(79 days)
Not Found
No
The document describes a physical dental implant made of titanium and its mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention, which is a therapeutic function to restore oral function and aesthetics.
No
The device description clearly states its purpose as an "artificial root structure" for tooth replacement and retention, and its composition as "machined titanium, screw-form endosseous dental implants." This aligns with a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states the device is a machined titanium, screw-form endosseous dental implant, which is a physical hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, 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 replacement and retention, to be implanted in the mandible or maxilla. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics, material, and processing of a dental implant. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device is designed to be surgically placed within the body.
Therefore, the BioHorizons Tapered Internal Implants are a medical device, specifically a dental implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BioHorizons Tapered Internal 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
Tapered Internal Implants are machined titanium, screw-form endosseous The BioHorizons dental implants supplied in 3.4mm and 4.6mm diameters. The 3.4mm diameter implant includes lengths of 9mm, 10.5mm, 15mm and 18mm while the 3.8mm and 4.6mm diameter implants include an 18mm length option to complement currently cleared implant lengths within those implant body 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 (tricalcium phosphate) and by micro-machining grooves, known as Laser• The product is packaged using Lok® microchannels, to the implant collar of select models. 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 ANSVAAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part I: 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
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the 3.0mm implant-abutment connection (as featured in the subject devices) was performed in accordance with the Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004 and ISO 14801. The load-bearing features of the implant-abutment connection were tested in conjunction with angled prosthetic abutments representative of the worst-case scenario. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8,2015
BioHorizons Implant Systems, Inc. Michael Davis Regulatory Affairs Manager 2300 Riverchase Center Birmingham, AL 35244
Re: K143022
Trade/Device Name: BioHorizons Tapered Internal Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 9, 2014 Received: December 10, 2014
Dear Mr. 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. 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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Page 2 - Mr. Davis
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number: K143022
Device Name: BioHorizons Tapered Internal Implants
Indications for Use:
BioHorizons Tapered Internal 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
K143022
S10(k) Summary 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, Regulatory Affairs Manager |
| Date prepared: December 2, 2014 |
Name of the Device
| Trade Name: | BioHorizons Tapered Internal Implants |
|---|---|
| Common or Usual Name: | Screw-type dental implant |
| Classification Name: | Endosseous dental implant |
| Classification Number: | Class II (21 CFR 872.3640) |
Predicate Devices
-
- BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10,2007.
- BioHorizons Laser-Lok 3.0 Implant System, documented under 510(k) number K093321, 2. concurrence date of April 2, 2010.
Device Description
Tapered Internal Implants are machined titanium, screw-form endosseous The BioHorizons dental implants supplied in 3.4mm and 4.6mm diameters. The 3.4mm diameter implant includes lengths of 9mm, 10.5mm, 15mm and 18mm while the 3.8mm and 4.6mm diameter implants include an 18mm length option to complement currently cleared implant lengths within those implant body 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 (tricalcium phosphate) and by micro-machining grooves, known as Laser• The product is packaged using Lok® microchannels, to the implant collar of select models. 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 ANSVAAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.
Intended Use
BioHorizons Tapered Internal 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 Internal endosseous dental implant devices subject to this 510(k) is substantially equivalent to the referenced predicate The threaded portion of the implants is RET-blasted, and Laser-Lok microchannels are devices. applied to the implant collar of select models.
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.
All materials, suppliers, processing, packaging and sterilization methods remain the same as for the predicate BioHorizons Tapered Internal Implant System (K071638) and BioHorizons Laser® Lok 3.0 Implant System (K093321). The Laser-Lok feature is substantially equivalent to that cleared for the predicate devices. The BioHorizons Tapered Internal Implants are substantially equivalent to the features of the predicate implant devices which could affect safety or effectiveness because of the similarities in design, materials and intended use. Refer to Table 1, Summary Table of Substantial Equivalence, immediately following on the next page.
Summary of Testing
Mechanical testing of the 3.0mm implant-abutment connection (as featured in the subject devices) was performed in accordance with the Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004 and ISO 14801. The load-bearing features of the implant-abutment connection were tested in conjunction with angled prosthetic abutments representative of the worst-case scenario. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.
Conclusion
The data presented in this submission demonstrates that the new devices are substantially equivalent with respect to performance, safety and effectiveness for their intended use and perform as well as the referenced predicate device.
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| Subject Device | Predicate Devices | ||
|---|---|---|---|
| BioHorizons Implant Systems, Inc. | BioHorizons Implant Systems, Inc. | BioHorizons Implant Systems, Inc. | |
| !Modified! Tapered Internal Implants | Tapered Internal Implant System K071638 | Laser-Lok 3.0 Implant System K093321 | |
| Intended Use | Biol-lorizons Tapered Internal 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. | |||
| Biol-Iorizons Tapered Internal Implants may be | |||
| restored immediately | |||
| I) 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. | Biol-lorizons Tapered Internal Implant System 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.
Biol-lorizons Tapered Internal Implant System may
be restored immediately
I) 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. | Biol-lorizons Laser-Lok 3.0 Implants may be
used as an artificial root structure for single
tooth replacement of mandibular central and
lateral incisors and maxillary lateral incisors.
The implants may be restored immediately
I) with a temporary prosthesis that is not in
functional occlusion, - when splinted together as an artificial root
structure for multiple tooth replacement of
mandibular incisors, or - for denture stabilization using multiple
implants in the anterior mandible and
maxilla.
The implants may be placed in immediate
function when good primary stability has been
achieved and with appropriate occlusal loading. |
| Design | | | |
| Implant shape | Tapered | Tapered | Parallel-wall with 2.5mm apical taper |
| Implant body
diameter | 3.4mm, 3.8mm, 4.6mm | 3.8mm, 4.6mm, 5.8mm | 3.0mm |
| Implant length | 9mm, 10.5mm, 12mm, 15mm, 18mm | 7.5mm (except 3.8mm body), 9mm, 10.5mm,
12mm、15mm | 10.5mm, 12mm, 15mm |
| Outer thread | External Buttress | External Buttress | Square |
| Surface | Implant- RBT
Collar- Laser-Lok or RBT | Implant- RBT or HA
Collar- Laser-Lok | Implant - RBT
Collar- Laser-Lok |
| Hex connection | Internal | Internal | Internal |
| Internal thread | Spiralock UNF 1-72 | Spiralock UNF 1-72 | Spiralock UNF 1-72 |
| Prosthetic
platform | 3.0mm, 3.5mm, 4.5mm | 3.5mm, 4.5mm, 5.7mm | 3.0mm |
| Material and Manufacturing | | | |
| Implant Material | Ti-6Al-4V (ASTM F136) | Ti-6AI-4V (ASTM Fl36) | Ti-6Al-4V (ASTM F136) |
| Manufacturing
process | Machined by BioHorizons or A-level
supplier, surface treated with micro-
machined grooves (Laser-Lok) and RBT or
RBTonly | Machined by BioHorizons or A-level supplier,
surface treated with micro-machined grooves
(Laser-Lok) and RBT or HA | Machined by BioHorizons or A-level
supplier, surface treated with micro-
machined grooves (Laser-Lok) and RBT |
| Packaging | Tyvek-lidded blister tray (primary
package), placed inside a tamper-evident
outer box (secondary package) | Tyvek-lidded blister tray | Tyvek-lidded blister tray |
| Sterilization | 25-40 kGy gamma irradiation dose range | 20-40 kGy gamma irradiation dose range | 20-40 kGy gamma irradiation dose range |