(70 days)
No
The device description and performance studies focus on the physical properties, materials, and mechanical testing of a dental implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: While the device replaces an anatomical structure and aids in its function, it explicitly states it is an "artificial root structure" for replacing missing teeth, which is a restorative rather than therapeutic function.
No
Explanation: The device is described as an artificial root structure for tooth replacement, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a machined titanium, screw-form endosseous dental implant, which is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an "artificial root structure for single tooth replacement or for fixed bridgework and dental retention." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description details a "machined titanium, screw-form endosseous dental implant." This is consistent with a surgical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a physical implant placed within the body.
N/A
Intended Use / Indications for Use
BioHorizons Tapered IM 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. The 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The BioHorizons Tapered IM Implants are machined titanium, screw-form endosseous dental implants supplied in 7.0mm and 8.0mm diameters. Both implants include a 5.7mm prosthetic platform. The implants are provided in 7.5mm, 9.0mm and 10.5mm lengths across both diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (hydroxylapatite) and by micro-machining grooves, known as Laser-Loke microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10-6, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
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)
A comparative dimensional assessment was performed comparing the worst-case subject Tapered IM implant device (smallest implant body diameter combined with the shortest implant length) to the worst-case predicate Tapered Internal Plus implant device and Tapered Internal implant device (smallest prosthetic platform/smallest implant body diameter combined with the shortest implant length). The intent of the assessment was to develop objective evidence that the Tapered IM implant is substantially equivalent to the Tapered Internal Plus implant and the Tapered Internal implant as it relates to design and mechanical strength. Acceptance criteria dictated that the Tapered IM implant connection geometry, in relation to the implant external profile, shall have equal or greater (>=) wall thickness compared to the Tapered Internal Plus implant and the Tapered Internal implant. In addition to the dimensional assessment, a retrospective review of mechanical testing for the predicate Tapered Internal Plus implant and Tapered Internal Implant was also performed. Dynamic mechanical fatigue testing was performed in accordance with ISO 14801, Dentistry - Implants - Dynamic Fatigue Test for Endosseous Dental Implants for the worst-case 3.8mm x 15mm Tapered Internal Plus implant assembled with a 3.0mm Angled Esthetic Abutment and the worst-case 3.8mm x 15mm Tapered Internal implant assembled with a 3.5mm Angled Custom Abutment. The implant-abutment assemblies survived three consecutive fatigue runouts for 5 million cycles. The predicate device fatigue testing was included in the applicable 510(k). The aforementioned comparative dimensional assessment combined with the successful fatigue testing of the worst-case predicate device qualify the Tapered Internal IM implants for their intended use.
Sterilization validation was evaluated in accordance with ANSI/AAMI/ISO 11137-1. Validation parameters were established for this device and are substantially equivalent to those used in the primary predicate device cleared under K121787.
Endotoxin testing is routinely performed in accordance with ANSI/AAMI ST72. Testing consistently demonstrates that endotoxin levels do not exceed the acceptance limit of 20.0 EU per device per USP .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K103691, K151621, K071638, K071161
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 10, 2018
BioHorizons Implant Systems, Inc. Michael Davis Director, Regulatory Affairs 2300 Riverchase Center Birmingham, Alabama 35244
Re: K182070
Trade/Device Name: BioHorizons Tapered IM Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 7, 2018 Received: September 11, 2018
Dear Michael Davis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Indications for Use | Food and Drug Administration | | 510(K) Number (if known)
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| See PRA Statement below | isquration Date: 06/30/2020 | | | | | | | |
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tooth replacement or for fixed bridgework and dental retention.
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3
510(k) Summarv 21 CFR 807.92
Submitter's Name & Address
| Manufacturer: | BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham, AL 35244
Phone (205) 967-7880
Fax (205) 870-0304 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Official contact: | Michael Davis, Director, Regulatory Affairs |
| Date prepared: | October 10, 2018 |
Name of the Device
| Trade Name: | BioHorizons Tapered IM Implants |
|---|---|
| Common or Usual Name: | Screw-type dental implant |
| Classification Name: | Endosseous dental implant |
| Classification Number: | Class II (21 CFR 872.3640) |
Predicate Devices
Primary Predicate Device:
-
- K121787, BioHorizons Tapered Internal Plus Implants, September 5, 2012.
