Who is the manufacturer of Straumann BLX Gold Abutments?

Straumann USA, LLC (On Behalf of Institut Straumann Ag) filed the 510(k) submission for Straumann BLX Gold Abutments (K200597).

What is the FDA product code for Straumann BLX Gold Abutments?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Straumann BLX Gold Abutments?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Straumann BLX Gold Abutments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Straumann BLX Gold Abutments

K200597 · Straumann USA, LLC (On Behalf of Institut Straumann Ag) · NHA · Aug 19, 2020 · Dental

Device Facts

Record ID	K200597
Device Name	Straumann BLX Gold Abutments
Applicant	Straumann USA, LLC (On Behalf of Institut Straumann Ag)
Product Code	NHA · Dental
Decision Date	Aug 19, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended Use

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

Device Story

Straumann BLX Gold Abutments are dental prosthetic components used to support crowns, bridges, and overdentures. The device consists of a Ceramicor alloy base secured to a Straumann BLX dental implant via a Ti-6Al-7Nb (TAN) basal screw. A Polyoxymethylene (POM) burn-out modeling aid is friction-fitted to the base for laboratory casting procedures. The system utilizes the TorcFit conical connection. Used in dental clinics by clinicians, the abutment serves as the interface between the endosseous implant and the final prosthetic restoration. The clinician selects the appropriate size and shape to meet individual patient anatomical needs. The device is provided non-sterile and requires steam sterilization by the end-user prior to placement. By providing a stable connection to the implant, the abutment enables the functional and aesthetic restoration of missing teeth.

Clinical Evidence

Bench testing only. No clinical data was provided. Performance was validated through dynamic fatigue, static strength, and loosening torque testing conducted per FDA guidance for Class II Special Controls for Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Biocompatibility was established via material equivalence to the primary predicate.

Technological Characteristics

Materials: Ceramicor alloy base, Ti-6Al-7Nb (TAN) basal screw, Polyoxymethylene (POM) modeling aid. Connection: TorcFit conical connection. Dimensions: 3.8mm, 4.5mm, 5.5mm diameters; 1.5mm gingiva height; 4.5mm/6.8mm total heights. Sterilization: Non-sterile, validated for moist heat steam sterilization (ISO 17665-1/2).

Indications for Use

Indicated for patients requiring dental implant-supported prosthetic reconstructions, including crowns, bridges, and overdentures.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

RC Gold Abutments (K070549)

Reference Devices

NC Gold Abutment, crowns (K072497)
Gold Abutment for Bridge (K071888)
MRI Compatibility for Existing Straumann Dental Implant System (K190662)
BLX Implant System (K173961)

Related Devices

K151590 — Straumann RN Gold Abutment for Bridge · Straumann USA, LLC · Mar 4, 2016
K231874 — AOT & T-L Abutment · Truabutment, Inc. · Oct 30, 2023
K203355 — Straumann TLX Novaloc and Cementable Abutments · Institut Straumann AG · Feb 12, 2021
K213063 — TLX SRAs and TLX Gold Abutments · Institut Straumann AG · Apr 8, 2022
K082764 — STRAUMANN WN CARES TITANIUM ABUTMENT · Institut Straumann AG · Oct 1, 2008

Submission Summary (Full Text)

{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) | |-------------------------------------------------| |-------------------------------------------------| | <input checked="" type="checkbox"/> | Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------|----------------------------------------------| | <input type="checkbox"/> | 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 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. ## 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 PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | REFERENCE PREDICATE DEVICE | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K200597 | K070549 | K072497 | K071888 | | 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. | Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. | Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. | Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. | | Material | Ceramicor® | Ceramicor® | Ceramicor® | Ceramicor® | | Abutment Shape in Coronal Portion | Axial screw access hole for placement of abutment into implant | Axial screw access hole for placement of abutment into implant | Axial screw access hole for placement of abutment into implant | Axial screw access hole for placement of abutment into implant | | Design of Basal Portion of Abutment | TorcFit™ Connection for BLX Implants (conical connection) | CrossFit® Connection for BL/BLT Implants (conical connection) | CrossFit® Connection for BL/BLT Implants (conical connection) | CrossFit® Connection for BL/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 | | Gingiva Height | 1.5 mm | 3.7, 3.8, 5.2 mm | 3.7 mm | 5.2 mm | | Total Abutment Height | 4.5 mm, 6.8 mm | 8.2 mm | 6.5 mm | 6.2 mm | | Prosthesis Type | Cemented or screw retained | Cemented or screw-retained | Cemented or screw-retained | Cemented or screw-retained | | Base Screw | Ti-6Al-7Nb Basal Screw | Ti-6Al-7Nb Basal Screw | Ti-6Al-7Nb Basal Screw | Ti-6Al-7Nb Basal Screw | | Maximum Angulation | 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.