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.

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.

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).

AI/ML Overview

The provided text is a 510(k) premarket notification summary for a dental implant system. It does not describe a study to prove the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it contain information on the performance data, sample sizes, expert ground truth establishment, or multi-reader multi-case studies typically associated with such devices.

The document focuses on demonstrating substantial equivalence to predicate dental implants and their components. The "PERFORMANCE DATA" section (page 7 of the PDF, starting on page 8 of the transcription) lists non-clinical data such as validation of sterilization, bacterial endotoxin testing, shelf-life testing, biocompatibility, MRI compatibility, and mechanical testing, which are standard for dental implants.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML medical device.

To be explicit, the document states:

"No clinical data were included in this submission." (Page 7)
The performance data discussed are entirely non-clinical and relate to the physical and material properties of the dental implants, not an AI or software component assessing images or providing diagnostic assistance.

Summary

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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.

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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.

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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) K240187

Device Name

Tapered Pro Conical Implant System

Indications for Use (Describe)

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary BioHorizons Implant Systems Inc. Tapered Pro Conical Implant System

June 5, 2024

ADMINISTRATIVE INFORMATION

Manufacturer Name	BioHorizons Implant Systems Inc.2300 Riverchase CenterBirmingham, AL 35244Telephone +1 205-967-7880
Official Contact	Jared Cooper, Ph.D., Director, Regulatory Affairs
Representative/Consultant	Floyd G. Larson, MS, MBAKevin A. Thomas, PhDPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 858-792-1235Fax: +1 858-792-1236Email: 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,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.

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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.

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

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Implant Line	ImageNot toScale	Body Ø, mm	Apical Ø, mm	Prosthetic Platform	Length, mm
TaperedPro ConicalImplant	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
TaperedShortConicalImplant	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

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.

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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.

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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.

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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.

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Subject Device	Indications for Use Statement
Tapered Pro Conical ImplantSystemBioHorizons ImplantSystems Inc.	BioHorizons Tapered Pro Conical dental implants are intended for use in the mandibleor maxilla as an artificial root structure for single tooth replacement or for fixedbridgework and dental retention. These dental implants may be restored immediately(1) with a temporary prosthesis that is not in functional occlusion or (2) when splintedtogether for multiple tooth replacement or when stabilized with an overdenturesupported by multiple implants.
	BioHorizons Tapered Short Conical dental implants are intended for use in themandible or maxilla as an artificial root structure for single tooth replacement or forfixed bridgework and dental retention. These dental implants must be restored usingdelayed loading, for single tooth replacement, or may be used with a terminal orintermediate abutment for fixed or removable bridgework or for overdentures. TaperedShort Conical implants should be used only when there is not enough space for alonger implant. If the ratio of crown length to implant length is unfavorable, thebiomechanical risk factors have to be considered and appropriate measures have to betaken by the dental professional.
	BioHorizons conical dental prosthetic components connected to the endosseous dentalimplants are intended for use as an aid in prosthetic rehabilitations of the maxillary ormandibular 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
K143022BioHorizons Tapered InternalImplantsBioHorizons ImplantSystems Inc.	BioHorizons Tapered Internal Implants are intended for use in the mandible or maxillaas an artificial root structure for single tooth replacement or for fixed bridgework anddental retention. The implants may be restored immediately (1) with a temporaryprosthesis that is not in functional occlusion or (2) when splinted together for multipletooth replacement or when stabilized with an overdenture supported by multipleimplants.
Reference Device	Indications for Use Statement
K193401Altatec GmbHCAMLOG®/CONELOG®PROGRESSIVE-LINEImplantsAltatec GmbH	CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are intended for therestoration of edentulous and partially edentulous jaws with prosthetic restorationssuch as implant-supported single crowns, bridges and full dentures.Specifically for:• single-tooth gaps,• partially edentulous jaws with several missing teeth or• edentulous jaws.CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are suitable for oralendosseous implantation in the maxillary and/or mandibular bone and are intended forimmediate or delayed implantation. They are indicated for transgingival healing (one-stage, using healing caps or abutments) or subgingival healing (two-stage, using coverscrews). If single phase healing is intended, the implants can be loaded immediately ifthe primary stability achieved is adequate for functional loading. In conjunction withthe corresponding abutments, the implants can be used for screw-retained or cementedrestorations such as single crowns, bridges and full dentures.CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants with a diameter of 3.3 mmhave the following additional specific indications:Implants with a diameter of 3.3 mm are indicated as an alternative in cases where thealveolar ridge width is only 5-6 mm. Because of their lower tensile strength comparedwith larger diameter implants, they should only be used under the followingconditions:• As single implants, they should be used only to replace mandibular incisors and/ormaxillary lateral incisors.• An edentulous arch can only be restored with a bar retained superstructure with atleast four implants of 3.3 mm diameter without distal extensions.• Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combinedwith implants of larger diameter for splinted superstructures. However, the limitedstrength of the implants with Ø 3.3 mm must be taken into account.• Avoid excessive mechanical stressing of the implants when using ball abutments incombination with Ø 3.3 mmimplants.• The healing time for diameter 3.3 mm implants is at least 12 weeks.CONELOG® implants with 7 mm length have the following additional specificindications:These Implants should only be used when there is not enough space for a longerimplant. Delayed loading in single tooth replacement is indicated with these implants.If the ratio of crown length to implant length is unfavorable the biomechanical riskfactors have to be considered and appropriate measures have to be taken by the dentalprofessional.
Reference Device	Indications for Use Statement
K172576	BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla asan 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 aterminal or intermediate abutment for fixed or removable bridgework, and for
BioHorizons ImplantSystems Inc. LLC	overdentures.

