Tapered Pro Conical Implant System

K240187 · BioHorizons Implant Systems, Inc. · DZE · Jun 5, 2024 · Dental

Device Facts

Record IDK240187
Device NameTapered Pro Conical Implant System
ApplicantBioHorizons Implant Systems, Inc.
Product CodeDZE · Dental
Decision DateJun 5, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. These dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants. BioHorizons Tapered Short Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional. BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.

Device Story

Tapered Pro Conical Implant System consists of endosseous dental implants and prosthetic components for oral rehabilitation. Implants feature tapered screw-shaped design with reverse buttress threads and self-tapping cutting flutes. Surface treatment includes resorbable blast texturing (RBT) with hydroxyapatite media; optional Laser-Lok treatment on collar for tissue attachment. Internal connection is deep conical with six anti-rotation cams. System includes healing components, multi-unit abutments, Ti-Base abutments, and CAD/CAM Ti blanks. Used by dental professionals in clinical settings for single or multiple tooth replacement. Digitally designed abutments require manufacturing at BioHorizons-validated milling centers. Device provides artificial root structure for prosthetic restorations; benefits include functional and esthetic rehabilitation of edentulous or partially edentulous arches.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing: ISO 14801 dynamic loading, sterilization validation (ISO 11137, ISO 17665), bacterial endotoxin testing (ANSI/AAMI ST72), shelf-life testing (ASTM F1929, F88), biocompatibility (ISO 10993), and MRI compatibility (ASTM 2052).

Technological Characteristics

Materials: Ti-6Al-4V ELI alloy (ASTM F136). Surface: RBT (hydroxyapatite blast) and Laser-Lok. Connection: Deep conical with 6 anti-rotation cams. Sterilization: Gamma irradiation (SAL 10^-6) or moist heat. Connectivity: Compatible with CAD/CAM digital workflows via validated milling centers.

Indications for Use

Indicated for patients requiring single tooth replacement, fixed bridgework, or dental retention in the mandible or maxilla. Tapered Short Conical implants are indicated for use when space is limited; requires delayed loading for single tooth replacement. Contraindicated if crown-to-implant ratio is unfavorable without appropriate biomechanical risk mitigation.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". June 5, 2024 BioHorizons Implant Systems Inc. % Floyd Larson President PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, California 92130 Re: K240187 Trade/Device Name: Tapered Pro Conical Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 3, 2024 Received: May 7, 2024 # Dear Floyd Larson: 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}------------------------------------------------ 3 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) K240187 Device Name Tapered Pro Conical Implant System #### Indications for Use (Describe) BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants. BioHorizons Tapered Short Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional. BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span> </span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span> </span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### 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}------------------------------------------------ # 510(k) Summary BioHorizons Implant Systems Inc. Tapered Pro Conical Implant System #### June 5, 2024 #### ADMINISTRATIVE INFORMATION | Manufacturer Name | BioHorizons Implant Systems Inc.<br>2300 Riverchase Center<br>Birmingham, AL 35244<br>Telephone +1 205-967-7880 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Jared Cooper, Ph.D., Director, Regulatory Affairs | | Representative/Consultant | Floyd G. Larson, MS, MBA<br>Kevin A. Thomas, PhD<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: +1 858-792-1235<br>Fax: +1 858-792-1236<br>Email: flarson@paxmed.com; kthomas@paxmed.com | #### DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name | Tapered Pro Conical Implant System | |------------------------|------------------------------------------------------------------------------------------------| | Common Names | Endosseous dental implant | | Regulation Number | 21 CFR 872.3640 | | Regulation Name | Endosseous dental implant | | Regulatory Class | Class 2 | | Product Code | DZE | | Secondary Product Code | NHA | | Classification Panel | Dental | | Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory,<br>ENT and Dental Devices) | | Reviewing Division | Division of Health Technology 1B (Dental and ENT Devices) | ## PREDICATE DEVICE INFORMATION #### Primary Predicate Device K143022, BioHorizons