NobelProcera Zirconia Implant Bridge

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. January 3, 2025 Nobel Biocare AB Bernice Jim Head of RA Development Implant systems, US/CA & PLM, Strategy & EBS Vastra Hamngatan 1 Goteborg, Vastra Gotaland SE 411 17 SWEDEN Re: K240346 Trade/Device Name: NobelProcera Zirconia Implant Bridge Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 23, 2024 Received: December 3, 2024 Dear Bernice Jim: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical- devices/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 I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K240346 Device Name NobelProcera Zirconia Implant Bridge Indications for Use (Describe) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The letter N is made up of two intersecting lines, and the words "Nobel Biocare" are written in a simple, sans-serif font. The TM symbol is present to the right of Biocare. # 1 - 510(k) Summary — K240346 #### Submitter Information 1.1 | Submitter: | Nobel Biocare AB<br>Vastra Hamngatan 1<br>Goteborg 411 17<br>Sweden | |-----------------|--------------------------------------------------------------------------------------| | Submitted By: | Nobel Biocare Services AG<br>Balz-Zimmermann-Strasse 7<br>8302 Kloten<br>Switzerland | | Contact Person: | Bernice Jim, Ph.D. | | E-Mail: | regulatory.affairs.nb@envistaco.com | | Phone: | +41 43 211 42 00 | | Prepared By: | D. Wolf and A. Magg | | Date Prepared: | 31 December 2024 | #### 1.2 Device | Proprietary name: | NobelProcera Zirconia Implant Bridge | |----------------------|--------------------------------------| | Manufacturer: | Nobel Biocare AB | | Common Name: | Dental Abutment | | Classification Name: | Endosseous Dental Implant Abutment | | Regulation Number: | 21 CFR 872.3630 | | Device Class: | II | | Product Code: | NHA | # 1.3 Predicate Device Primary Predicate Device NobelProcera Zirconia Implant Bridge (K202452) ### Reference Device Multi-unit Abutment Plus (K161416) #### Device Description 1.4 The NobelProcera Zirconia Implant Bridge (Dental Bridge) is a patient-specific, dental implant supported, screw-retained dental implant bridge which is connected to compatible {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red stylized letter "N" on the left, followed by the text "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare". Nobel Biocare root-form endosseous dental implants (Dental Implants) or Multi-unit Abutments and is intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing. The Dental Bridge is made from yttria-stabilized tetragonal zirconia. It is designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and approved dental scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing. The Dental Bridge is available for use with Nobel Biocare's Dental Implants having Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment connections. One Dental Bridge can feature connections to 2 up to 10 Dental Implants. All Dental Bridges are provided with the required Clinical and/or Prosthetic Screw: The Clinical Screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connects the Dental Bridge with a Multi-unit Abutment. Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the External Hex, Internal Tri-Channel, or Multi-unit Abutment connections. Clinical and Prosthetic Screws are placed from the occlusal side of the restoration. To facilitate access to the connection of the restoration to the implant/abutment a screw channel must be designed into the restoration. The Dental Bridge feature an Angulated Screw Channel (ASC) when connected to a Dental Implant with Internal Conical Connection and has an ASC feature to connect to Multi-unit Abutments. NobelProcera Zirconia Implant Bridges ASC's angulation can be defined by the customer in an angulation (to the implant's or Multi-unit Abutment's axis) between 0° and 25°. The ASC allows access through a screw channel which is not in line with the implant. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left, followed by the words "Nobel Biocare" in black font on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol. ### Compatible Devices and Accessories The NobelProcera Zirconia Implant Bridge is intended to be used or exempt accessories/devices from Nobel Biocare listed in Table 1. The Subject Device line Prosthetic Screw MUA Omnigrip Mini is included in the purpose of comprehensiveness. Table 1: NobelProcera Zirconia Implant Bridge Device/Accessory compatibility overview | Compatible Implant /Abutment Platform | Platform | Clinical Metal Adapter<br>(Article number)<br>Class II | Clinical Screw<br>(Article number)<br>Class II | Prosthetic Screws<br>(Article number)<br>Class II | |-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------|---------------------------------------------------| | See 