Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.

Device Description

The Straumann prosthetic line consist of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

The Straumann BLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by mean of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). The screw channel is protected during the lab procedure with a modeling aid made of Polyoxymethylene (POM) which is friction fit to the Ceramicor® alloy base. The modeling aid is a burn-out sleeve for casting and the combination of base and modeling aid is designed to be used together with Straumann BLX Implants having the TorcFit™, conical connection.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Straumann® BLX Gold Abutments) and does not describe an AI medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details for AI performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for an AI system.

The document focuses on demonstrating substantial equivalence to predicate devices through material comparison, biocompatibility, sterilization validation, and bench testing for mechanical properties (dynamic fatigue, static strength, and loosening torque).

Here's an overview of the "acceptance criteria" and "study" information that is present, pertaining to a traditional medical device, not an AI one:

Acceptance Criteria and Reported Device Performance (as relevant for a traditional medical device)

Acceptance Criteria Category	Reported Device Performance (or demonstration method)
Biocompatibility	Assessed according to ISO 10993-1:2009 and FDA Guidance. Stated to be equivalent to primary predicate (K070549) due to same material, nature of body contact, contact duration, material formulation, and sterilization methods. No new testing performed.
Sterilization	Recommended end-user sterilization (Moist Heat Steam) validated according to ISO 17665-1, ISO 17665-2, and FDA guidance "Reprocessing Medical Devices in Health Care Settings". Provided non-sterile.
Bench Testing (Dynamic Fatigue, Static Strength, Loosening Torque)	Conducted according to FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Testing performed on a worst-case construct. Results demonstrated equivalence to predicate devices.

Missing Information (as it pertains to an AI medical device, which this is not):

Sample sizes for test set and data provenance: No test set as described for an AI model.
Number of experts and qualifications to establish ground truth: Not applicable for this type of device.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Stand-alone (algorithm only) performance study: Not applicable.
Type of ground truth used: Not applicable.
Sample size for training set: Not applicable.
How ground truth for training set was established: Not applicable.

Summary

{0}------------------------------------------------

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, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

August 19, 2020

Straumann USA, LLC (On behalf of Institut Straumann AG) Chanrasmey White Regulatory Affairs Specialist 60 Minuteman Road Andover, Massachusetts 01810

Re: K200597

Trade/Device Name: Straumann® BLX Gold 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 20, 2020

Dear Chanrasmey White:

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K200597

Device Name Straumann® BLX Gold Abutments

Indications for Use (Describe)

Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Straumann® BLX Gold Abutments

510(k) Summary

510(k) Summary 5

Submitter 5.1

Straumann USA, LLC (on behalf of Institut Straumann AG)

60 Minuteman Road

Andover, MA 01810

Phone Number:	978-747-2614
---------------	--------------

Fax Number: 978-747-0023

Chanrasmey White Contact Person:

Date of Submission: August 18, 2020

5.2 Device

Trade Name:	Straumann® BLX Gold Abutments
Common Name:	Endosseous Dental Implant Abutments
Classification Name:	Endosseous Dental Implant Abutments
Regulatory Class:	II (21 CFR 872.3630)
Product Code:	NHA (21 CFR 872.3630)

5.3 Predicate Device

Primary Predicate:

K070549 - RC Gold Abutments

Reference Predicate:

K072497 - NC Gold Abutment, crowns

K071888 – Gold Abutment for Bridge

K190662 – MRI Compatibility for Existing Straumann Dental Implant System

K173961 - BLX Implant System

{4}------------------------------------------------

Straumann® BLX Gold Abutments

510(k) Summary

5.4 Device Description

5.5 Indications for Use

Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.

Technoloqical Characteristics 5.6

The subject device is equivalent to the primary predicate cleared per K070549 and reference devices cleared per K072497 and K071888 with the exception of the implant to abutment connection which is TorcFit™ to fit the implants of the BLX Implant System cleared per K173961. The reference device K190662 is included to address MRI compatibility only.

The technological characteristics of the proposed BLX Gold Abutments are compared to the primary predicate in Table 1.

{5}------------------------------------------------

Straumann® BLX Gold Abutments

510(k) Summary

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATEDEVICE	REFERENCE PREDICATEDEVICE	REFERENCE PREDICATEDEVICE
K Number	K200597	K070549	K072497	K071888
Indications forUse	Straumann abutments areintended to be placed intoStraumann dental implants toprovide support for prostheticreconstructions such as crowns,bridges, and overdentures.	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such ascrowns, bridges andoverdentures.	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such ascrowns, bridges andoverdentures.	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such ascrowns, bridges andoverdentures.
Material	Ceramicor®	Ceramicor®	Ceramicor®	Ceramicor®
AbutmentShape inCoronalPortion	Axial screw access hole forplacement of abutment intoimplant	Axial screw access hole forplacement of abutment intoimplant	Axial screw access hole forplacement of abutment intoimplant	Axial screw access hole forplacement of abutment intoimplant
Design ofBasal Portionof Abutment	TorcFit™ Connection for BLXImplants(conical connection)	CrossFit® Connection forBL/BLT Implants(conical connection)	CrossFit® Connection forBL/BLT Implants(conical connection)	CrossFit® Connection forBL/BLT Implants(conical connection)
Restoration	Crown and Bridge	Crown	Crown	Bridge
Diameter	3.8 mm, 4.5 mm, and 5.5 mm	4.5 mm	3.8 mm	4.7 mm
GingivaHeight	1.5 mm	3.7, 3.8, 5.2 mm	3.7 mm	5.2 mm
TotalAbutmentHeight	4.5 mm, 6.8 mm	8.2 mm	6.5 mm	6.2 mm
ProsthesisType	Cemented or screw retained	Cemented or screw-retained	Cemented or screw-retained	Cemented or screw-retained
Base Screw	Ti-6Al-7NbBasal Screw	Ti-6Al-7NbBasal Screw	Ti-6Al-7NbBasal Screw	Ti-6Al-7NbBasal Screw
MaximumAngulation	30°	30°	30°	30°

Table 1 – Comparison Matrix

{6}------------------------------------------------

Straumann® BLX Gold Abutments

510(k) Summary

5.7 Performance Data

The following performance data is provided in support of the substantial equivalence determination.

Biocompatibility Testing

The subject devices have been assessed for biological safety 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 the subject device.

The subject device is made out of the same material as the primary predicate device, therefore, biocompatibility is represented by the primary predicate. The subject devices are equivalent with regard to nature of body contact, contact duration, material formulation and sterilization methods compared to the primary and reference predicate devices and therefore, no new testing has been performed.

Sterilization

The proposed BLX Gold Abutments are single patient devices and are provided nonsterile. The recommended end user sterilization via Moist Heat Steam sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".

Bench Testing

Dynamic fatigue, static strength, and loosening torque tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Testing was performed on worst-case construct. The worst-case construct is based on several device features such as diameter, wall thickness and orientation and intends to represent the performance behavior of all the devices within

{7}------------------------------------------------

Straumann® BLX Gold Abutments

510(k) Summary

this submission. The worst-case construct was tested and results demonstrated equivalence to the predicate devices.

5.8 Conclusion

The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the predicate 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.)