Who is the manufacturer of Straumann Variobase C?

Institut Straumann AG filed the 510(k) submission for Straumann Variobase C (K192742).

What is the FDA product code for Straumann Variobase C?

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 Variobase C?

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

Who can help prepare an FDA 510(k) submission like Straumann Variobase C?

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 Variobase C

K192742 · Institut Straumann AG · NHA · Feb 12, 2021 · Dental

Device Facts

Record ID	K192742
Device Name	Straumann Variobase C
Applicant	Institut Straumann AG
Product Code	NHA · Dental
Decision Date	Feb 12, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Straumann® Variobase C abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns.

Device Story

Two-piece dental abutment system consisting of titanium-aluminum-niobium (TAN) alloy base (Ti-base), basal screw, and patient-specific prosthetic coping/crown. Used in dental clinics by clinicians to restore function/aesthetics for patients with Straumann dental implants. Clinician uses Sirona CEREC CAD/CAM software to design custom restorations; milling units fabricate the coping/crown. The Ti-base interfaces with the implant; the custom restoration is bonded to the Ti-base. System supports various Straumann implant platforms (NC, RC, NNC, RB/WB, WB). Provides stable support for prosthetic reconstructions, benefiting patients by enabling customized, digitally-designed tooth replacement.

Clinical Evidence

Bench testing only. Dynamic fatigue and static strength testing conducted per FDA guidance for endosseous dental abutments and ISO 14801:2016. Sterilization validation performed per ISO 17665-1/2 and FDA reprocessing guidance. No clinical data provided.

Technological Characteristics

Two-piece abutment system. Base material: Titanium-aluminum-niobium (TAN) alloy. Compatible with Sirona CAD/CAM digital workflow. Provided non-sterile; terminally sterilized via autoclave. Dimensions vary by implant platform (NC, RC, NNC, RB/WB, WB).

Indications for Use

Indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations using titanium alloy abutments placed onto Straumann dental implants. Requires use of Sirona CEREC Software for design and Sirona CEREC, inLab MC X, or MC XL milling units for manufacturing.

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

Variobase for CEREC (K151324)

Reference Devices

Sirona Dental CAD/CAM System (K181520)
Straumann n!ce Glas Ceramic A14 Blocks (K171773)
Straumann BLX Implant System (K173961)
Straumann Variobase (K142890)
MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)

