BellaTek Bars

{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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 15, 2024 Biomet 3i, LLC % Michael Davis Principal Consultant Michael Davis Quality and Regulatory Consulting, LLC 204 Norwick Forest Drive Alabaster, Alabama 35007 Re: K241032 Trade/Device Name: BellaTek® Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 15, 2024 Received: April 16, 2024 Dear Michael Davis: 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. 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/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 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 510(k) Number (if known) K241032 Device Name BellaTek Bars Indications for Use (Describe) The BellaTek Bars are indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments. All digitally designed BellaTek Bars are intended to be sent to Biomet 3i for manufacture. The BellaTek Bars are indicated for compatibility with the following abutment systems: · Universal Multi-Unit Abutments manufactured by Terrats Medical SL., 2.9-5.7mm, Angled, max 30 degrees - · ZimVie Eztetic Implant System - · ZimVie TSX Implant System - · ZimVie Tapered Screw-Vent System - · ZimVie Low Profile Abutments, 3.4-6.0mm, Angled, max 30 degrees - · ZimVie Osseotite Implant System - ZimVie T3 and T3 PRO Implant System - · ZimVie Tapered Abutments, 3.5-5.7mm, Angled, max 30 degrees - · ZimVie TSX Implant System - · ZimVie Tapered Screw-Vent Implant System | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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}------------------------------------------------ #### BellaTek® Bars 510(k) Summary 21 CFR 807.92 07/15/2024 #### Submitter's Name & Address | Manufacturer: | Biomet 3i, LLC | |-------------------|------------------------------| | | 4555 Riverside Drive | | | Palm Beach Gardens, FL 33410 | | | Phone (561) 776-6700 | | Official contact: | Krupal Patel | | Job Title: | Regulatory Affairs Principal | | Email: | krupal.patel@zimvie.com | #### Name of the Device | Trade Name: | BellaTek® Bars | |------------------------|------------------------------------| | Common or Usual Name: | Dental implant abutment | | Classification Name: | Endosseous dental implant abutment | | Classification Number: | Class II (21 CFR 872.3630) | | Primary Product Code: | NHA | #### Predicate Devices Primary Predicate Device: K233083, Osteon Precision Milled Suprastructure, March 9, 2024 Reference Predicate Device: K080864. Biomet 3i CAM StructSURE® Precision Milled Bars, July 21. 2008 K180998, BioHorizons CAD/CAM Bars, September 28, 2018 K231434, Terrats Medical Dental Smart Solutions Abutments, August 14, 2023 K092341, Biomet 3i Low Profile Abutments - Internal and External Connection, November 30, 2009 K111853, Zimmer Dental Angled Tapered Abutments, December 8, 2011 ## Device Description The BellaTek Bars are intended to disperse the load of a prosthesis across dental implant-abutment assemblies. They also provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The subject devices are identical to the reference predicate device CAM StructSURE Precision Milled Bars cleared in K080864 (SE 07/21/2008) with the only addition of the new connection geometry. The subject device has a new bar-to-abutment connection tailored to the multi-unit restorative abutment component(s) with which the device is intended to be used. Similar to the primary predicate device (K233083), the BellaTek Bars are manufactured out of commercially pure titanium per ASTM F67 or Titanium Alloy per ASTM F136. The BellaTek Bars are placed in a nylon bag and sealed in same manner as the reference predicate device (K080864). A label is applied to the bag. Like the primary predicate device (K233083), the BellaTek Bars are offered in two types. A Type I Bar is a Titanium Alloy bar designed for use with removable overdentures. A Type II Bar is a Pure Titanium or Titanium Alloy bar designed for fixed prosthesis. All BellaTek Bars (Dolder, Primary, Hader, Hybrid, Freeform, Canada, Wraparound and Copy Milled) are designed to match an individual {5}------------------------------------------------ patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then is machined using a CAD/CAM software system in accordance with customer specifications, within the limits of design defined in