Reference Predicate Devices:
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- K103691, BioHorizons Abutments for Zimmer, November 3, 2011.
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- K151621, BioHorizons CAD/CAM Abutments, January 13, 2016.
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- K071638. BioHorizons Tapered Internal Implant System, October 10, 2017.
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- K071161, Endosseous Dental Implant System, November 16, 2007.
Device Description
The BioHorizons Tapered IM Implants are machined titanium, screw-form endosseous dental implants supplied in 7.0mm and 8.0mm diameters. Both implants include a 5.7mm prosthetic The implants are provided in 7.5mm, 9.0mm and 10.5mm lengths across both platform. diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surqical Implant Applications.
The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (hydroxylapatite) and by micro-machining grooves, known as Laser-Loke microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Indications for Use
BioHorizons Tapered IM 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. The 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.
4
Technological Characteristics
The fundamental scientific technology of the BioHorizons Tapered IM endosseous dental implant devices subject to this 510(k) is substantially equivalent to the primary predicate device. The threaded portion of the implants is RBT-blasted, and Laser-Lok microchannels are applied to the implant collar.
Laser-Lok is a surface feature in which patterns of micro-machined grooves are applied to the collar of a dental implant, providing a roughened surface to establish a physical, connective tissue attachment. This tissue connection:
-
- is functionally oriented,
-
- inhibits epithelial cell downgrowth, and
-
- enables crestal bone adjacent to the implant to attach and be retained
The preceding claims are supported in the published literature by Nevins et al. Human Histologic Evidence of a Connective Tissue Attachment to a Dental Implant, International Journal of Periodontics & Restorative Dentistry 2008; 28:111-121 and Ricci et al. Bone Response to Laser Microtextured Surfaces, Bone Engineering 2000:382-392.
All materials, suppliers, processing, packaging and sterilization methods remain the same as for the primary predicate device, BioHorizons Tapered Internal Plus Implants (K121787). The Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Tapered Internal Plus Implants. The BioHorizons Tapered IM Implants are substantially equivalent to the features of the predicate implant devices because of the similarities in design, materials and intended use. Refer to Table 1, Summary Table of Substantial Equivalence, immediately following.
Summary of Testing
A comparative dimensional assessment was performed comparing the worst-case subject Tapered IM implant device (smallest implant body diameter combined with the shortest implant length) to the worst-case predicate Tapered Internal Plus implant device and Tapered Internal implant device (smallest prosthetic platform/smallest implant body diameter combined with the shortest implant length). The intent of the assessment was to develop objective evidence that the Tapered IM implant is substantially equivalent to the Tapered Internal Plus implant and the Tapered Internal implant as it relates to design and mechanical strength. Acceptance criteria dictated that the Tapered IM implant connection geometry, in relation to the implant external profile, shall have equal or greater (≥) wall thickness compared to the Tapered Internal Plus implant and the Tapered Internal implant. In addition to the dimensional assessment, a retrospective review of mechanical testing for the predicate Tapered Internal Plus implant and Tapered Internal Implant was also performed. Dynamic mechanical fatigue testing was performed in accordance with ISO 14801, Dentistry - Implants - Dynamic Fatigue Test for Endosseous Dental Implants for the worst-case 3.8mm x 15mm Tapered Internal Plus implant assembled with a 3.0mm Angled Esthetic Abutment and the worst-case 3.8mm x 15mm Tapered Internal implant assembled with a 3.5mm Angled Custom Abutment. The implant-abutment assemblies survived three consecutive fatigue runouts for 5 million cycles. The predicate device fatigue testing was included in the applicable 510(k). The aforementioned comparative dimensional assessment combined with the successful fatigue testing of the worst-case predicate device qualify the Tapered Internal IM implants for their intended use.
Sterilization validation was evaluated in accordance with ANSI/AAMI/ISO 11137-1. Validation parameters were established for this device and are substantially equivalent to those used in the primary predicate device cleared under K121787.
Endotoxin testing is routinely performed in accordance with ANSI/AAMI ST72. Testing consistently demonstrates that endotoxin levels do not exceed the acceptance limit of 20.0 EU per device per USP .
5
Additional data relied on from BioHorizons previous dental implant device submissions to demonstrate substantial equivalence to the predicate devices includes evaluation of the RBT surface treatment process as is applied to all BioHorizons dental implant devices. The surface and processing used in this device are substantially equivalent to those used in the reference predicate device cleared under K071638.
