(90 days)
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 .
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 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.
The BellaTek Bars are dental implant abutments intended to restore chewing function in partially or fully edentulous jaws by attaching to a minimum of two abutments.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are primarily aligned with demonstrating substantial equivalence to a predicate device through materials, design specifications, and performance bench testing. Specific quantitative performance targets are not explicitly listed in an "acceptance criteria" table format in the provided document, but rather implied through comparison to existing standards and predicate devices.
| Acceptance Criteria Category | Description and Reported Device Performance |
|---|---|
| Intended Use | Substantially equivalent to the primary predicate device (K233083). – BellaTek Bars: Indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and manufactured by Biomet 3i. – Predicate Device (Osteon Precision Milled Suprastructure K233083): Indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and manufactured by Osteon. |
| Design Principles & Technological Characteristics | Substantially equivalent to the primary predicate device (K233083) and reference predicate device (K080864). - Similar features: bar base material, bar-to-abutment connection, prosthetic platform sizes, mode of prosthetic retention. - Differences in prosthetic platform connection geometry are supported by identified predicate devices. |
| Material and Manufacturing | Bar Material: Ti-6Al-4V ELI (ASTM F136) or Grade 4 CP Titanium (ASTM F67). - Meets chemical and mechanical requirements of ASTM F136 and ASTM F67. - Packaging: Nylon pouch. - Sterilization Process: Moist heat, validated according to EN ISO 17665-1:2006 to achieve a sterility assurance level (SAL) of 10-6. |
| Biocompatibility | Testing performed according to ISO 10993-1:2018 and ISO 10993-5:2009 on representative Biomet 3i patient-specific bar devices using the same ASTM F136 titanium alloy and ASTM F67 unalloyed titanium materials. - Concluded that the material, chemical testing, and literature provide sufficient basis for demonstrating biocompatibility. |
| MRI Safety | Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods et al., 2019). - Addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. - Reported Performance: BellaTek Bars have been labeled as MR conditional. |
| Performance Bench Testing | Worst-case design validated in accordance with Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004. - Demonstrates that differences from the predicate are accounted for and do not render the device not substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or cases. The document refers to "worst case design" being validated. For sterilization, the validation process implies testing units to demonstrate SAL. For biocompatibility, "representative Biomet 3i patient-specific bar devices" were used. For MRI review, it was a "non-clinical worst-case MRI review... based on the entire system including all variations." This suggests a methodology of evaluating design limits and material properties rather than a large clinical test set.
- Data Provenance: The studies are non-clinical (bench testing, material analysis, literature review, MRI rationale). No specific country of origin for non-clinical data is mentioned, but the standards followed (e.g., ASTM, ISO, EN ISO) are international. The studies are by nature prospective as they are conducted to support the specific device submission, but they leverage established scientific literature and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the studies are non-clinical bench tests, material characterizations, and literature reviews, the concept of "experts establishing ground truth for a test set" in a clinical diagnostic sense does not directly apply. The "ground truth" for these types of studies is established by:
- Regulatory Standards: Adherence to recognized standards like ASTM F136, ASTM F67, ISO 10993-1, ISO 10993-5, EN ISO 17665-1, and FDA guidance documents.
- Engineering and Scientific Expertise: The performance of bench tests, material analysis, and MRI safety assessments would be conducted by engineers, material scientists, and physicists with expertise in these areas. While individual names or specific numbers aren't listed, this expertise is inherent in conducting such tests.
- Literature: The MRI safety assessment explicitly mentions using "published literature" as part of its scientific rationale, implying leveraging the consensus of experts in that field.
No specific number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience") are provided in the context of establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in clinical studies where subjective interpretation is involved (e.g., image reading). The studies described here are non-clinical, objective evaluations (bench testing, material analysis).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No. The provided document states: "No clinical data were included in this submission." Therefore, no MRMC study or AI assistance evaluation was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical dental implant bar, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Regulatory Standards and Specifications: Adherence to performance parameters detailed in FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"), and international standards (ASTM, ISO, EN ISO).