510(k) number for<br>product codes. | | | | | | | | | | | | Article | | 38483 | 28816 | 301203 | | Multi-unit<br>Multi-unit Plus<br>(K905434, K050641,<br>K052885,<br>K090630,<br>K161416,<br>K161598,<br>K202344) | NP/RP/WP<br>except<br>Multi-unit<br>External Hex<br>WP<br>External Hex<br>WP | N/A | N/A | 301203<br>(Subject Device) | | | | | N/A | 301200<br>(Subject Device) | | Internal Conical Connection<br>(K062566, K071370, K083205,<br>K133731,<br>K173418,<br>K202344) | NP | 38483<br>(K160158) | 37367<br>(K132746) | N/A | | | RP | 38484<br>(K160158) | 37606<br>(K132746) | N/A | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with a small "TM" symbol in the upper right corner of the word Biocare. | Compatible Implant /Abutment Platform | | Platform | Clinical Metal Adapter<br>(Article number)<br>Class II | Clinical Screw<br>(Article number)<br>Class II<br>See 510(k) number for<br>product codes. | Prosthetic Screws<br>(Article number)<br>Class II | |---------------------------------------------------------------------------------------|----------------|----------|--------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------| | | | WP | 38525<br>(K160158) | | N/A | | Tri-Channel Connection<br>(K023113) | Image: Implant | NP | N/A | 28837<br>(K091904) | N/A | | | | RP | | 28816<br>(K091904) | N/A | | | | WP | | 28816<br>(K091904) | N/A | | | | 6.0 | | | N/A | | External Hex<br>(K970499,<br>K022562,<br>K050406,<br>K152093,<br>K160119,<br>K161598) | Image: Implant | NP | N/A | 31171<br>(K905434) | N/A | | | | RP | | 28815<br>(K091904) | N/A | | | | WP | | 28844<br>(K091904) | N/A | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a stylized red letter N on the left, followed by the words "Nobel Biocare" in black text on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare". #### 1.5 Indications for use The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function. #### Substantial Equivalence Discussion 1.6 ### Details of the Similarities Between the Subject and Predicate Device The similarities between the NobelProcera Zirconia Implant Bridge (Subject Device) and the NobelProcera Zirconia Implant Bridge (Predicate Device) as described in Table 2 are as follows. The Subject Device has the same fundamental scientific technology, performance specifications and intended use as the Predicate Device and there is no change in indications for use statement. ## Details of the Differences Between the Subject and Predicate Device There are no significant differences between the Subject and Predicate devices but there are minor differences as follows: The Subject Device has revised how the extension length is illustrated in the product Instructions for Use (IFU) to reflect the test model used for performance testing (bench testing) and the clinical situation. The revised extension length is supported by the fatigue performance testing provided in the premarket notification. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red, stylized letter "N" on the left, followed by the words "Nobel" and "Biocare" stacked on top of each other on the right. The word "Nobel" is in a larger, bolder font than "Biocare", and the "Biocare" has a trademark symbol next to it. # Table 2: NobelProcera Zirconia Implant Bridge Predicate and Subject Device Summary | | Subject Device<br>NobelProcera Zirconia Implant Bridge<br>K240346 | Predicate Device<br>NobelProcera Zirconia Implant Bridge<br>K202452 | Comparison<br>Subject / Predicate | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Same as Predicate | | | Pictorial Representation | Dental Bridge<br>(here shown with two Clinical Metal Adapters)<br><br>Prosthetic Screw | Dental Bridge<br>(here shown with two Clinical Metal Adapters)<br><br>Prosthetic Screw | Same as Predicate | | | Product Classification | Class II | Class II | Same as Predicate | | | Regulation Number / Name | 21 CFR 872.3630<br>Endosseous Dental Implant Abutment | 21 CFR 872.3630<br>Endosseous Dental Implant Abutment | Same as Predicate | | | Product Code, primary | NHA | NHA | Same as Predicate | | | Review Panel | Dental | Dental | Same as Predicate | | | Intended use | The NobelProcera® Zirconia Implant Bridges are customized dental implant bridges. The implant Bridge attaches directly to the endosseous dental implants and/or onto Nobel Biocare's Multi-unit Abutments with prosthetic screws and provides a platform for restoration. The NobelProcera® Zirconia Implant Bridges are designed and made individually to fit the individual requirements for the patient. | The NobelProcera® Zirconia Implant Bridges are customized dental implant bridges. The implant Bridge attaches directly to the endosseous dental implants and/or onto Nobel Biocare's Multi-unit Abutments with prosthetic screws and provides a platform for