(22 days)
Not Found
No
The 510(k) summary describes a physical dental implant made of titanium alloy with surface treatments. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
Yes
The device is described as an artificial root structure for tooth replacement and abutments for fixed bridgework and denture retention, indicating it is used to treat or alleviate a medical condition related to tooth loss.
No
Explanation: The device description clearly states it is a dental implant, an artificial root structure for replacement, fixed bridgework, and denture retention. It replaces missing parts of the body, rather than diagnosing conditions.
No
The device description clearly states the device is a machined titanium, screw-form implant, which is a physical hardware component, not software.
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.
- Device Description: The BioHorizons Single-stage endosseous implants are physical implants designed to be surgically placed inside the body (in the mandible and maxilla) to function as artificial tooth roots.
- Intended Use: The intended use is to provide structural support for dental prosthetics, not to analyze biological samples.
The information provided clearly describes a surgically implanted medical device, not a device used for laboratory testing of biological specimens.
N/A
Intended Use / Indications for Use
The intended use of BioHorizons Single-stage 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 BioHorizons Single-stage implant may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The BioHorizons Single-stage dental implants are machined titanium, screw-form implants supplied in 3.5mm, 4mm, 5mm, 6mm diameters across lengths of 7mm, 9mm, 10.5mm 12mm and 15mm. Implant raw material is titanium alloy as specified in ASTM F 136, 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 Fi 185, 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 11/10T - n 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
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)
Not Found
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).
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
BioHorizons Implant Systems, Inc. BioHorizons Single-stage Implants Special 510(k) Notification November 8, 2005 DEC 2
K053/52
2005
510(k) Summary 21 CFR 807.92
Submitter's Name & Address
| Manufacturer: | BioHorizons Implant Systems, Inc.
One Perimeter Park South
Suite 230 South
Birmingham, AL 35243
Phone: (205) 967-7880
Fax: (205) 870-0304 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official contact:
Date prepared: | Winston Greer, Vice-President, QA & RA
October 25, 2005 |
Name of the Device
| Trade Name: | BioHorizons Single-stage Implant |
|---|---|
| Common or Usual Name: | Screw-type Dental Implant |
| Classification Name: | Endosseous implants, surgical components, and prosthetic |
| attachments | |
| Classification Number: | Class II |
Predicate Devices
-
- The Maestro System extended collar implants, documented under 510(k) number K020645, concurrence date of March 15, 2002.
-
- The Prodigy System internal-connection implants, documented under 510(k) number K042429, concurrence date of September 16, 2005.
Device Description
The BioHorizons Single-stage dental implants are machined titanium, screw-form implants supplied in 3.5mm, 4mm, 5mm, 6mm diameters across lengths of 7mm, 9mm, 10.5mm 12mm and 15mm. Implant raw material is titanium alloy as specified in ASTM F 136, 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 Fi 185, 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 11/10T - n 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 BioHorizons Single-stage 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.
1
BioHorizons Implant Systems, Inc. BioHorizons Single-stage Implants Special 510(k) Notification November 8, 2005
K053/52
Technological Characteristics
The fundamental scientific technology of the device is identical to the referenced predicate devices. All materials, suppliers, processing, packaging and sterilization methods remain the same as for the predicate BioHorizons Single-stage endosseous implants. The BioHorizons Single-stage implants are substantially equivalent to all features of the predicate Maestro System and Prodigy System device which could affect safety or effectiveness because of the similarities in design, material and intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three wavy lines extending from its body.
Public Health Service
DEC 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Winston Greer Vice President, Quality Assurance & Regulatory Affairs Biohorizons Implants Systems, Incorporated One Perimeter Park South Suite 230, South Birmingham, Alabama 35243
Re: K053152
Trade/Device Name: BioHorizons Single-Stage Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: November 8, 2005 Received: November 10, 2005
Dear Mr. 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 – Mr. Lichtenwalner
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 and instille (s 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 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 vours,
Chiu-Ling, 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
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Page 1 of 1
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: BioHorizons Single-stage Implant
Indications for Use:
The BioHorizons Single-stage implant may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-the-Counter Use |
|---|---|---|---|
| (per 21 CFR 801.109) |
| Sign-Off |
|---|
| Division of Anesthesiology, General Hospital, |
| Section Control, Dental Devices |
| Member Number: | K053152 |
|---|---|
| ---------------- | --------- |