- Material Properties: Data derived from chemical and mechanical testing of the materials (ASTM F136, ASTM F67).
- Biocompatibility Endpoints: Established biological safety endpoints defined by ISO 10993 standards.
- MRI Safety Rationale: Scientific principles and published literature related to magnetic fields and medical devices.
- Demonstration of Substantial Equivalence: Direct comparison of technological characteristics and performance to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are developed through traditional engineering methods and validated through the testing described.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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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
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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)
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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 ●
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- 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 3iBellaTek BarsK241032 | OsteonPrecision MilledSuprastructureK233083 | Biomet 3iCAM StructSURE® PrecisionMilled BarsK080864 | BioHorizons ImplantSystems, Inc.CAD/CAM BarsK180998 | ||
| Intended Use | The BellaTek Bars areindicated for attachmentto dental abutments inthe treatment of partiallyor fully edentulous jawsfor the purpose ofrestoring chewingfunction. The BellaTekBars are intended forattachment to aminimum of two (2)abutments.All digitally designedBellaTek Bars areintended to be sent toBiomet 3i formanufacture.The BellaTek Bars areindicated for compatibilitywith the followingabutment systems:• Universal Multi-UnitAbutmentsmanufactured byTerrats Medical SL.,2.9-5.7mm, Angled,max 30°• ZimVie EzteticImplant System | The Osteon PrecisionMilled Suprastructure isindicated for attachmentto dental abutments in thetreatment of partially orfully edentulous jaws forthe purpose of restoringchewing function. TheOsteon Precision MilledSuprastructures areintended for attachmentto a minimum of two (2)abutments.The Osteon MilledSuprastructure isindicated for compatibilitywith the followingabutment systems:• Astra Tech ImplantSystem® Multi BaseAbutment EV, 4.8mm,max 30°• BioHorizons Multi UnitAbutment, 4.8mm, max30°• CONELOG® ImplantSystem• Biomet 3i Multi UnitAbutments, 4.8mm, max30° | The CAM StructSUREPrecision Milled Bars areintended for use as anaccessory to an endosseousdental implant to support aprosthetic device in apartially or edentulouspatient. It is intended for useto support multiple toothprostheses in the mandibleor maxilla. The prosthesescan be screw retained. | BioHorizons CAD/CAMBars are intended foruse as superstructuresof a multiple-unitendosseous dentalimplant system,attaching directly toimplants or abutmentsin the mandible ormaxilla, to support aprosthetic device in apartially or fullyendentulous patient forthe purpose of restoringchewing function.Implant-level bars arecompatible with allBioHorizons Internaland Tapered Internalimplant systems.Implant-level bars arecompatible with ZimmerDental Screw-Vent®and Tapered ScrewVent® implants with3.5mm, 4.5mm and5.7mm internal hexconnection matingplatform diameters andare intended to be usedwith straight barcylinders only | |
| • ZimVie TSX ImplantSystem | • Tapered Screw-VentImplant | Abutment-level bars arecompatible withBioHorizons Multi-unitAbutments.All digitally designedBioHorizons CAD/CAMBars are intended to besent to a BioHorizons-validated milling centerfor manufacture. | |||
| • ZimVie TaperedScrew-Vent System | • DESS Dental Multi UnitAbutments, 3.4-5.7 mm,0° | ||||
| • ZimVie Low ProfileAbutments, 3.4-6.0mm, Angled, max30° | • 3i OSSEOTITE® | ||||
