(133 days)
No
The summary describes a physical dental implant and abutment system and its mechanical and biological properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is a dental implant system intended for use as an artificial root structure for single tooth replacement or for fixed bridgework, which clearly indicates its purpose in treating and restoring bodily function.
No
Explanation: The device is described as an endosseous dental implant and abutment system intended for use as an artificial root structure for single tooth replacement or fixed bridgework. Its purpose is to provide support for prosthetic restorations, not to diagnose medical conditions or diseases.
No
The device description clearly states it is an endosseous dental implant and abutment system, which are physical hardware components. The submission also includes extensive non-clinical data related to the physical properties and performance of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an artificial root structure for dental implants and prosthetic components used in the mouth (mandible or maxilla). This is a surgical and restorative device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics of the dental implants and abutments, their materials, and how they are used in a surgical and prosthetic context. There is no mention of analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Detecting specific analytes (e.g., proteins, DNA, antibodies).
- Providing diagnostic information about a disease or condition.
- Using reagents or calibrators.
The device is a medical device used for surgical implantation and dental restoration.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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.
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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.
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.
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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)
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) | |
|---|---|
| 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 Center
Birmingham, AL 35244
Telephone +1 205-967-7880 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Jared Cooper, Ph.D., Director, Regulatory Affairs |
| Representative/Consultant | Floyd G. Larson, MS, MBA
Kevin A. Thomas, PhD
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1 858-792-1235
Fax: +1 858-792-1236
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, |
| 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.
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.
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| Implant Line | Image
Not to
Scale | Body Ø, mm | Apical Ø, mm | Prosthetic Platform | Length, mm | | | | |
|----------------------------------------|--------------------------|------------|--------------|---------------------|------------|------|----|----|----|
| Tapered
Pro Conical
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
Short
Conical
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