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Reference Device	Indications for Use Statement
K230108	Straumann® dental implants are indicated for the functional and esthetic oralrehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.
Straumann® BLC and TLCImplants	They can be used for immediate, early or late implantation following the extraction orloss of natural teeth. The implants can be placed with immediate function for single-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
K071638Tapered Internal ImplantSystemBioHorizons ImplantSystems Inc.	The BioHorizons Tapered Internal Implant System is intended for use in the mandibleor maxilla for use as an artificial root structure for single tooth replacement or forfixed bridgework and dental retention.The BioHorizons Tapered Internal Implant System may be restored immediately1) with a temporary prosthesis that is not in functional occlusion or2) when splinted together for multiple tooth replacement or when stabilizedwith an overdenture supported by multiple implants.
Reference Device	Indications for Use Statement
K151621	BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implantto provide support for dental prosthetic restorations. The abutments include: 1)
BioHorizons CAD/CAMAbutments	Titanium abutment blanks with a pre-machined implant connection where the upperportion may be custom-milled in accordance with a patient-specific design usingCAD/CAM techniques; and 2) Titanium bases with a pre-machined implantconnection upon which a CAD/CAM designed superstructure may be fitted to
BioHorizons ImplantSystems Inc.	complete a two-piece dental abutment. The abutments include an abutment screw forfixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use withBioHorizons Internal and Tapered Internal implant systems and Zimmer® DentalScrew-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mminternal hex-connection mating platform diameters.
	All digitally designed abutments and/or copings for use with BioHorizons CAD/CAMAbutments are intended to be sent to a BioHorizons-validated milling center formanufacture. BioHorizons abutments designed using CAD/CAM techniques mustfulfill the BioHorizons allowable range of design parameters.

