(161 days)
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No
The document describes a physical dental implant and its materials and testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a dental implant used as an artificial root structure for teeth, which is a structural replacement rather than a therapeutic intervention.
No
The provided text describes a dental implant, which is a prosthetic device used to replace missing teeth. It does not mention any diagnostic capabilities, such as measuring or detecting medical conditions.
No
The device description clearly states the device is a "machined titanium, screw-form endosseous dental implant" and describes its physical characteristics and materials, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "artificial root structure for single tooth replacement" and for "denture stabilization." This is a surgical implant intended to be placed directly into the human body.
- Device Description: The description details the physical characteristics of a dental implant (machined titanium, screw-form, surface treatments) and its components (abutments, restorative components). These are all physical devices for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is clearly intended for implantation within the body.
N/A
Intended Use / Indications for Use
BioHorizons 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
-
- 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.
Product codes
DZE, NHA
Device Description
BioHorizons Laser-Lok 3.0 Implants are machined titanium, screw-form endosseous dental implants supplied in 3.0mm diameter across lengths of 10.5mm. 12mm and Implant material is titanium alloy as specified in ASTM F136 Standard 15mm. 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 application of patterns of micro-machined grooves or channels, known as Laser-Lok®, 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/SO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
The BioHorizons Laser-Lok 3.0 Implant System includes a series of implant abutments, as well as the usual and customary restorative components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
mandibular central and lateral incisors and maxillary lateral incisors, anterior mandible and 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)
fatigue testing demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the BioHorizons Laser-Lok 3.0 Implant System and the referenced predicate devices. Fatigue testing also demonstrated that the BioHorizons Laser-Lok 3.0 Implant System meets its predefined acceptance criteria and performs in accordance with its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080396, K073268, K052419, K071638
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
510(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 Specialist |
| Date prepared: | March 31, 2010 |
Name of the Device
| Trade Name: | BioHorizons Laser-Lok 3.0 Implant System |
|---|---|
| Common or Usual Name: | Screw-type dental implant |
| Classification Name: | Endosseous dental implant |
| Classification Number: | Class II (21 CFR 872.3640) |
Predicate Devices
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- Astra Tech AB OsseoSpeed™ Narrow, documented under 510(k) number K080396, concurrence date of April 30, 2008.
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- BioHorizons Internal Implant System, documented under 510(k) number K073268, concurrence date of February 8, 2008.
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- BioHorizons One-piece 3.0 Implant System, documented under 510(k) number K052419, concurrence date of September 20, 2005.
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- BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10, 2007.
Device Description
BioHorizons Laser-Lok 3.0 Implants are machined titanium, screw-form endosseous dental implants supplied in 3.0mm diameter across lengths of 10.5mm. 12mm and Implant material is titanium alloy as specified in ASTM F136 Standard 15mm. 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 application of patterns of micro-machined grooves or channels, known as Laser-Lok®, 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/SO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
The BioHorizons Laser-Lok 3.0 Implant System includes a series of implant abutments, as well as the usual and customary restorative components.
APR - 2 2010
1
Intended Use
BioHorizons 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
-
- 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.
Technological Characteristics
The fundamental scientific technology of the BioHorizons Laser-Lok 3.0 Implant System of endosseous dental implant devices subject to this 510(k) is substantially equivalent to the referenced predicate devices. The indication for use for conditional immediate restoration is substantially equivalent to the predicate BioHorizons Internal Implant System (K073268), and immediate restoration is an accepted and prevalent clinical practice of demonstrated safety and efficacy. The threaded portion of the implants is RBT-blasted, and Laser-Lok is 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 (unlike Sharpey fiber attachment). This tissue connection:
-
- is functionally oriented,
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- inhibits epithelial cell downgrowth and
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- 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 Internal Implant System (K073268), and the Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Internal Implant System. The BioHorizons Laser-Lok 3.0 Implant System, which is the subject of this 510(k), is 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
Among the information and data presented in this 510(k) submission to support the substantial equivalence of the BioHorizons Laser-Lok 3.0 Implant System to the specified predicate devices, fatigue testing demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the BioHorizons Laser-Lok 3.0 Implant System and the referenced predicate devices. Fatigue testing also demonstrated that the BioHorizons Laser-Lok 3.0 Implant System meets its predefined acceptance criteria and performs in accordance with its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 2 2010
Mr. Michael Davis Regulatory Affairs Specialist BioHorizons Implant Systems. Incorporated 2300 Riverchase Center Birmingham, Alabama 35244
Re: K093321
Trade/Device Name: BioHorizons Laser-Lok 3.0 Implant System Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 31, 2010 Received: April 1, 2010
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,
Anthony D. Owen
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: K093321
Device Name: BioHorizons Laser-Lok 3.0 Implant System
Indications for Use:
BioHorizons 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
-
- 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.
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)
Cimaton h. R.P
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: