(139 days)
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No
The summary describes a physical dental implant made of titanium and its intended use. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is an artificial root structure for tooth replacement, which restores a physical function rather than treating a disease.
No
The device description indicates it is a physical implant used as an artificial root structure for tooth replacement or as abutments. It does not perform any diagnostic function.
No
The device description explicitly states the device is "machined titanium, root-form implants" and details the material (titanium alloy) and physical dimensions. This indicates a hardware device, not software.
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 applications (single tooth replacement, fixed bridgework, denture retention). 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 of the implant (material, dimensions, packaging, sterilization). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of diagnostic information being provided.
Therefore, the BioHorizons BioLok Micro-Lok endosseous implant is a medical device, specifically a dental implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the BioHorizons BioLok Micro-Lok endosseous implants is in the mandible and maxilla as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
The BioLok Micro-Lok Implant System may be used in edentulous sites for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
Product codes
DZE
Device Description
The BioHorizons BioLok Micro-Lok dental implants are machined titanium, root-form implants supplied in 3.45mm, 3.75mm, 4mm, and 4.75mm diameters across lengths of 8mm, 10mm, 11,5mm, 13mm, and 15mm. Implant and accessory surgical component raw material is titanium alloy as specified in ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
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 to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandible and maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
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: | June 25, 2008 |
NOV 1 3 2008
Name of the Device
| Trade Name: | BioLok Micro-Lok Implant System |
|---|---|
| Common or Usual Name: | Screw-type Dental Implants |
| Classification Name: | Endosseous implants, surgical components, and prosthetic |
| attachments | |
| Classification Number: | Class II |
Predicate Device
The Minimatic (BioLok International) Various Implant Systems, documented under 510(k) number K952905, concurrence date of April 16, 1997.
Device Description
The BioHorizons BioLok Micro-Lok dental implants are machined titanium, root-form implants supplied in 3.45mm, 3.75mm, 4mm, and 4.75mm diameters across lengths of 8mm, 10mm, 11,5mm, 13mm, and 15mm. Implant and accessory surgical component raw material is titanium alloy as specified in ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
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 to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.
Intended Use
The intended use of the BioHorizons BioLok Micro-Lok endosseous implants is in the mandible and maxilla as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
Technological Characteristics
The fundamental scientific technology of the device is identical to the referenced predicate device. All materials and specifications (with the exception of the particular ASTM standard titanium specified in the original 510(k) submission), processing and sterilization methods remain the same as for the predicate Minimatic endosseous implants. The material has not changed to a type that has not been used in other legally marketed devices within the same classification regulation for the same intended use. The BioHorizons BioLok Micro-Lok implants are substantially equivalent to all features of the predicate Minimatic (BioLok International) Various Implant System device which could affect safety or effectiveness because of the similarities in design, material and intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2008
Mr. Michael Davis Regulatory Affairs Specialist BioHorizons Implant Systems, Incorporated 2300 Riverchase Center Birmingham, Alabama 35244
Re: K081818
Trade/Device Name: BioLok Micro-Lok Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 10, 2008 Received: October 14, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suditte Y. Michau Omd.
EDR DR. CHILL UN Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: _ KO81818
Device Name: BioLok Micro-Lok Implant System
Indications for Use:
The BioLok Micro-Lok Implant System may be used in edentulous sites for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (per 21 CFR 801.109) | |
|---|---|
| OR | Over-the-Counter Use |
| (Division Sign-Off) | Super Rover |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | Raf18f |