Tapered Internal Implants, BioHorizons Implant Systems Inc. Reference Devices K071638, Tapered Internal Implant System, BioHorizons Implant Systems Inc. K113779, CONELOG Implant System, Altatec GmbH K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems Inc. K172576, Tapered Short Implants, BioHorizons Implant Systems Inc. K193401, Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants, Altatec GmbH K203252, Multi-unit Abutments for CONELOG, BioHorizons Implant Systems Inc. {5}------------------------------------------------ K223697, MRI compatibility for existing BioHorizons dental implants and abutments, BioHorizons Implant Systems Inc. K230108, Straumann® BLC and TLC Implants, Straumann USA, LLC ## INDICATIONS FOR USE STATEMENT BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. These dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants. BioHorizons Tapered Short Conical dental implants are in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length to implant length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional. BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture. ## SUBJECT DEVICE DESCRIPTION The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system, Tapered Pro Conical Implant System, from BioHorizons Implant Systems Inc. The Tapered Pro Conical Implant System includes a range of ental implants and prosthetic components, BioHorizons Tapered Pro Conical implants feature a tapered screw-shaped design with a reverse buttress thread. Cutting flutes are incorporated into the thread to be self-tapping when placed into the prepared surgical site. The outer surface of the implant has been roughened with resorbable blast texturing (RBT) using a hydroxyapatite blast media. Internally, the implant features a deep conical prosthetic connection between implants and abutments with six anti-rotation cams at the base of the connection, intended to interface with the three cams of the prosthetic components. It is available with or without Laser-Lok treatment applied to the collar of the implant. Tapered Pro Conical Implants are available in a range of implant diameters and lengths with two prosthetic platform (implant/abutment connection) sizes, as shown below. Internal surfaces of the Tapered Pro Conical Regular platform implants are anodized yellow to distinguish them from Narrow platform implants. {6}------------------------------------------------ | Implant Line | Image<br>Not to<br>Scale | Body Ø, mm | Apical Ø, mm | Prosthetic Platform | Length, mm | | | | | |----------------------------------------|--------------------------|------------|--------------|---------------------|------------|------|----|----|----| | Tapered<br>Pro Conical<br>Implant | Image: Implant | 3.3 | 2.4 | Narrow | 9 | 10.5 | 12 | 15 | 18 | | | Image: Implant | 3.8 | 2.8 | Narrow | 9 | 10.5 | 12 | 15 | 18 | | | Image: Implant | 4.2 | 3.0 | Regular | 9 | 10.5 | 12 | 15 | 18 | | | Image: Implant | 4.6 | 3.2 | Regular | 9 | 10.5 | 12 | 15 | 18 | | | Image: Implant | 5.2 | 4.3 | Regular | 9 | 10.5 | 12 | 15 | | | Tapered<br>Short<br>Conical<br>Implant | Image: Implant | 4.2 | 3.3 | Regular | 7.5 | | | | | | | Image: Implant | 4.6 | 3.7 | Regular | 7.5 | | | | | | | Image: Implant | 5.2 | 4.2 | Regular | 7.5 | | | | | # Summary of Subject Device Implant Designs and Sizes Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations. The Conical Ti-Base abutments are a two-piece abutment composed of a pre-manufactured Ti Base component and a CAD/CAM patient-matched mesostructure (superstructure) composed of sagemax® NexxZr zirconia (K130991). #### Tapered Pro Conical Healing Components, Abutments | • Cover Screws | • Multi-unit Abutments | |-----------------------|------------------------| | • Healing Caps | • Ti Base Abutments | | • SmartShape Healers | • Ti Blanks CAD/CAM | | • Temporary Abutments | | | • Esthetic Abutments | | # MATERIAL COMPOSITION The subject device implants, abutments and screws are manufactured from Ti-6Al-4 V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The threaded endosseous surface of the implant is blasted with resorbable blast media to create random, roughened texture that increases the implant surface area and helps achieve hard-tissue attachment with the implant at a cellular level. Laser-Lok treatment is applied to specified surface areas on the implants to create a non-random, roughened surface that is organized and oriented to achieve hard and soft tissue attachment. The Conical Ti Base abutments are composed of a pre-manufactured Ti Base component manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), and a superstructure manufactured from sagemax® NexxZr zirconia (K130991). Anodization is applied to certain implants and abutments to provide color for identification