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	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device	Reference Device
	Tapered Pro Conical ImplantSystem	K143022	K172576	K193401	K230108	K071638
Feature		BioHorizons TaperedInternal Implants	Tapered Short Implants	Altatec GmbHCAMLOG®/CONELOG®PROGRESSIVE-LINEImplants	Straumann® BLC andTLC Implants	Tapered Internal ImplantSystem
	BioHorizons Implant SystemsInc.	BioHorizons ImplantSystems Inc.	BioHorizons ImplantSystems Inc.	Altatec GmbH	Straumann USA, LLC	BioHorizons Implant SystemsInc.
Reason forPredicate/ReferenceDevice	n/a	Indications for UseDesign of implants andabutments, Materials	Short implants	Implant/abutmentconnection,4.2 x 7.5 implant	3.3 x 18 implant	5.2 diameter implants
ImplantPlacement	Bone Level	Bone Level	Bone Level	Bone Level	Bone Level, Tissue Level	Bone Level
Implant BodyShape	Tapered	Tapered	Tapered	Tapered	Tapered	Tapered
External ThreadDesign	Reverse Buttress threads withapical cutting flutes	Reverse Buttress threads withapical cutting flutes	Reverse Buttress threadswith apical cutting flutes	Reverse Buttress threadswith apical cutting flutes	Threads with apical cuttingflutes	Reverse Buttress threads withapical cutting flutes
ProstheticInterfaceConnection	Deep conical with six anti-rotation cams at the base of theconnection	Internal hex	Internal hex	Deep conical with threeanti-rotation cams at thebase of the connection	Conical	Internal hex
Body Diameter(mm) xLength (mm),PlatformDiameter (mm)	3.3 x 9 - 18, 2.8 (Narrow)3.8 x 9 - 18, 2.8 (Narrow)4.2 x 7.5 - 18, 3.0 (Regular)4.6 x 7.5 - 18, 3.0 (Regular)5.2 x 7.5 - 15, 3.0 (Regular)	3.4 x 9 - 18, 3.0 (Int. hex,grey)3.8 x 9 - 18, 3.5 (Int. hex,yellow)4.6 x 9 - 18, 4.5 (Int. hex,green)	4.6 x 6 - 7.5, 3.5 (Int. hex,yellow)5.8 x 6 - 7.5, 4.5 (Int. hex,green)	3.3 x 9 - 16, 2.8 (3.3, grey)3.8 x 7 - 16, 3.0 (3.8,yellow)4.3 x 7 - 16, 3.0 (4.3, red)5.0 x 7 - 16, 3.8 (5.0, blue)	For BLC3.3 x 8 - 18, RB3.75 x 6- 18, RB4.5 x 6 - 18, WB5.5 x 6 - 16, WB6.5 x 6 - 14, WB	3.8 x 9 - 15, 3.5 (Int. hex,yellow)4.6 x 7.5 - 15, 4.5 (Int. hex,green)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, 14,16, 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 Zirconiumalloy	Ti-6Al-4V Alloy
ImplantEndosseousSurface	RBT (blasted withhydroxyapatite)	RBT (blasted withhydroxyapatite)	RBT (blasted withhydroxyapatite)	Abrasive- blasted, acidetched	SLA, SLActive	RBT (blasted withhydroxyapatite), or HA
Feature	Subject Device	Primary Predicate Device	Reference Device	Reference Device	Reference Device	Reference Device
	Tapered Pro Conical ImplantSystem	K143022	K172576	K193401	K230108	K071638
	BioHorizons Implant Systems Inc.	BioHorizons TaperedInternal Implants	Tapered Short Implants	Altatec GmbHCAMLOG®/CONELOG®PROGRESSIVE-LINEImplants	Straumann® BLC andTLC Implants	Tapered Internal ImplantSystem
		BioHorizons ImplantSystems Inc.	BioHorizons ImplantSystems Inc.	Altatec GmbH	Straumann USA, LLC	BioHorizons Implant SystemsInc.
Implant collar	Laser Lok, RBT	Laser Lok, RBT	Laser Lok, RBT	Machined, not machined	Machined	Laser Lok, Machined
How Provided
Sterility	Sterile	Sterile	Sterile	Sterile	Sterile	Sterile

Table 2. Substantial Equivalence – Technological Characteristics – Implants

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{15}------------------------------------------------

Cover Screws
	Subject Device	Reference Device
Feature	Tapered Pro Conical-Implant SystemBioHorizons ImplantSystems Inc.	K113779CONELOG ImplantSystemAltatec GmbH
Coronal Ø, mm	3.3, 3.8	3.3, 3.8
Connection	Conical, non-engaging	Conical, non-engaging
Material	Ti-6Al-4V Alloy	Ti-6Al-4V Alloy
Surfacetreatment	Anodized, None	Anodized, None
How Provided
Sterility	Sterile	Sterile
Usage	Single patient, single-use	Single patient, single-use

Table 3. Substantial Equivalence – Technological Characteristics – Prosthetic Components

	Healing Caps
--	--------------

Healing Caps
	Subject Device	Reference Device
		K113779
Feature	Tapered Pro Conical-Implant System	CONELOG Implant System
		Altatec GmbH
	BioHorizons Implant Systems Inc.
Gingival Ø, mm	3.3 – 5.8	3.3, 5.8
Gingival Height, mm	2.0, 4.0, 6.0	2.0, 4.0, 6.0
Connection	Conical, non-engaging	Conical, non-engaging
Material	Ti-6Al-4V Alloy	Ti-6Al-4V Alloy
Surface treatment	Anodized, None	Anodized, None
How Provided
Sterility	Sterile	Sterile
Usage	Single patient, single-use	Single patient, single-use

