(80 days)
Not Found
No
The 510(k) summary describes a standard dental implant made of titanium alloy with surface treatments. There is no mention of software, algorithms, or any technology related to AI or ML. The description focuses on the material, dimensions, surface treatments, and sterilization of the physical implant device.
No.
The device is described as an "artificial root structure" for replacing teeth, which functions as a structural support rather than a device for treating or curing a disease or condition. While it aids in restoring dental function, its primary role is prosthetic.
No
The device is described as an artificial root structure for tooth replacement, a physical implant, not a tool for diagnosis.
No
The device description explicitly states the device 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a dental implant, which is a device surgically implanted into the body (in vivo) to replace a tooth root. Its purpose is structural support for dental prosthetics, not diagnostic testing of bodily specimens.
The description focuses on the physical characteristics, materials, and surgical application of the implant, which are typical of an implantable medical device, not an IVD.
N/A
Intended Use / Indications for Use
BioHorizons 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.
BioHorizons 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
BioHorizons Internal Implants are machined titanium, screw-form endosseous dental implants supplied in 3.5mm, 4.0mm, 6.0mm, 6.0mm diameters across lengths of 9mm, 5mm, 12mm and 15mm. 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 surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite For Surgical Implants, to promote implant fixation. 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 to 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.
The BioHorizons Internal Implant System includes a series of implant catalog item numbers with Laser-Lok® technology applied to the implant collar to provide additional treatment options for the dental implant clinician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
maxilla, mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental implant clinician
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): 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.
Not Found
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
n(k) Premarket Notification
BioHorizons Internal Implant System
Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically "K073268". The characters are bold and appear to be handwritten or stylized. The sequence consists of an uppercase letter 'K', followed by the number '0', then '73268'.
510(k) Summary 21 CFR 807.92
ibmitter's Name & Address
| Manufacturer: | BioHorizons Implant Systems, Inc. |
|---|---|
| 2300 Riverchase Center | |
| Birmingham, AL 35244 | |
| Phone (205) 967-7880 | |
| Fax (205) 870-0304 | |
| Official contact: | |
| Date prepared: | Winston Greer, Vice-President, QA & RA |
| November 19, 2007 |
rED -8 4000
ame of the Device
| Trade Name: | BioHorizons Internal 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
| BioHorizons Internal Implant System (formerly "The Prodigy System Dental · Implants"), documented under 510(k) number K042429, concurrence date of September 16, 2004.
- BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10, 2007.
Device Description
BioHorizons Internal Implants are machined titanium, screw-form endosseous dental polants supplied in 3.5mm, 4.0mm, 6.0mm, 6.0mm diameters across lengths of 9mm. ( 5mm, 12mm and 15mm. Implant material is titanium alloy as specified in ASTM 196 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra ow Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
te devices are further processed by roughening the surface with tricalcium phosphate ast media, or by applying hydroxylapatite coating conforming to ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical miniants, to promote implant fixation. The product is packaged using materials known i the industry to be appropriate for medical device packaging and is provided with a ammum sterility assurance level of 10 €, validated in compliance to ANSI / AAMI / ISO 1137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for evelopment, validation and routine control of a sterilization process for medical evices.
the BioHorizons Internal Implant System includes a series of implant catalog item umbers with Laser-Lok® technology applied to the implant collar to provide additional reatment options for the dental implant clinician.
1
ntended Use
intended ประ
BioHorizons Internal Implants are intended for use in the maxilla as an a BioHorizons internal implants are intended for use in the fixed bridgework and dental retention.
BioHorizons Internal Implants may be restored immediately
- BioHonzons intornal insplants that is not in functional occlusion, or
-
- when splinted together for multiple tooth replacement, or when stabilized with an
- when opture supported by multiple implants.
Technological Characteristics
The fundamental scientific technology of the BioHorizons Internal Implant System of endosseous dental implant devices subject to this 510(k) is substantially or vivalent to the referenced predicate devices. The addition to the indications for use for conditional immediate restoration is substantially equivalent to the nredicate BioHorizons Tapered Internal Implant System (K071638), and immediate restoration is an accepted and prevalent clinical practice of demonstrated safety and efficacy. Laser-Lok is a surface feature in which patterns of micro-machined grooves are applied to the collar surface of a dental mplant to (1) inhibit epithelial cell downgrowth around the implant, and (2) attach and retain crestal bone adjacent to the implant. All materials, suppliers, processing, packaging and sterilization methods remain the same as for the predicate BioHorizons Prodigy (K042429) and Tapered Internal endosseous mplants, and the Laser-Lok feature is substantially equivalent as that cleared for the Tapered Internal Implant System. The BioHorizons Internal Implant System which is the subject of this 510(k) is substantially equivalent to all features of the predicate BioHorizons Prodigy and Tapered Internal implant devices which could affect safety or effectiveness because of the similarities in design, materials and ntended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's three main goals: health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB -8 2008
Dr. Winston Greer Vice President, Quality Assurance & Regulatory Affairs BioHorizons Implant Systems, Incorporated 2300 Riverchase Center Birmingham, Alabama 35244
Re: K073268
Trade/Device Name: BioHorizons Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 19, 2007 Received: November 20, 2007
Dear Dr. Greer:
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.
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Page 2 - Dr. Greer
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 (OS) 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chis Lisz, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1 of 1
k) Number:
ice Name: BioHorizons Internal Implant System
ndications for Use:
gioHorizons Internal Implants are intended for use in the mandible or maxilla as an adficial root structure for single tooth replacement or for fixed bridgework and dental efention.
oHorizons 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073268
rescription Use per 21 CFR 801.109) OR
Over-the-Counter Use