purposes. {7}------------------------------------------------ ### PERFORMANCE DATA Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: - . validation of gamma irradiation sterilization for subject devices provided sterile to the end user to a sterility assurance level of 106 by selecting and substantiating a 25 kGy dose using method VDmax>5, according to ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, leveraged from the primary predicate device K143022, BioHorizons Tapered Internal Implants, - bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing on samples from sterilized product to demonstrate all sterile product meets a limit of < 20 EU/device, leveraged from the reference device K203252, Multi-unit Abutments for CONELOG, - . validation of the recommended moist heat sterilization cycle for metallic components by the overkill method to a sterility assurance level (SAL) of 106 according to AAMI TIR30, Technical Information Report, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, and AAMI TIR12:2020, Technical Information Report, Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers, leveraged from the reference device K223697, MRI compatibility for existing BioHorizons dental implants and abutments, - . validation of the recommended moist heat sterilization method for Conical Ti Base abutments with zirconia superstructures cemented to them by the overkill method to a sterility assurance level (SAL) of 10 ° according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices, and ISO/TR 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1, - . shelf-life testing, including testing of samples after 5 years of real time aging according to ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration and F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials, leveraged from the primary predicate device K143022, BioHorizons Tapered Internal Implants, - biocompatibility testing of samples representing all subject device materials and manufacturing processes according to ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cvtotoxicity, and ISO 10993-12 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials, leveraged from the reference device K223697, MRI compatibility for existing BioHorizons dental implants and abutments, - . Magnetic Resonance Imaging (MRI) testing according to ASTM 2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, leveraged from the reference device K223697, MRI compatibility for existing BioHorizons dental implants and abutments, - mechanical testing according to ISO 14801 Dentistry - Implants - Dynamic loading test for endosseous dental implants, - . implant surface characterization was conducted utilizing Scanning Electron Microscopy (SEM)/Energy Dispersive Spectrometry (EDS) methodologies. No clinical data were included in this submission. {8}------------------------------------------------ ## EQUIVALENCE TO MARKETED DEVICES The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices. #### Substantial Equivalence of Indication for Use Statement (IFUS) The subject device implants and abutments are substantially equivalent in intended use to the primary predicate device cleared in K143022. The differences between the subject device Indications for Use Statement (IFUS) and that of the primary predicate device include, for the subject device, specific indications for BioHorizons Tapered Short Conical dental implants. Reference devices K172576 and K193401 also include specific indications for short implants. The subject device IFUS also addresses prosthetic components and the requirement that all digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture. Reference device K151621 includes prosthetic components and includes the requirement that all digitally designed abutments are to be sent to a BioHorizons validated milling center for manufacture. These minor differences do not impact substantial equivalence because all IFUS express equivalent intended use to facilitate functional and esthetic rehabilitation of the edentulous mandible or maxilla. ### Substantial Equivalence of Technological Characteristics All subject device implants, abutment screws are similar or identical in design, materials and technological characteristics to corresponding abutments of the primary predicate device K143022 or reference devices. The ranges of implant diameters and lengths are covered by the primary predicate device K143022 and reference devices K172576, K193401, K230108 and K071638. Subject device abutments are identical in design, except for anodization color and/or laser marking for identification purposes, to the abutments in K113779 and K193401. The subject device implant/abutment connection is identical to those of the reference devices K113779 and K193401, except that the implants of the reference