(90 days)
No
The description mentions digital design and CAD/CAM software, which are standard digital manufacturing processes, but does not mention any AI or ML capabilities for design optimization, analysis, or other functions.
Yes
The device is intended for "restoring chewing function" and provides support and load dispersion for prosthetic devices in patients with edentulous jaws, which directly addresses a health condition.
No
The device, BellaTek Bars, is an attachment used for restoring chewing function in patients with partially or fully edentulous jaws by dispersing the load of a prosthesis across dental implant-abutment assemblies. It is a restorative device, not one used for diagnosis.
No
The device description clearly states the BellaTek Bars are physical components manufactured from titanium, intended to be implanted in the jaw. While CAD/CAM software is used in the design process, the device itself is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore chewing function in partially or fully edentulous jaws by providing attachments for prosthetic devices. This is a mechanical function within the body.
- Device Description: The device is a physical bar made of titanium or titanium alloy, designed to disperse load and support prosthetics. It is manufactured based on patient-specific scans.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens derived from the human body.
- Performance Studies: The performance studies focus on mechanical properties, sterilization, biocompatibility, and MRI compatibility, which are typical for implantable or prosthetic devices, not IVDs.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
NHA
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 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.
Type I Bars: Removable:
- Platform Seating Diameter: Minimum 3.4mm, Maximum 6.1mm
- Total Cylinders: Minimum 2, Maximum 10
- Bar Span Between Cylinders: Minimum 0mm, Maximum 27mm
- Bar Height: Minimum 2.5mm, Maximum 10mm
- Bar Width: Minimum 1.8mm, Maximum 10mm
- Distal Extension: Minimum 0mm, Maximum 10.7mm
- Cylinder Height: Minimum 0mm, Maximum 10mm
- Cylinder Diameter: Minimum 3.4mm, Maximum 10mm
- Maximum Angulation Between Cylinders: Minimum 0°, Maximum 30°
Type II Bars: Fixed:
- Platform Seating Diameter: Minimum 3.4mm, Maximum 6.1mm
- Total Cylinders: Minimum 2, Maximum 10
- Bar Span Between Cylinders: Minimum 0mm, Maximum 23.5mm
- Bar Height: Minimum 2.5mm, Maximum 22mm
- Bar Width: Minimum 4.0mm, Maximum 10mm
- Distal Extension: Minimum 0mm, Maximum 18mm
- Cylinder Height: Minimum 0mm, Maximum 19.5mm
- Cylinder Diameter: Minimum 3.4mm, Maximum 10mm
- Maximum Angulation Between Cylinders: Minimum 0°, Maximum 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical and/or digital scanner system
Anatomical Site
partially or fully edentulous jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K080864, K180998, K231434, K092341, K111853
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
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)
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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 | |||||
| BellaTek Bars | |||||
| K241032 | Osteon | ||||
| Precision Milled | |||||
| Suprastructure | |||||
| K233083 | Biomet 3i | ||||
| CAM StructSURE® Precision | |||||
| Milled Bars | |||||
| K080864 | BioHorizons Implant | ||||
| Systems, Inc. | |||||
| CAD/CAM Bars | |||||
| K180998 | |||||
| Intended 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 30°
• ZimVie Eztetic
Implant System | The Osteon Precision
Milled Suprastructure is
indicated for attachment
to dental abutments in the
treatment of partially or
fully edentulous jaws for
the purpose of restoring
chewing function. The
Osteon Precision Milled
Suprastructures are
intended for attachment
to a minimum of two (2)
abutments.
The Osteon Milled
Suprastructure is
indicated for compatibility
with the following
abutment systems:
• Astra Tech Implant
System® Multi Base
Abutment EV, 4.8mm,
max 30°
• BioHorizons Multi Unit
Abutment, 4.8mm, max
30°
• CONELOG® Implant
System
• Biomet 3i Multi Unit
Abutments, 4.8mm, max
30° | The CAM StructSURE
Precision Milled Bars are
intended for use as an
accessory to an endosseous
dental implant to support a
prosthetic device in a
partially or edentulous
patient. It is intended for use
to support multiple tooth
prostheses in the mandible
or maxilla. The prostheses
can be screw retained. | BioHorizons CAD/CAM
Bars are intended for
use as superstructures
of a multiple-unit
endosseous dental
implant system,
attaching directly to
implants or abutments
in the mandible or
maxilla, to support a
prosthetic device in a
partially or fully
endentulous patient for
the purpose of restoring
chewing function.
Implant-level bars are
compatible with all
BioHorizons Internal
and Tapered Internal
implant systems.
Implant-level bars are
compatible with Zimmer
Dental Screw-Vent®
and Tapered Screw
Vent® implants with
3.5mm, 4.5mm and
5.7mm internal hex
connection mating
platform diameters and
are intended to be used
with straight bar
cylinders only | |
| | | | | | |
| • ZimVie TSX Implant
System | • Tapered Screw-Vent
Implant | Abutment-level bars are
compatible with
BioHorizons Multi-unit
Abutments.