| • ZimVie OsseotiteImplant System | • Astra TechOsseoSpeed™ | ||||
| • ZimVie T3 and T3PRO ImplantSystem | • Neodent Grand Morse | ||||
| • ZimVie TaperedAbutments, 3.5-5.7mm, Angled, max30° | • NobelReplace®Trilobe | ||||
| • ZimVie TSX ImplantSystem | • NobelReplace®Conical | ||||
| • ZimVie TaperedScrew-Vent ImplantSystem | • Nobel BrånemarkSystem® | ||||
| • Straumann BLXImplants | |||||
| • DESS Dental Multi UnitAbutments, Angled, 3.4-6.5 mm, max 30° | |||||
| • NobelActive®NobelParallel Conical | |||||
| • Straumann® BoneLevel | |||||
| • Zimmer Screw Vent®and Tapered Screw-Vent® | |||||
| • Dentium SuperLine®Abutments, 4.5-5.5 mm,max30° | |||||
| • GENESIS ACTIVE™Multi-Unit Abutments,4.8mm, max 30° | |||||
| • Implant Direct GPS®Angled Abutment, 5.0mm,max 30° | |||||
| • KDG Abutments,4.8mm, max 30° | |||||
| • Keystone Multi UnitAbutment, 4.8mm, 0° | |||||
| • Medentika Multi UnitAbutments, 4.8mm, max30° | |||||
| • EV Series –Dentsply® ImplantsAstratechOsseospeed® | |||||
| • F Series - NobelBiocare NobelActive® –NobelReplace® Conical | |||||
| • H Series – Biomet 3iCertain® | |||||
| • L Series – StraumannBone Level | |||||
| • N Series – Straumann | Soft tissue Level | ||||
| • R Series – ZimmerDental TaperedScrewvent® | |||||
| • Medentika Multi UnitAbutments, 4.8mm, 0° | |||||
| • E Series – NobelBiocare Replace™Select | |||||
| • I Series – Biomet 3iOsseotite® | |||||
| • K Series – NobelBiocare™ Branemark | |||||
| • S Series – Astra TechOsseoSpeed™ | |||||
| • T Series – DentsplyFriadent® Frialit/Xive® | |||||
| • MegaGen Multi Unit |
Table 3. Summary Table of Substantial Equivalence
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K241032
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| Abutments, 4.8mm, max | ||
|---|---|---|
| 30° | ||
| • Xpeed® AnyRidge® | ||
| Internal Implant System• AnyOne® Internal | ||
| Implant System | ||
| • AnyRidge® Octa 1 | ||
| Implant System | ||
| • AnyOne® External | ||
| Implant System | ||
| • AnyRidge® Octa 1 | ||
| Implant System | ||
| • AnyOne® Internal | ||
| Implant System | ||
| • Rescue Internal | ||
| Implant System• MIS Multi-unit | ||
| Abutments, 4.8mm | ||
| • C1 Conical | ||
| Connection Implant | ||
| System, max 30° | ||
| • V3 Conical | ||
| Connection Implant | ||
| System, max 30° | ||
| • Internal Hex Implant | ||
| System, max 30° | ||
| · Conical Connection, | ||
| max 30°• Neodent GM Mini | ||
| Conical Abutment, 4.8 | ||
| mm, max 30° | ||
| · Nobel Biocare™ | ||
| Brånemark Multi Unit | ||
| Abutment, 4.8 mm, max | ||
| 17° | ||
| • Nobel Biocare™ Multi | ||
| Unit Abutment Plus, 4.8 | ||
| mm, max 30° | ||
| • Nobel Biocare™ Multi | ||
| Unit Abutment, 4.8 mm,max 30° | ||
| • Nobel Biocare™ Multi | ||
| Unit Abutments for | ||
| Straumann and Astra | ||
| Tech System, 4.8 mm, | ||
| max 30° | ||
| • Nobel Biocare™ Multi | ||
| Unit Abutments for Astra | ||
| Tech, Camlog and | ||
| Ankylos Implant Systems, | ||
| 4.8 mm, max 30°• Nobel Biocare Xeal | ||
| Abutments, 4.8 mm, max | ||
| 30° | ||
| • OSSTEM Multi Unit | ||
| Abutment, 4.8mm, max | ||
| 30° | ||
| • SS SA Fixture | ||
| Implants | ||
| • SA Implant System | ||
| • ET US SSS Prosthetic | ||
| System• Paltop Multi Unit | ||
| Abutment, 5.0 mm, max | ||
| 17° | ||
| • Southern Compact | ||
| Conical Abutments, 4.8 | ||
| mm | ||
| • MAX Implant System, | ||
| 0° | ||
| • Provata Implant | ||
| System, max 30° | ||
| · Deep Conical (DC) |
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K241032
| Implants, 0°• Piccolo Implants, 0°• External Hex Implants,max 30°• Straumann® BLX ScrewRetained Abutment, 4.6mm, max 30°• Straumann® ScrewRetained Abutment, 4.6mm, max 30°• Zimmer Angled TaperedAbutments, 4.5 mm, max30° | ||||
|---|---|---|---|---|