devices have three cam features, while the subject device implant has six cam features. Subject device implants and selected prosthetic components are provided sterile. The dental implant sterile packaging system consists of a protective polystyrene vial with a screw-on high density polyethylene (HDPE) cap, the vial assembly placed in a thermoformed polyethylene terephthalate glycol (PETG) tray, and the tray sealed with a 1073B Tyvek® lid. Implant cover caps for two-stage surgical protocols are included in the cap of the vial. This packaging is identical to that of sterile implants cleared under K143022. For abutments provided sterile to the end-user, the packaging consists of 1073B Tyvek® and 48ga polyethylene terephthalate (PET)/2mil low density polyethylene (LDPE) pouches. This packaging is identical to that used for corresponding products cleared in K203252. For products provided non-sterile, packaging consists of 1073B Tyvek® and 48ga polyethylene terephthalate (PET)/2mil low density polyethylene (LDPE) pouches. This packaging is identical to that used for corresponding products cleared in K151621. {9}------------------------------------------------ Sterilization methods and the Sterility Assurance Level (10-9) are identical to those of products cleared under K143022. The risks associated with production of straight and angled patient-specific abutments from Conical Ti Blanks CAD/CAM in combination with the compatible implants are mitigated by mechanical testing in air. The risks associated with production of straight and angled superstructures for Conical Ti Base Abutments in combination with the compatible implants are mitigated by mechanical testing in saline. Overall, the subject device has the following similarities to the predicate devices: - has the same intended use, - . uses the same operating principle, - incorporates the same basic design, - . incorporates the same or very similar materials, and - . has similar packaging and is sterilized using the same materials and processes. The basis for the belief of BioHorizons Implant Systems Inc. that the subject device is substantially equivalent to the predicate devices is summarized in the following tables. {10}------------------------------------------------ | Subject Device | Indications for Use Statement | |------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Tapered Pro Conical Implant<br>System<br>BioHorizons Implant<br>Systems Inc. | BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible<br>or maxilla as an artificial root structure for single tooth replacement or for fixed<br>bridgework and dental retention. These dental implants may be restored immediately<br>(1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted<br>together for multiple tooth replacement or when stabilized with an overdenture<br>supported by multiple implants. | | | BioHorizons Tapered Short Conical dental implants are intended for use in the<br>mandible or maxilla as an artificial root structure for single tooth replacement or for<br>fixed bridgework and dental retention. These dental implants must be restored using<br>delayed loading, for single tooth replacement, or may be used with a terminal or<br>intermediate abutment for fixed or removable bridgework or for overdentures. Tapered<br>Short Conical implants should be used only when there is not enough space for a<br>longer implant. If the ratio of crown length to implant length is unfavorable, the<br>biomechanical risk factors have to be considered and appropriate measures have to be<br>taken by the dental professional. | | | BioHorizons conical dental prosthetic components connected to the endosseous dental<br>implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or<br>mandibular arch to provide support for prosthetic restorations. | | | All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti | # Table 1. Substantial Equivalence – Indications for Use Statement | Primary Predicate Device | Indications for Use Statement | |------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K143022<br>BioHorizons Tapered Internal<br>Implants<br><br>BioHorizons Implant<br>Systems Inc. | BioHorizons Tapered Internal Implants are intended for use in the mandible or maxilla<br>as an artificial root structure for single tooth replacement or for fixed bridgework and<br>dental retention. The implants may be restored immediately (1) with a temporary<br>prosthesis that is not in functional occlusion or (2) when splinted together for multiple<br>tooth replacement or when stabilized with an overdenture supported by multiple<br>implants. | | Reference Device | Indications for Use Statement | | K193401<br>Altatec GmbH<br>CAMLOG®/CONELOG®<br>PROGRESSIVE-LINE<br>Implants<br>Altatec GmbH | CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are intended for the<br>restoration of edentulous and partially edentulous jaws with prosthetic restorations<br>such as implant-supported single crowns, bridges and full dentures.