{16}------------------------------------------------

	Subject Device	Reference Device
		K113779
Feature	Tapered Pro Conical-ImplantSystemBioHorizons Implant Systems Inc.	CONELOG Implant SystemAltatec GmbH
Gingival Height, mm	1.5, 2.0, 3.0	1.5, 2.0, 3.0
Angulation	0°, 15°, 20°	0°, 15°, 20°
Connection	Conical, engaging	Conical, engaging
Material	Ti-6Al-4V Alloy	Ti-6Al-4V Alloy
Surface treatment	Anodized, None	Anodized, None
How Provided
Sterility	Non-sterile	Non-sterile
Usage	Single patient, single-use	Single patient, single-use

Conical Esthetic Abutments

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Feature	Subject Device	Reference DeviceK203252
	Tapered Pro Conical-ImplantSystem	Multi-unit Abutments forCONELOG
	BioHorizons Implant Systems Inc.	BioHorizons Implant Systems Inc.
Prosthetic Platform Ø, mm	4.8	4.8
Gingival Height, mm	2, 3, 4	2, 3, 4
Angulation	0°, 17°, 30°	0°, 17°, 30°
Connection	Conical, engaging, non-engaging	Conical, engaging, non-engaging
Material	Ti-6Al-4V Alloy	Ti-6Al-4V Alloy
How Provided
Sterility	Sterile	Sterile
Usage	Single patient, single-use	Single patient, single-use

Conical Multi-unit Abutments

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Conical Ti Base Abutments

	Subject Device	Reference Device
		K151621
Feature	Tapered Pro Conical-Implant SystemBioHorizons Implant Systems Inc.	BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems Inc.
Stock Gingival Height, mm	0.8, 2.0	1.0
Angulation	up to 20°	up to 20°
Connection	Engaging, Non-engaging	Engaging, Non-engaging
Material	Ti-6Al-4V Alloy	Ti-6Al-4V Alloy
Surface Treatment	Anodized, None	Anodized, None
Superstructure	sagemax® NexxZr zirconia (K130991) bonded using3M™ RelyX™ Unicem 2 Automix Self-AdhesiveResin Cement (K022476) or similar	Metoxit Z-CAD dental ceramic (K072569) (or equivalent) bondedusing RelyX Unicem (K022476) (or equivalent)
Design Limitations	• 20° maximum post angulation.• 0.4mm minimum wall thickness.• 5mm maximum superstructure gingival margin height.• Abutments with a superstructure post height less than 4.0mm are intended for multi-unit restorations only• Screw channel: 25° maximum angled screw channel for 0.8mm margin height, 15° maximum angled screw channel for 2.0mm margin height.(Minimum gingival margin height is established by the gingival height of the stock Ti Base Abutment.)NOTE: The post-height of the abutment is measured above the total gingival margin height of the final patient-matched design.	Feature Minimum Size Wall thickness 0.4mm Gingival margin diameter 5.1mm Length of the abutment post 3.9mm Taper Variable based on anatomy Feature maximum sizes are based on patient anatomy and clinician discretion.
How Provided
SterilityUsage	Non-sterileSingle patient, single use	Non-sterileSingle patient, single use

{19}------------------------------------------------

Conical Ti Blank CAD/CAM

	Subject Device	Reference Device
Feature	Tapered Pro Conical-Implant SystemBioHorizons Implant Systems Inc.	K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems Inc.
Angulation	up to 30°	up to 30°
Connection	Engaging	Engaging
Material	Ti-6Al-4V Alloy	Ti-6Al-4V Alloy
Surface Treatment	Anodized, None	Anodized, None
Design Limitations	30° maximum post angulation. 0.6mm minimum wall thickness. 0.5mm minimum gingival margin height (from implant-abutment junction). Minimum height above the screw head is 0.2mm Abutments with a post height less than 4.0 mm are intended for multi-unit restorations only. NOTE: The post-height of the abutment is measured above the total gingival margin height of the final patient-matched design.	Feature Ø3.0mm Ø3.5mm, Ø4.5mm, Ø5.7mm Min Max Min Max Wall thickness 0.5mm 3.8mm 0.3mm 3.6mm Gingival margin diameter 3.0mm 9.7mm 3.0mm 9.7mm Gingival margin height 0mm 12.1mm 0mm 12.1mm Length of the abutment post * 12.1mm * 12.1mm Taper of the abutment 0° 90° 0° 90° Angulation 0° 30° 0° 30° *Minimum allowable abutment post dimensions are 3.0mm for screw retained abutment and 4.0mm for cement retained abutment.
	How Provided
Sterility	Non-sterile	Non-sterile
Usage	Single patient, single-use	Single patient, single-use

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.