tables below. The subject devices are provided non-sterile in same manner as the predicate devices. Below are the design matrix specifications that serve as instructions and limitations for the design of each bar. The design specifications for the subject BellaTek Bars included in the tables below are identical to the reference predicate CAM StructSURE Precision Milled Bars. | Description | Minimum | Maximum | |--------------------------------------|---------|---------| | Platform Seating Diameter | 3.4mm | 6.1mm | | Total Cylinders | 2 | 10 | | Bar Span Between Cylinders | 0mm | 27mm | | Bar Height | 2.5mm | 10mm | | Bar Width | 1.8mm | 10mm | | Distal Extension | 0mm | 10.7mm | | Cylinder Height | 0mm | 10mm | | Cylinder Diameter | 3.4mm | 10mm | | Maximum Angulation Between Cylinders | 0° | 30° | ## Table 1: Type | Bars: Removable ## Table 2: Type II Bars: Fixed | Description | Minimum | Maximum | |--------------------------------------|---------|---------| | Platform Seating Diameter | 3.4mm | 6.1mm | | Total Cylinders | 2 | 10 | | Bar Span Between Cylinders | 0mm | 23.5mm | | Bar Height | 2.5mm | 22mm | | Bar Width | 4.0mm | 10mm | | Distal Extension | 0mm | 18mm | | Cylinder Height | 0mm | 19.5mm | | Cylinder Diameter | 3.4mm | 10mm | | Maximum Angulation Between Cylinders | 0° | 30° | The BellaTek Bars are provided with an abutment-level connection interface. The BellaTek Bars include passive, non-indexing connection geometry with seating on the restorative platform of the multi-unit abutment as well as incorporate a screw seat that allows passage through and fixation with a Universal Multi-Unit prosthetic screw. Combined with intaglio-side connection geometry, the prosthetic screw secures the device to the underlying multi-unit abutment. Additionally, the occlusal surface of the BellaTek Bars may include connection geometry (e.g. female threads) to accept overdenture attachments. #### Indications for Use The BellaTek Bars are indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments. All digitally designed BellaTek Bars are intended to be sent to Biomet 3i for manufacture. The BellaTek Bars are indicated for compatibility with the following abutment systems: - Universal Multi-Unit Abutments manufactured by Terrats Medical SL., 2.9-5.7mm, Angled, max 300 ● - ZimVie Eztetic Implant System ● - ZimVie TSX Implant System . - ZimVie Tapered Screw-Vent System ● {6}------------------------------------------------ - ZimVie Low Profile Abutments, 3.4-6.0mm, Angled, max 30° ● - ZimVie Osseotite Implant System - . ZimVie T3 and T3 PRO Implant System - . ZimVie Tapered Abutments, 3.5-5.7mm, Angled, max 300 - ZimVie TSX Implant System - ZimVie Tapered Screw-Vent Implant System . #### Summary of the Technological Characteristics The fundamental scientific technology of the BellaTek Bars that are the subject of this 510(k) is substantially equivalent to the primary predicate device (K233083). Both the subject device and reference predicate device (K080864) include similar features such as bar base material, bar-toabutment connection tailored to the multi-unit restorative abutment component(s) with which the device is intended to be used, prosthetic platform sizes and mode of prosthetic retention which thereby demonstrates substantial equivalence in their respective designs. Any specific differences related to prosthetic platform connection geometry are supported by the identified predicate devices. The subject device is substantially equivalent to the primary predicate device in intended use, design principles and technological characteristics. The features, base materials, similarities and differences are further summarized in tabular format in the Summary Table of Substantial Equivalence following in this section. The Indications for Use statement for the subject device is substantially equivalent to that of the primary predicate device, except for the list of identified compatible abutment systems. The reference predicate devices (K231434. K092341 and K111853) are included for the purpose of identifying OEM abutment compatibility. | | Subject Device | Primary Predicate Device | Reference Predicate Device(s) | | | |----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | Biomet 3i<br>BellaTek Bars<br>K241032 | Osteon<br>Precision Milled<br>Suprastructure<br>K233083 | Biomet 3i<br>CAM StructSURE® Precision<br>Milled Bars<br>K080864 | BioHorizons Implant<br>Systems, Inc.