(79 days)
Not Found
No
The 510(k) summary describes a physical dental implant made of titanium alloy with specific surface treatments. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies focus on mechanical properties and insertion torque, not algorithmic performance.
Yes
Explanation: The device is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention, which aligns with the definition of a therapeutic device.
No
The device is an artificial root structure for single tooth replacement or for fixed bridgework and dental retention, not a device used to diagnose a medical condition.
No
The device description clearly states it is a machined titanium, screw-form endosseous dental implant, which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a dental implant, which is a physical device surgically placed into the jawbone to support a dental prosthesis. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Intended Use: The intended use clearly states it's for use in the mandible or maxilla as an artificial root structure for tooth replacement. This is a structural and functional replacement, not a diagnostic test.
The description focuses on the physical characteristics, materials, manufacturing process, and mechanical performance of the implant, all of which are typical for a medical device intended for surgical implantation, not for an IVD.
N/A
Intended Use / Indications for Use
BioHorizons Tapered Internal Plus 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
DZE
Device Description
BioHorizons Tapered Internal Plus Implants are machined titanium, screw-form endosseous dental implants supplied in 3.8mm, 4.6mm and 5.8mm diameters across lengths of 7.5mm (except 3.8mm diameter), 9mm, 12mm and 15mm. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov (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-Lok® microchannels, to 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.
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)
Mechanical testing was performed on the subject devices 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 devices were tested in conjunction with both straight and angled prosthetic abutments. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.
Insertion torque testing performed on the subject devices demonstrates that the 3.0mm implant level driver can fully seat the 3.8mm Tapered Internal Plus implants in all bone densities without loss of function of the implant hex or the driver hex with an average insertion torque of 214.4 Nom.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
average insertion torque of 214.4 Nom.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 5 2012
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, Regulatory Affairs Manager |
| Date prepared: | August 3, 2012 |
Name of the Device
| Trade Name: | BioHorizons Tapered Internal Plus Implants |
|---|---|
| Common or Usual Name: | Screw-type dental implant |
| Classification Name: | Endosseous dental implant |
| Classification Number: | Class II (21 CFR 872.3640) |
Predicate Device
-
- BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10, 2007.
Device Description
BioHorizons Tapered Internal Plus Implants are machined titanium, screw-form endosseous dental implants supplied in 3.8mm, 4.6mm and 5.8mm diameters across lengths of 7.5mm (except 3.8mm diameter), 9mm, 12mm and 15mm. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov (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-Lok® microchannels, to 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.
Intended Use
BioHorizons Tapered Internal Plus 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.
1
Technological Characteristics
The fundamental scientific technology of the BioHorizons Tapered Internal Plus endosseous dental implant devices subject to this 510(k) is substantially equivalent to the referenced 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.
All materials, suppliers, processing, packaging and sterilization methods remain the same as for the predicate BioHorizons Tapered Internal Implant System (K071638), and the Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Tapered Internal Implant System. The BioHorizons Tapered Internal Plus 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.
Summary of Testing
Mechanical testing was performed on the subject devices 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 devices were tested in conjunction with both straight and angled prosthetic abutments. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.
Insertion torque testing performed on the subject devices demonstrates that the 3.0mm implant level driver can fully seat the 3.8mm Tapered Internal Plus implants in all bone densities without loss of function of the implant hex or the driver hex with an average insertion torque of 214.4 Nom.
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.
2
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BioHorizons Implant Systems, Incorporated Mr. Michael Davis Regulatory Affairs Manager 2300 Riverchase Center Birmingham, Alabama 35244
SEP 5 2012
Re: K121787
Trade/Device Name: BioHorizons Tapered Internal Plus Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 3, 2012 Received: August 6, 2012
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.
3
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
. 510(k) Number: K120787
Device Name: BioHorizons Tapered Internal Plus Implants
Indications for Use:
BioHorizons Tapered Internal Plus 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)
Susan Rosser
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anestheolorology.
Infection Control, Dental Devices
Infection Control #:
510(k) Number: K121787