<br>Specifically for:<br>• single-tooth gaps,<br>• partially edentulous jaws with several missing teeth or<br>• edentulous jaws.<br><br>CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are suitable for oral<br>endosseous implantation in the maxillary and/or mandibular bone and are intended for<br>immediate or delayed implantation. They are indicated for transgingival healing (one-<br>stage, using healing caps or abutments) or subgingival healing (two-stage, using cover<br>screws). If single phase healing is intended, the implants can be loaded immediately if<br>the primary stability achieved is adequate for functional loading. In conjunction with<br>the corresponding abutments, the implants can be used for screw-retained or cemented<br>restorations such as single crowns, bridges and full dentures.<br><br>CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants with a diameter of 3.3 mm<br>have the following additional specific indications:<br>Implants with a diameter of 3.3 mm are indicated as an alternative in cases where the<br>alveolar ridge width is only 5-6 mm. Because of their lower tensile strength compared<br>with larger diameter implants, they should only be used under the following<br>conditions:<br>• As single implants, they should be used only to replace mandibular incisors and/or<br>maxillary lateral incisors.<br>• An edentulous arch can only be restored with a bar retained superstructure with at<br>least four implants of 3.3 mm diameter without distal extensions.<br>• Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combined<br>with implants of larger diameter for splinted superstructures. However, the limited<br>strength of the implants with Ø 3.3 mm must be taken into account.<br>• Avoid excessive mechanical stressing of the implants when using ball abutments in<br>combination with Ø 3.3 mm<br>implants.<br>• The healing time for diameter 3.3 mm implants is at least 12 weeks.<br><br>CONELOG® implants with 7 mm length have the following additional specific<br>indications:<br>These Implants should only be used when there is not enough space for a longer<br>implant. Delayed loading in single tooth replacement is indicated with these implants.<br>If the ratio of crown length to implant length is unfavorable the biomechanical risk<br>factors have to be considered and appropriate measures have to be taken by the dental<br>professional. | | Reference Device | Indications for Use Statement | | K172576 | BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as<br>an artificial root structure for single tooth replacement or for fixed bridgework and | | Tapered Short Implants, | dental retention. The implants may be restored using delayed loading, or with a<br>terminal or intermediate abutment for fixed or removable bridgework, and for | | BioHorizons Implant<br>Systems Inc. LLC | overdentures. | {11}------------------------------------------------ {12}------------------------------------------------ | Reference Device | Indications for Use Statement | |------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K230108 | Straumann® dental implants are indicated for the functional and esthetic oral<br>rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. | | Straumann® BLC and TLC<br>Implants | They can be used for immediate, early or late implantation following the extraction or<br>loss of natural teeth. The implants can be placed with immediate function for single-<br>tooth and/or multiple-tooth restorations when good primary stability is achieved and | | Straumann USA, LLC | with appropriate occlusal loading to restore chewing function. | | Reference Device | Indications for Use Statement | | K071638<br>Tapered Internal Implant<br>System<br><br>BioHorizons Implant<br>Systems Inc. | The BioHorizons Tapered Internal Implant System is intended for use in the mandible<br>or maxilla for use as an artificial root structure for single tooth replacement or for<br>fixed bridgework and dental retention.