Related Devices

K220878 — Straumann TLX Variobase C · Institut Straumann AG · Jun 16, 2022
K173945 — Straumann SC Variobase Abutments · Institut Straumann AG · Oct 5, 2018
K150296 — Biodenta Customized Abutment-Hybrid · Biodenta Swiss AG · Jul 2, 2015
K190082 — Straumann BLX Variobase Abutment · Institut Straumann AG · Apr 17, 2019
K151324 — Straumann Variobase for CEREC · Straumann USA, LLC · Sep 11, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Institut Straumann AG % Jennifer Jackson Directory, Regulatory Affairs Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01801 Re: K192742 Trade/Device Name: Straumann® Variobase® C Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: January 14, 2021 Received: January 15, 2021 ### 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. {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 (QS) 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, Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 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) K192742 Device Name: Straumann® Variobase® C Indications for Use (Describe) The Straumann® Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. 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 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® Variobase® C 510(k) Summary #### 1 510(k) Summary #### Submitter's Contact Information 1.1 | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | | On behalf of: | | | Institut Straumann AG Peter Merian Weg, 12 CH-4002 Basel, Switzerland | | Contact Person: | Jennifer M. Jackson, MS Director of Regulatory Affairs and Quality Phone Number: +1-978-747-2509 Fax Number: +1-978-747-0023 | | Prepared By & Alternate Contact: | Gordon Dodds Manager Design Control QM Etkon GmbH Phone number: +49 89 30 90 75 291 | | Date of Submission: | February 12, 2021 | #### 1.2 Name of the Device | Trade Names: | Straumann® Variobase® C | |------------------------|------------------------------------| | Common Name: | Endosseous dental implant abutment | | Classification Name: | Endosseous dental implant abutment | | Regulation Number: | §872.3630 | | Device Classification: | II | | Product Code(s): | NHA, PNP | | Classification Panel: | Dental | {4}------------------------------------------------ ## Straumann® Variobase® C 510(k) Summary #### Predicate Device(s) 1.3 Primary Predicate: - K151324 Variobase for CEREC (Institut Straumann AG) . Reference Devices: - K181520 Sirona Dental CAD/CAM System (Sirona Dental) . - K171773 Straumann n!ce Glas Ceramic A14 Blocks (Institut Straumann AG) . - . K173961 – Straumann BLX Implant System (Institut Straumann AG) - K142890 Straumann Variobase (Institut Straumann AG) . - K190662 MRI Compatibility for Existing Straumann Dental Implant Systems (Institut . Straumann AG) ### 1.4 Device Description The Straumann® Variobase® C abutments are two-piece abutments composed of the following components: - . Straumann® Variobase® C (Ti-base) - . Prosthetic Restoration (patient specific coping or crown) - . Basal Screw The Straumann® Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platforms: RC (Regular CrossFit®), NC (Narrow CrossFit®), NNC (Narrow Neck CrossFit®), RB/WB(Regular Base/Wide Base), and WB (Wide Base). The Straumann® Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half materials that are compatible with the Straumann Variobase C abutments include IPS e.max CAD, inCoris ZI, and n!ce. The top half material compatibility is dependent on the dental implant platform, with inCoris Zl and n!ce only being compatible with the RC (Regular CrossFit®) and NC (Narrow CrossFit®) platforms. {5}------------------------------------------------ ## Straumann® Variobase® C 510(k) Summary #### 1.5 Intended Use Straumann® Variobase C abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns. #### 1.6 Indications for Use The Straumann® Variobase®C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® C abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. #### 1.7 Comparison of Technological Characteristics and Indications for Use The subject and primary predicate Indications for Use differ only in the removal of the software version and the change in trade name. The software version validated as part of this submission is captured in Table 1 below, and the removal of this information from the Indications for Use statement does not change the intended use of the subject device system. As outlined in Table 1, the subject system includes a combination of previously-cleared technologies that are now being implemented into one system. The Variobase technology has received prior clearance for each implant body compatibility. The ceramic materials have received prior clearance for use as the second piece of a two-piece abutment under product code NHA and for use with the Sirona CAD/CAM digital workflow. Performance testing has addressed any differences resultant from these new combinations of technologies. The technological characteristics of the subject devices are compared to the primary predicate device in Table 1. The reference device K190662 is included for reference to MRI compatibility. {6}------------------------------------------------ # Straumann® Variobase® C 510(k) Summary | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| K Number | K192742 | K151324 | K181520 | K142890 | K171773 | K173961 | | Indications for Use | The Straumann® Variobase® Care titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Cabutments are indicated for screw- retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. | The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw- retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple- unit cement retained restorations. For the BH 3.0 S, SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructured. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: | The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. | The Straumann® nice Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti- base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply: Straumann RC Variobase for CEREC - 022.0024 - Block Size L Straumann NC Variobase for CEREC - 022.0025 - Block Size L Straumann RN Variobase for CEREC - 022.0019 - Block Size L Straumann WN Variobase for CEREC - 022.0020 - Block Size L | Straumann® BLX Implants Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components. Straumann® BLX Closure Caps and Healing Abutments Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months. Straumann® BLX Basal Screws and Temporary Abutments Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days. Straumann® BLX Variobases The Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. | | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | | K Number | K192742 | K151324 | K181520 | K142890 | K171773 | K173961 | | Compatible Implants | Straumann Bone Level implantshaving the NC and RC implant-to- abutment interface geometries. Straumann Tissue Level implantshavingthe NNC implant-to-abutment interface geometries. Straumann BLX implants having the RB/WB and WB implant-to-abutment interface geometries. | Straumann Bone Level implantshaving the NC and RC implant-to- abutment interface geometries. Straumann Tissue Level implantshaving the RN and WN implant-to- abutment interface geometries. | Nobel Biocare - Replace, Active, and Branemark Straumann - Sy nocta and Bone Lev el Dentsply Sirona Implants – Osseospeed, Xive, Osseospeed EV, and Anky los Biomet 3i – Osseotite and Certain Zimmer – Tapered Screw- Vent Thommen Medical - SPI Element, SPI Element Inicell, SPI Contact Inicell Osstem/Hiossen – Osstem TS Implant System and Hiossen Implant System Biohorizons (Internal Connection | Straumann Bone Level implantshaving the NC and RC implant-to- abutment interface geometries. Straumann Tissue Level implantshavingthe NNC, RN, and WN implant-to-abutment interface geometries. | Straumann Bone Level implants having the NC and RC implant-to- abutment interface geometries. Straumann Tissue Level implants having the RN and WN implant-to- abutment interface geometries. | Straumann BLX implantshaving the RB/WB and WB implant-to-abutment interface geometries. | | Compatible Restoration Materials | Sirona inCorisZi meso (S and L) – K181520 Ivoclar IPS e.max CAD (S and L) – K151324 Straumann n!ce Glass Ceramic A14 Blocks (L) – K171773 | Sirona inCorisZi (L) – K062509 and K123664 Ivoclar IPS e.max CAD (S and L) – K132209 Ivoclar TelioCAD (S and L) – K093708 | Sirona inCorisZi (S and L) | Traditional Workflow: Type 4 Metals (ISO 22674) IPS e.max® Press Ceramic Digital Workflow: polycon® ae (temporary) zerion® (permanent) IPS e.max® CAD Ceramic (permanent) coron® (permanent) | Straumann n!ce Glass Ceramic A14 Blocks (L) | Digital Workflow: polycon® ae (temporary) IPS e.max® CAD Ceramic (permanent) | | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | | K Number | K192742 | K151324 | K181520 | K142890 | K171773 | K173961 | | Coronal Diameters | NC: 2.98 mm (Size S or L) RC: 3.38 mm (Size L) NNC: 2.98 mm (Size S) RB/WB: 2.98 mm (Size S) and 3.38 mm (Size L) WB: 3.38 mm (Size L) | NC: 3.38 mm (Size L) RC: 3.38 mm (Size L) RN: 3.38 mm (Size L) WN: 3.38 mm (Size L) | NC: 3.38 mm (Size L) RC: 3.38 mm (Size L) | NC: 2.80 mm RC: 2.90 mm NNC: 2.80 mm | N/A | RB/WB: 2.80 mm (3.8 mm diameter platform) 2.90 mm (4.5 mm diameter platform) WB: 2.90 mm…