<br>CAD/CAM Bars<br>K180998 | | | Intended Use | The BellaTek Bars are<br>indicated for attachment<br>to dental abutments in<br>the treatment of partially<br>or fully edentulous jaws<br>for the purpose of<br>restoring chewing<br>function. The BellaTek<br>Bars are intended for<br>attachment to a<br>minimum of two (2)<br>abutments.<br><br>All digitally designed<br>BellaTek Bars are<br>intended to be sent to<br>Biomet 3i for<br>manufacture.<br><br>The BellaTek Bars are<br>indicated for compatibility<br>with the following<br>abutment systems:<br>• Universal Multi-Unit<br>Abutments<br>manufactured by<br>Terrats Medical SL.,<br>2.9-5.7mm, Angled,<br>max 30°<br>• ZimVie Eztetic<br>Implant System | The Osteon Precision<br>Milled Suprastructure is<br>indicated for attachment<br>to dental abutments in the<br>treatment of partially or<br>fully edentulous jaws for<br>the purpose of restoring<br>chewing function. The<br>Osteon Precision Milled<br>Suprastructures are<br>intended for attachment<br>to a minimum of two (2)<br>abutments.<br><br>The Osteon Milled<br>Suprastructure is<br>indicated for compatibility<br>with the following<br>abutment systems:<br>• Astra Tech Implant<br>System® Multi Base<br>Abutment EV, 4.8mm,<br>max 30°<br>• BioHorizons Multi Unit<br>Abutment, 4.8mm, max<br>30°<br>• CONELOG® Implant<br>System<br>• Biomet 3i Multi Unit<br>Abutments, 4.8mm, max<br>30° | The CAM StructSURE<br>Precision Milled Bars are<br>intended for use as an<br>accessory to an endosseous<br>dental implant to support a<br>prosthetic device in a<br>partially or edentulous<br>patient. It is intended for use<br>to support multiple tooth<br>prostheses in the mandible<br>or maxilla. The prostheses<br>can be screw retained. | BioHorizons CAD/CAM<br>Bars are intended for<br>use as superstructures<br>of a multiple-unit<br>endosseous dental<br>implant system,<br>attaching directly to<br>implants or abutments<br>in the mandible or<br>maxilla, to support a<br>prosthetic device in a<br>partially or fully<br>endentulous patient for<br>the purpose of restoring<br>chewing function.<br><br>Implant-level bars are<br>compatible with all<br>BioHorizons Internal<br>and Tapered Internal<br>implant systems.<br><br>Implant-level bars are<br>compatible with Zimmer<br>Dental Screw-Vent®<br>and Tapered Screw<br>Vent® implants with<br>3.5mm, 4.5mm and<br>5.7mm internal hex<br>connection mating<br>platform diameters and<br>are intended to be used<br>with straight bar<br>cylinders only | | | | | | | | | | • ZimVie TSX Implant<br>System | • Tapered Screw-Vent<br>Implant | Abutment-level bars are<br>compatible with<br>BioHorizons Multi-unit<br>Abutments.<br>All digitally designed<br>BioHorizons CAD/CAM<br>Bars are intended to be<br>sent to a BioHorizons-<br>validated milling center<br>for manufacture. | | | | | • ZimVie Tapered<br>Screw-Vent System | • DESS Dental Multi Unit<br>Abutments, 3.4-5.7 mm,<br>0° | | | | | | • ZimVie Low Profile<br>Abutments, 3.4-<br>6.0mm, Angled, max<br>30° | • 3i OSSEOTITE® | | | | | | • ZimVie Osseotite<br>Implant System | • Astra Tech<br>OsseoSpeed™ | | | | | | • ZimVie T3 and T3<br>PRO Implant<br>System | • Neodent Grand Morse | | | | | | • ZimVie Tapered<br>Abutments, 3.5-<br>5.7mm, Angled, max<br>30° | • NobelReplace®<br>Trilobe | | | | | | • ZimVie TSX Implant<br>System | • NobelReplace®<br>Conical | | | | | | • ZimVie Tapered<br>Screw-Vent Implant<br>System | • Nobel Brånemark<br>System® | | | | | | | • Straumann BLX<br>Implants | | | | | | | • DESS Dental Multi Unit<br>Abutments, Angled, 3.4-<br>6.5 mm, max 30° | | | | | | | • NobelActive®<br>NobelParallel Conical | | | | | | | • Straumann® Bone<br>Level | | | | | | | • Zimmer Screw Vent®<br>and Tapered Screw-<br>Vent® | | | | | | | • Dentium SuperLine®<br>Abutments, 4.5-5.5 mm,<br>max30° | | | | | | | • GENESIS ACTIVE™<br>Multi-Unit Abutments,<br>4.8mm, max 30° | | | | | | | • Implant Direct GPS®<br>Angled Abutment, 5.0mm,<br>max 30° | | | | | | | • KDG Abutments,<br>4.8mm, max 30° | | | | | | | • Keystone Multi Unit<br>Abutment, 4.8mm, 0° | | | | | | | • Medentika Multi Unit<br>Abutments, 4.8mm, max<br>30° | | | | | | | • EV Series –<br>Dentsply® Implants<br>Astratech<br>Osseospeed® | | | | | | | • F Series - Nobel<br>Biocare NobelActive® –<br>NobelReplace® Conical |…