Finally, BioHorizons Tapered IM Implants meet the chemical requirements of ASTM F136. This grade of Titanium is commonly used in surgical implant applications thus no special biocompatibility testing was conducted for the proposed devices. The material and processing used in this device are substantially equivalent to those used in the reference predicate device cleared under K071638.
Conclusion
The data presented in this submission demonstrates that the proposed device is substantially equivalent to the primary predicate devices with respect to performance and intended use. Any risks associated with differences noted in the Indications for Use of the proposed device and predicate devices have been mitigated by additional information included in the Warnings and Precautions section of the Instructions for Use. The additional information includes limiting use of the proposed device to the molar region, providing placement recommendations, and adding clinician considerations for use of these devices.
The proposed device performs as well as the legally marketed predicate devices. Furthermore. the proposed device does not pose any new or increased risks as compared to the legally marketed predicate devices.
6
Table 1. Summary Table of Substantial Equivalence
| Subject Device | Primary Predicate Device | Reference Predicate Devices | |||||
|---|---|---|---|---|---|---|---|
| BioHorizons Implant | |||||||
| Systems, Inc. | |||||||
| Tapered IM Implants | BioHorizons Implant | ||||||
| Systems, Inc. | |||||||
| Tapered Internal Plus | |||||||
| Implants | BioHorizons Implant Systems, | ||||||
| Inc. Abutments for Zimmer | |||||||
| K103691 | BioHorizons Implant Systems, | ||||||
| Inc. | |||||||
| CAD/CAM Abutments | |||||||
| K151621 | BioHorizons Implant Systems, | ||||||
| Inc. | |||||||
| Tapered Internal Implant | |||||||
| Systems | |||||||
| K071638 | Southern Implant - | ||||||
| Endosseous Dental | |||||||
| Implant System | |||||||
| K071161 | |||||||
| Intended Use | BioHorizons Tapered IM | ||||||
| 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 | |||||||
| retention. |
BioHorizons Tapered IM
Implants may be restored
immediately
- with a temporary prosthesis
that is not in functional
occlusion, or - when splinted together for
multiple tooth replacement,
or when stabilized with an
overdenture supported by
multiple implants. | BioHorizons Tapered Internal
Plus 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
retention.
BioHorizons Tapered Internal
Plus Implants may be restored
immediately
- with a temporary prosthesis
that is not in functional
occlusion, or - when splinted together for
multiple tooth replacement,
or when stabilized with an
overdenture supported by
multiple implants. | BioHorizons Abutments for
Zimmer® are abutments that
include healing abutments for
contouring tissue and final
restorative abutments to support
a prosthesis. The abutments
may be used for a single or
multiple unit restoration and are
compatible for use with
BioHorizons Internal and Tapered
Internal implant systems and
Zimmer® Dental Screw-Vent® and
Tapered Screw-Vent® implants
with 3.5mm, 4.5mm and 5.7mm
internal hex-connection mating
platform diameters.
BioHorizons Titanium Base
Abutments and Laser-Lok
Titanium Base Abutments are
intended to be used to be used
as straight abutments. | CAD/CAM
Abutments are dental abutments
placed onto a dental implant to
provide support for dental
prosthetic restorations. The
abutments include: 1) Titanium
abutment blanks with a pre-
machined implant connection
where the upper portion may be
custom-milled in accordance with
a patient-specific design using
CAD/CAM techniques; and 2)
Titanium bases with a pre-
machined implant connection
upon which a CAD/CAM designed
superstructure may be fitted to
complete a two-piece dental
abutment. The abutments include
an abutment screw for fixation 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 with BioHorizons Internal
and Tapered Internal implant
systems and Zimmer® Dental
Screw-Vent® and Tapered
Screw-Vent® implants with
3.5mm, 4.5mm and 5.7mm
internal hex-connection mating
platform diameters.
All digitally designed abutments
and/or copings for use with
BioHorizons CAD/CAM
Abutments are intended to be
sent to a BioHorizons-validated
milling center for manufacture.
BioHorizons abutments designed
using CAD/CAM techniques must
fulfill the BioHorizons allowable
range of design parameters. | BioHorizons Tapered Internal
Implant Systems is 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
retention.