restoration. The NobelProcera® Zirconia Implant Bridges are designed and made individually to fit the individual requirements for the patient. | Same as Predicate | | | | | Subject Device | Predicate Device | Comparison | | | | NobelProcera Zirconia Implant Bridge | NobelProcera Zirconia Implant Bridge | Subject / Predicate | | | | K240346 | K202452 | | | | | NobelProcera® Zirconia Implant Bridges are<br>indicated for a bridge span of 2 to up 14 units,<br>on 2 up to 10 implants. | NobelProcera® Zirconia Implant Bridges are<br>indicated for a bridge span of 2 to up 14 units, on 2<br>up to 10 implants. | | | Indication for Use | | The NobelProcera Zirconia Implant Bridge are<br>indicated for use as a bridge anatomically<br>shaped and/or framework in the treatment of<br>partially or totally edentulous jaws for the<br>purpose of restoring chewing function. | The NobelProcera Zirconia Implant Bridge are<br>indicated for use as a bridge anatomically shaped<br>and/or framework in the treatment of partially or<br>totally edentulous jaws for the purpose of restoring<br>chewing function. | Same as Predicate | | | Technological Characteristics | | | | | Specifications | Device Dimensions / Design | | | | | | Internal Conical<br>Connection | NP, RP, WP | NP, RP, WP | Same as Predicate | | Platform<br>compatibility<br>(Implants) | Internal Tri-Channel<br>Connection | NP, RP, WP, 6.0 | NP, RP, WP, 6.0 | Same as Predicate | | | External Hex<br>Connection | NP, RP, WP | NP, RP, WP | Same as Predicate | | Platform<br>compatibility<br>(Abutments) | Multi-unit Abutment | NP, RP, WP | NP, RP, WP | Same as Predicate | | | Multi-unit Abutment<br>Plus | NP, RP, WP | NP, RP, WP | Same as Predicate | | | Angulated Screw Channel (ASC) | ASC Internal Conical Connection: ASC<br>feature available when the Dental Bridge is<br>used in combination with Internal Conical<br>Connection implants. | ASC Internal Conical Connection: ASC feature<br>available when the Dental Bridge is used in<br>combination with Internal Conical Connection<br>implants. | Same as Predicate | | | | Subject Device<br>NobelProcera Zirconia Implant Bridge | Predicate Device<br>NobelProcera Zirconia Implant Bridge | Comparison<br>Subject / Predicate | | | | K240346 | K202452 | | | | | ASC Multi-unit Abutment: ASC feature<br>available when Dental Bridge is used in<br>combination with Multi-unit Abutment and<br>Multi-unit Abutment Plus. | ASC Multi-unit Abutment: ASC feature available<br>when Dental Bridge is used in combination with<br>Multi-unit Abutment and Multi-unit Abutment Plus. | | | Angulated Screw Channel (ASC):<br>Angulation | | 0° to 25° | 0° to 25° | Same as Predicate | | Wall thickness | | Min. 0.4mm | Min. 0.4mm | Same as Predicate | | Attachment method to implant | | Screw retained | Screw retained | Same as Predicate | | Attachment method to abutment | | Screw retained | Screw retained | Same as Predicate | | Restoration type | | Individualized full anatomic contour or<br>framework | Individualized full anatomic contour or framework | Same as Predicate | | Dental Bridge Design | | 2 to 14 units | 2 to 14 units | Same as Predicate | | Number of Implants per Dental<br>Bridge | | 2 to 10 implants | 2 to 10 implants | Same as Predicate | | Free hanging arc length | | Max. 35mm | Max. 35mm | Same as Predicate | | Divergence<br>angle* | Internal Conical<br>Connection | Max. 30° | Max. 30° | Same as Predicate | | | Internal Tri-Channel<br>Connection | Max. 30° | Max. 30° | Same as Predicate | | | External Hex<br>Connection | Max. 20° | Max. 20° | Same as Predicate | | | Multi-unit Abutment<br>Multi-unit Abutment<br>Plus | Max. 45° | Max. 45° | Same as Predicate | | Distance between implants | | Min. 1.2mm | Min. 1.2mm | Same as Predicate | | Max. Extension Length | | 16mm | 10mm | Similar to Predicate, the<br>worst case was selected and<br>fatigue testing was performed | | | | Subject Device | Predicate Device | Comparison | | | | NobelProcera Zirconia Implant Bridge | NobelProcera Zirconia Implant Bridge | Subject / Predicate | | | | K240346 | K202452 | | | | | | | to demonstrate that the<br>difference does not raise<br>different questions of safety<br>and effectiveness | | Surface<br>Treatment | Prosthetic Screw | DLC (Diamond Like Carbon) coating | DLC (Diamond Like Carbon) coating | Same as Predicate | | Material | Dental Bridge | Zirconium Oxide | Zirconium Oxide | Same as Predicate | | | | Yttria-stabilized tetragonal zirconia (Y-TZP)<br>(ISO 13356) | Yttria-stabilized tetragonal zirconia (Y-TZP)<br>(ISO 13356) | Same as Predicate | | | Prosthetic Screw | Titanium aluminum vanadium alloy | Titanium aluminum vanadium alloy | Same as Predicate | | | | Ti6Al4V ELI (ISO 5832-3, ASTM F136) | Ti6Al4V ELI (ISO 5832-3, ASTM F136) | Same as Predicate | | Equipment for digital design<br>workflow |…