannaRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone Number: +41 61 965 1259
Date of Submission:	August 11, 2020

5.2 Name of the Device

Trade Names:	Straumann® Retentive System – Novaloc TiN Abutments
Common Name:	Endosseous Dental Implant Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Classification:	Class II
Product Code(s):	NHA
Classification Panel:	Dental Devices

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K193046 - Traditional 510(k)

Straumann Retentive System - Novaloc TiN Abutments

510(k) Summary

5.3 Predicate Device(s)

Primary Predicate:

K190040 Straumann BLX Line Extension New Abutments .
Reference Devices:
K033699 Locator Bar Female .
K151157 – Straumann Variobase Abutments For Bridges/Bars
. K171649 – Straumann CARES M-Series CAD/CAM System
K190662 MRI Compatibility for Existing Straumann Dental Implant Systems .

Device Description 5.4

Intended Use 5.5

Prosthetic components connected to the implant or abutment, are intended for use as an aid in prosthetic rehabilitation.

Indications for Use 5.6

The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs.

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K193046 – Traditional 510(k)

Straumann Retentive System – Novaloc TiN Abutments

510(k) Summary

Technological Characteristics 5.7 -

The primary predicate devices and subject devices have many of the same technological characteristics. The abutment material, surface coating, angulation and snap-on feature are identical to the primary predicate device. The main technological difference is the implant-toabutment connections. Nevertheless, all subject connections are well established and compatible with FDA cleared Straumann implant connections (NC, RC, RN, and WN). A complete comparison of the primary and reference predicate devices with the subject abutments is provided in Table 1.

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE	REFERENCEDEVICES
K Number	K193046	K190040	K171649	K151157
Indicationsfor Use	The StraumannRetentive System isindicated for theattachment of full orpartial dentures onStraumann dentalimplants and barconstructs.	Straumann BLX NovalocAbutments:The StraumannRetentive System isindicated for theattachment of full orpartial dentures onStraumann dentalimplants.(Indications for Use relatedto other types of abutmentsare not considered in thistable)	The Straumann CARESM-Series CAD/CAMSystem is indicated forthe design and fabricationof single or multiple- unitimplant-borne prostheticsfor the restoration ofpartially or fullyedentulous mandiblesand maxillae. The systemintegrates multiplecomponents of the digitaldentistry workflow: scanfiles from Intra-OralScanners or Extra-OralScanners, CAD software,CAM software, restorationmaterial blanks, millingmachines and associatedtooling and accessories.The system is used todesign and fabricateCAD/CAM milled coping,crown and bridgerestorations to becemented ontoStraumann® Variobase®Abutments, as well asmilled abutments to beaffixed to the endosseousdental implants of theStraumann® DentalImplant System using abasal screw.	Straumann Variobaseprosthetic componentsdirectly connected tothe endosseous dentalimplants are indicatedfor use as an aid inprostheticrehabilitations. Theprosthetic restoration(bridge or overdenture)can be cemented onthe Straumann®Variobase prostheticcomponents. Atemporary restorationcan be used prior tothe insertion of thefinal components tomaintain, stabilize andform the soft tissueduring the healingphase. They may notbe placed intoocclusion. Finalabutments andrestorations may beplaced into occlusionwhen the implant isfully osseointegrated.
Material	TAV(Ti-6Al-4V)	TAV(Ti-6Al-4V)	Ti-6Al-7Nb	Ti-6Al-7Nb
SurfaceTreatment	TiN coating	TiN coating	No coating	No coating

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K193046 – Traditional 510(k)

Straumann Retentive System - Novaloc TiN Abutments

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE	REFERENCEDEVICES
K Number	K193046	K190040	K171649	K151157
Implant toAbutmentConnection	Straumann NCconnectionStraumann RCconnectionStraumann RNconnectionStraumann WNconnection	Straumann BLXconnection	Straumann NCconnectionStraumann RCconnectionStraumann NNCconnectionStraumann RNconnectionStraumann WNconnection	Straumann NCconnectionStraumann RCconnectionStraumann NNCconnectionStraumann RNconnectionStraumann WNconnection
AbutmentHeight	1, 2, 3, 4, 5, and 6mm	up to 6.5 mm	n/a	3.5 - 5.2 mm
Angulation	0 and 15°	0 and 15°	30° of copingangulation	30° of copingangulation
SterilizationMethod	Moist heat end usersterilization	Moist heat end usersterilization	Moist heat end usersterilization	Moist heat end usersterilization

510(k) Summary

Table 1 – Comparison of subject Novaloc TiN Abutments versus primary predicate and reference device

The primary predicate (K190040) is included for reference to the Straumann BLX Novaloc Abutments. The indications for use for the primary predicate contains reference to many different types of abutments. The intended use and indications for use of the subject device are identical to the Straumann BLX Novaloc Abutments.

The reference device K190662 is included for the MRI compatibility.

The subject Novaloc Abutments for bar attachments are equivalent to the reference device K033699 as described in Table 2.

FEATURE	PROPOSED DEVICE	REFERENCE DEVICE
K Number	K193046	K033699
Indications for Use	The Straumann® Retentive System isindicated for the attachment of full or partialdentures on Straumann dental implantsand bar constructs.	The Locator Bar Attachment System isdesigned for use with overdentures orpartial dentures retained in whole or inpart by bar splinted endosseousimplants in the mandible or maxilla
Connection	Bar	Bar
Abutment torestoration connection	Snap on feature	Snap on Feature
Type of restoration	Multiunit	Multiunit
Compatible MatrixSystem	Zest LOCATORValoc Novaloc	Zest LOCATOR
Angulation	0°	0°

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K193046 - Traditional 510(k)

Straumann Retentive System - Novaloc TiN Abutments

Material	Titanium grade 5 alloy(Ti-6Al-7V or TAV)	Titanium,Stainless Steel
Abutment Coating	TiN	TiN
Construction	One Piece	One Piece
Sterility	Non-sterileEnd user sterilization	Non-sterileEnd user sterilization

510(k) Summary

Table 2 – Comparison of subject Novaloc Abutments for bar attachments versus reference device

Performance Testing 5.8

The following performance data support the substantial equivalence determination.

5.8.1 Sterilization Validation

The subject Novaloc TiN Abutments are provided non-sterile and need to be sterilized by moist heat (steam) by the end-user. The recommended sterilization method has been validated according to ISO 17665-1 and ISO 17665-2 applicable recommendations in the FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".

5.8.2 Biocompatibility Testing

Biological assessment has been performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff", Document issued on: June 16, 2016" for each of the subject devices.

The subject devices have the same nature of body contact, contact duration, material formulation and sterilization methods compared to the primary predicate devices.

5.8.3 Bench Testing

Dynamic fatigue and static strength tests conducted according to the FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801, Dentistry - Implants - Dynamic fatigue test for endosseous dental implants, demonstrated that the Straumann Novaloc TiN Abutments are equivalent to the predicate and reference devices.

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K193046 -- Traditional 510(k)

Straumann Retentive System – Novaloc TiN Abutments

510(k) Summary

5.8.4 Clinical data

No device specific clinical data has been submitted to demonstrate substantial equivalence.

5.9 Conclusion

The documentation submitted in this premarket notification demonstrates the subject Straumann Novaloc TiN Abutments are substantially equivalent to the primary predicate and reference devices.

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.)