All digitally designed
BioHorizons CAD/CAM
Bars are intended to be
sent to a BioHorizons-
validated milling center
for manufacture. | | | |
| • ZimVie Tapered
Screw-Vent System | • DESS Dental Multi Unit
Abutments, 3.4-5.7 mm,
0° | | | | |
| • ZimVie Low Profile
Abutments, 3.4-
6.0mm, Angled, max
30° | • 3i OSSEOTITE® | | | | |
| • ZimVie Osseotite
Implant System | • Astra Tech
OsseoSpeed™ | | | | |
| • ZimVie T3 and T3
PRO Implant
System | • Neodent Grand Morse | | | | |
| • ZimVie Tapered
Abutments, 3.5-
5.7mm, Angled, max
30° | • NobelReplace®
Trilobe | | | | |
| • ZimVie TSX Implant
System | • NobelReplace®
Conical | | | | |
| • ZimVie Tapered
Screw-Vent Implant
System | • Nobel Brånemark
System® | | | | |
| | • Straumann BLX
Implants | | | | |
| | • DESS Dental Multi Unit
Abutments, Angled, 3.4-
6.5 mm, max 30° | | | | |
| | • NobelActive®
NobelParallel Conical | | | | |
| | • Straumann® Bone
Level | | | | |
| | • 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 Unit
Abutment, 4.8mm, 0° | | | | |
| | • Medentika Multi Unit
Abutments, 4.8mm, max
30° | | | | |
| | • EV Series –
Dentsply® Implants
Astratech
Osseospeed® | | | | |
| | • F Series - Nobel
Biocare NobelActive® –
NobelReplace® Conical | | | | |
| | • H Series – Biomet 3i
Certain® | | | | |
| | • L Series – Straumann
Bone Level | | | | |
| | | • N Series – Straumann | Soft tissue Level | | |
| | • R Series – Zimmer
Dental Tapered
Screwvent® | | | | |
| | • Medentika Multi Unit
Abutments, 4.8mm, 0° | | | | |
| | • E Series – Nobel
Biocare Replace™
Select | | | | |
| | • I Series – Biomet 3i
Osseotite® | | | | |
| | • K Series – Nobel
Biocare™ Branemark | | | | |
| | • S Series – Astra Tech
OsseoSpeed™ | | | | |
| | • T Series – Dentsply
Friadent® Frialit/Xive® | | | | |
| | • MegaGen Multi Unit | | | | |
Table 3. Summary Table of Substantial Equivalence
7
K241032
8
| 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) |
9
K241032
| | | Implants, 0°
• Piccolo Implants, 0°
• External Hex Implants,
max 30°
• Straumann® BLX Screw
Retained Abutment, 4.6
mm, max 30°
• Straumann® Screw
Retained Abutment, 4.6
mm, max 30°
• Zimmer Angled Tapered
Abutments, 4.5 mm, max
30° | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Design | | | | |
| Bar shape | Type I (Dolder, Hader,
Primary)
Type II (Hybrid,
Wrap around, Freeform,
Canada, CopyMilled) | Type A (for Removable
Prosthesis)
Type B (for Fixed
Prosthesis) | Type I (Dolder, Hader,
Primary)
Type II (Combination Primary,
Hybrid,
Wrap around, Freeform,
Canada, CopyMilled) | Fixed shape (Dolder®,
Hader, Round) Freeform
shape (Freeform/Milled,
Hybrid,
Montreal, Paris, Wrap
Around) |
| Platform seating
diameter | 3.4mm - 6.1mm | 4.5mm – 8.0mm | 3.4mm - 6.1mm | 3.0mm, 3.5mm, 4.5mm,
5.7mm |
| Min. number of
cylinders | 2 | 2 | 2 | 2 |
| Max.
anterior-
posterior
spread | 40mm | Not specified | 40mm | Not specified |
| Max. implant span | 27mm (Type I)
23.5mm (Type II) | 30mm (Type A and Type
B) | 27mm (Type I)
23.5mm (Type II) | 30mm |
| Mode of retention | Screw-retained | Screw-retained | Screw-retained | Screw-retained |
| Mating
components | Multi-unit Abutments
manufactured by Terrats
Medical SL | Straight, angled and multi-
unit abutments
manufactured by various
Original Equipment
Manufacturers | Multi-unit Abutments
manufactured by Biomet 3i
LLC | Multi-unit Abutments
manufactured by
BioHorizons Implant
Systems Inc. |
| Material and Manufacturing | | | | |
| Bar material | Ti-6Al-4V ELI (ASTM
F136) or
Grade 4 CP Titanium
(ASTM F67) | Ti-6Al-4V ELI (ASTM
F136) | Ti-6Al-4V ELI (ASTM F136) or
Grade 4 CP Titanium
(ASTM F67) | Ti-6Al-4V ELI (ASTM
F136) |
| Packaging | Nylon pouch | Not specified | Nylon pouch | Poly/Tyvek pouch |
| Sterilization | Moist heat | End-user (methodology
not 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.
10
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.