| Design | ||||
| Bar shape | Type I (Dolder, Hader,Primary)Type II (Hybrid,Wrap around, Freeform,Canada, CopyMilled) | Type A (for RemovableProsthesis)Type B (for FixedProsthesis) | Type I (Dolder, Hader,Primary)Type II (Combination Primary,Hybrid,Wrap around, Freeform,Canada, CopyMilled) | Fixed shape (Dolder®,Hader, Round) Freeformshape (Freeform/Milled,Hybrid,Montreal, Paris, WrapAround) |
| Platform seatingdiameter | 3.4mm - 6.1mm | 4.5mm – 8.0mm | 3.4mm - 6.1mm | 3.0mm, 3.5mm, 4.5mm,5.7mm |
| Min. number ofcylinders | 2 | 2 | 2 | 2 |
| Max.anterior-posteriorspread | 40mm | Not specified | 40mm | Not specified |
| Max. implant span | 27mm (Type I)23.5mm (Type II) | 30mm (Type A and TypeB) | 27mm (Type I)23.5mm (Type II) | 30mm |
| Mode of retention | Screw-retained | Screw-retained | Screw-retained | Screw-retained |
| Matingcomponents | Multi-unit Abutmentsmanufactured by TerratsMedical SL | Straight, angled and multi-unit abutmentsmanufactured by variousOriginal EquipmentManufacturers | Multi-unit Abutmentsmanufactured by Biomet 3iLLC | Multi-unit Abutmentsmanufactured byBioHorizons ImplantSystems Inc. |
| Material and Manufacturing | ||||
| Bar material | Ti-6Al-4V ELI (ASTMF136) orGrade 4 CP Titanium(ASTM F67) | Ti-6Al-4V ELI (ASTMF136) | Ti-6Al-4V ELI (ASTM F136) orGrade 4 CP Titanium(ASTM F67) | Ti-6Al-4V ELI (ASTMF136) |
| Packaging | Nylon pouch | Not specified | Nylon pouch | Poly/Tyvek pouch |
| Sterilization | Moist heat | End-user (methodologynot specified) | Moist heat | Moist heat |
The Subject Device worst case design was validated with performance bench testing in accordance with Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, and the differences noted or otherwise not accounted for by comparison to the predicate device are demonstrated by the performance bench testing, and do not render the Subject Device not substantially equivalent.
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Summary of Testing
The BellaTek Bars are provided non-sterile. Sterilization by the end user is achieved using one of the validated steam sterilization cycles as specified in the Instructions for Use. Sterilization cycles were validated in accordance with EN ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, demonstrating a sterility assurance level (SAL) of 10-6 of the device.
Finally, the BellaTek Bars meet the chemical and mechanical requirements of ASTM F136 and ASTM F67. These grades of Titanium are commonly used in surgical implant applications. Biocompatibility testing conducted on representative Biomet 31 patient-specific bar devices that used the same ASTM F136 titanium allov and ASTM F67 unalloved titanium materials was performed in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and ISO 10993-5:2009. Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. These tests concluded that the material, chemical testing and literature reviewed provides sufficient basis for demonstrating the biocompatibility of titanium materials for their intended use in the subject devices.
Non-clinical worst-case MRI review was performed to evaluate the BellaTek Bar devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. The BellaTek Bars have been labeled as MR conditional.
No clinical data were included in this submission.
Conclusion
The data presented in this submission demonstrates that the proposed devices are substantially equivalent with respect to performance and intended use. Non-clinical testing performed demonstrates that the proposed devices perform as well as the legally marketed predicate devices. Furthermore, the proposed devices do not pose any new or increased risks as compared to the legally marketed predicate devices.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)