BioHorizons Tapered Internal
Implants may be restored
immediately
- with a temporary prosthesis that
is not in functional occlusion, or - when splinted together for
multiple tooth replacement or
when stabilized with an
overdenture supported by multiple
implants. | The NSI MAX Implant
System is intended for
implantation in the
maxillary or mandibular
molar region where bone
exists and the surgeon has
determined that the
placement of a narrower
diameter implant would
increase the probability of
failure due to poor primary
stability, or increased
surgical procedures
leading to complications.
This MAX implant provides
support for fixed or
removable dental
prostheses in a single
tooth, partially endentulous
prostheses, or full arch
prostheses. It further adds
the option for immediate
loading on single and
splinted multiple unit
restorations when good
primary stability is
achieved and with
appropriate occlusal
loading, to restore chewing
function. | |
| Design | | | | | | | |
| Implant shape | Tapered | Tapered | N/A | N/A | Tapered | Tapered | |
| Implant body diameter | 7.0mm, 8.0mm | 3.8mm, 4.6mm, 5.8mm | N/A | N/A | 3.8mm, 4.6mm, 5.8mm | 7mm, 8mm and 9mm
diameter | |
| Implant length | 7.5mm, 9.0mm, 10.5mm | 7.5mm (except 3.8mm body),
9mm, 10.5mm, 12mm, 15mm | N/A | N/A | 7.5mm, 9.0mm, 10.5mm, 12.0mm.
15mm | 7.0mm, 9.0mm, 11.0mm | |
| Outer thread | Buttress | Buttress | N/A | N/A | Reverse Buttress | V-thread | |
| Surface | Implant - RBT
Collar - Laser-Lok | Implant - RBT
Collar - Laser-Lok | Anodize, TiN coating, Laser-Lok | Anodize, TiN coating, Laser-Lok | Implant - RBT, HA
Collar - Laser-Lok or Machined | Machined collar and
blasted body | |
| Connection | Internal Hex | Internal Hex | Internal Hex | Internal Hex | Internal Hex | External hex, Tri-Nex, IT
(internal connection) | |
| Internal thread | Spiralock UNF 1-72 | Spiralock UNF 1-72 | N/A | N/A | Spiralock UNF 1-72 | V-thread - size unknown | |
| Prosthetic platform | 5.7mm | 3.0mm, 3.5mm, 4.5mm | 3.5mm, 4.5mm, 5.7mm | 3.0mm, 3.5mm, 4.5mm, 5.7mm | 3.5mm, 4.5mm, 5.7mm | External hex: 5.0mm,
6.0mm, 7.0mm
Tri-Nex: 5.0mm, 6.0mm
IT (internal connection):
4.8mm, 6.5mm | |
| Material and Manufacturing | | | | | | | |
| Implant Material | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Ti-6AI-4V (ASTM F136) | Ti-6Al-4V (ASTM F136) | Titanium - grade unknown | |
| Manufacturing process | Machined by BioHorizons or A-
level supplier, surface treated
with micro-machined grooves
(Laser-Lok) and RBT | Machined by BioHorizons or A-
level supplier, surface treated
with micro-machined grooves
(Laser-Lok) and RBT | Machined by BioHorizons or A-
level supplier, select models are
surface treated with micro-
machined grooves (Laser-Lok),
TiN coating and anodized on the
hex connection | Machined by BioHorizons or A-
level supplier, select models are
surface treated with micro-
machined grooves (Laser-Lok),
TiN coating and anodized on the
hex connection (except 3.0mm
hex) | Machined by BioHorizons or A-
level supplier, surface treated with
micro-machined grooves (Laser-
Lok) and RBT | Unknown | |
| Packaging | Tyvek-lidded blister tray
(primary package), placed
inside a tamper-evident outer
box (secondary package) | Tyvek-lidded blister tray
(primary package), placed
inside a tamper-evident outer
box (secondary package) | Poly/Tyvek pouch | Poly/Tyvek pouch | Tyvek-lidded blister tray | Unknown | |
| Sterilization | 25-40 kGy gamma irradiation
dose range | 25-40 kGy gamma irradiation
dose range | N/A; abutments provided non-
sterile for moist heat sterilization | N/A; abutments provided non-
sterile for moist heat sterilization | 25-40 kGy gamma irradiation dose
range | Unknown | |
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