<br><br>The BioHorizons Tapered Internal Implant System may be restored immediately<br>1) with a temporary prosthesis that is not in functional occlusion or<br>2) when splinted together for multiple tooth replacement or when stabilized<br>with an overdenture supported by multiple implants. | | Reference Device | Indications for Use Statement | | K151621 | BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant<br>to provide support for dental prosthetic restorations. The abutments include: 1) | | BioHorizons CAD/CAM<br>Abutments | Titanium abutment blanks with a pre-machined implant connection where the upper<br>portion may be custom-milled in accordance with a patient-specific design using<br>CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant<br>connection upon which a CAD/CAM designed superstructure may be fitted to | | BioHorizons Implant<br>Systems Inc. | complete a two-piece dental abutment. The abutments include an abutment screw for<br>fixation to the underlying implant. The abutments may be used for single-unit (single-<br>tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with<br>BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental<br>Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm<br>internal hex-connection mating platform diameters. | | | All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM<br>Abutments are intended to be sent to a BioHorizons-validated milling center for<br>manufacture. BioHorizons abutments designed using CAD/CAM techniques must<br>fulfill the BioHorizons allowable range of design parameters. | {13}------------------------------------------------ | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | |----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | | Tapered Pro Conical Implant<br>System | K143022 | K172576 | K193401 | K230108 | K071638 | | Feature | | BioHorizons Tapered<br>Internal Implants | Tapered Short Implants | Altatec GmbH<br>CAMLOG®/CONELOG®<br>PROGRESSIVE-LINE<br>Implants | Straumann® BLC and<br>TLC Implants | Tapered Internal Implant<br>System | | | BioHorizons Implant Systems<br>Inc. | BioHorizons Implant<br>Systems Inc. | BioHorizons Implant<br>Systems Inc. | Altatec GmbH | Straumann USA, LLC | BioHorizons Implant Systems<br>Inc. | | Reason for<br>Predicate/<br>Reference<br>Device | n/a | Indications for Use<br>Design of implants and<br>abutments, Materials | Short implants | Implant/abutment<br>connection,<br>4.2 x 7.5 implant | 3.3 x 18 implant | 5.2 diameter implants | | Implant<br>Placement | Bone Level | Bone Level | Bone Level | Bone Level | Bone Level, Tissue Level | Bone Level | | Implant Body<br>Shape | Tapered | Tapered | Tapered | Tapered | Tapered | Tapered | | External Thread<br>Design | Reverse Buttress threads with<br>apical cutting flutes | Reverse Buttress threads with<br>apical cutting flutes | Reverse Buttress threads<br>with apical cutting flutes | Reverse Buttress threads<br>with apical cutting flutes | Threads with apical cutting<br>flutes | Reverse Buttress threads with<br>apical cutting flutes | | Prosthetic<br>Interface<br>Connection | Deep conical with six anti-<br>rotation cams at the base of the<br>connection | Internal hex | Internal hex | Deep conical with three<br>anti-rotation cams at the<br>base of the connection | Conical | Internal hex | | Body Diameter<br>(mm) x<br>Length (mm),<br>Platform<br>Diameter (mm) | 3.3 x 9 - 18, 2.8 (Narrow)<br>3.8 x 9 - 18, 2.8 (Narrow)<br>4.2 x 7.5 - 18, 3.0 (Regular)<br>4.6 x 7.5 - 18, 3.0 (Regular)<br>5.2 x 7.5 - 15, 3.0 (Regular) | 3.4 x 9 - 18, 3.0 (Int. hex,<br>grey)<br>3.8 x 9 - 18, 3.5 (Int. hex,<br>yellow)<br>4.6 x 9 - 18, 4.5 (Int. hex,<br>green) | 4.6 x 6 - 7.5, 3.5 (Int. hex,<br>yellow)<br>5.8 x 6 - 7.5, 4.5 (Int. hex,<br>green) | 3.3 x 9 - 16, 2.8 (3.3, grey)<br>3.8 x 7 - 16, 3.0 (3.8,<br>yellow)<br>4.3 x 7 - 16, 3.0 (4.3, red)<br>5.0 x 7 - 16, 3.8 (5.0, blue) | For BLC<br>3.3 x 8 - 18, RB<br>3.75 x 6- 18, RB<br>4.5 x 6 - 18, WB<br>5.5 x 6 - 16, WB<br>6.5 x 6 - 14, WB | 3.8 x 9 - 15, 3.5 (Int. hex,<br>yellow)<br>4.6 x 7.5 - 15, 4.5 (Int. hex,<br>green)<br>5.8 x 7.5 - 15, 5.7 (Int. hex, blue) | | | Lengths = 7.5, 9, 10.5, 12, 15, 18 | Lengths = 9, 10.5, 12, 15, 18 | Lengths = 6, 7.5 | Lengths = 7, 9, 11, 13, 16 | Lengths = 6, 8, 10, 12, 14,<br>16, 18 | Lengths = 7.5, 9, 10.5, 12, 15 | | Implant Material | Ti-6Al-4V Alloy | Ti-6Al-4V Alloy | Ti-6Al-4V Alloy | CP Ti | Titanium-13 Zirconium<br>alloy | Ti-6Al-4V Alloy | | Implant<br>Endosseous<br>Surface | RBT (blasted with<br>hydroxyapatite) | RBT (blasted with<br>hydroxyapatite) | RBT (blasted with<br>hydroxyapatite) | Abrasive- blasted, acid<br>etched | SLA, SLActive | RBT (blasted with<br>hydroxyapatite), or HA | | Feature | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | | | Tapered Pro Conical Implant<br>System | K143022 | K172576 | K193401 | K230108 | K071638 | | | BioHorizons Implant Systems Inc. | BioHorizons Tapered<br>Internal Implants | Tapered Short Implants | Altatec GmbH<br>CAMLOG®/CONELOG®<br>PROGRESSIVE-LINE<br>Implants | Straumann® BLC and<br>TLC Implants | Tapered Internal Implant<br>System | | | | BioHorizons Implant<br>Systems Inc. | BioHorizons Implant<br>Systems Inc. | Altatec GmbH | Straumann USA, LLC | BioHorizons Implant Systems<br>Inc. | | Implant collar | Laser Lok, RBT | Laser Lok, RBT | Laser Lok, RBT | Machined, not machined | Machined | Laser Lok, Machined | | How Provided |…
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