(3 days)
Not Found
No
The 510(k) summary describes a purely mechanical dental implant system made of titanium alloy. There is no mention of software, algorithms, image processing, or any other components that would typically incorporate AI/ML.
Yes
The device is an implant used for denture stabilization, which is a therapeutic intervention.
No
The device description indicates it is a dental implant system used for denture stabilization, which is a therapeutic rather than diagnostic function.
No
The device description explicitly details a physical, machined titanium implant and associated surgical components, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "denture stabilization using multiple implants in the anterior mandible and maxilla." This is a surgical procedure involving the placement of a physical device within the body.
- Device Description: The device is described as a "machined titanium, screw-form implant." It is a physical implant designed to be surgically placed.
- 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 in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The BioHorizons Maximus OS overdenture system implant may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.
The BioHorizons Maximus OS Implant may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The BioHorizons Maximus OS overdenture system dental implant is a machined titanium, screw-form implant supplied in lengths of 12mm, 15mm and 18mm and tissue collar heights of 2mm and 4mm, available with each length. 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 device is further processed by roughening the surface with tricalcium phosphate blast media 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 106, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.
The Maximus OS dental implant is a comprehensive system containing implants and surgical components, with the implants configured specifically for use in denture stabilization: reference the Intended Use section following.
All BioHorizons implants referenced in this submission are 3.0mm in diameter with D3 thread form and surface treatment using tricalcium phosphate blast media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
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.)
Not Found
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
JUL 2 2 2004
510(k) Summary 21 CFR 807.92
Date: Official Contact: Manufacturer:
July 12, 2004 Winston Greer, Director, QA & RA BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 Phone: (205) 967-7880 Fax: (205) 870-0304
Proprietary Name
The Maximus™ OS (Overdenture System) Implant
Common Name
Screw-type Dental Implant
Classification Name
Endosseous implants, surgical components, and prosthetic attachments
Predicate Devices
Predicate devices are:
-
- The BioHorizons 3.0mm diameter implant, a screw-type endosseous implant manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) number K032351, concurrence date October 21, 2003.
-
- The BioHorizons O-ring Abutment, an endosseous implant abutment for direct attachment of tissue supported overdentures manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant system has been documented under 510(k) number K023067, concurrence date April 9, 1999.
Device Description
The BioHorizons Maximus OS overdenture system dental implant is a machined titanium, screw-form implant supplied in lengths of 12mm, 15mm and 18mm and tissue collar heights of 2mm and 4mm, available with each length. 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 device is further processed by roughening the surface with tricalcium phosphate blast media 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 106, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.
1
The Maximus OS dental implant is a comprehensive system containing implants and surgical components, with the implants configured specifically for use in denture stabilization: reference the Intended Use section following.
All BioHorizons implants referenced in this submission are 3.0mm in diameter with D3 thread form and surface treatment using tricalcium phosphate blast media. The following table provides a summary of the proposed catalog item or reference numbers by implant length and collar height.
| Catalog
REF
Number | Length
(mm) | Collar
Height
(mm) |
|--------------------------|----------------|--------------------------|
| 3012OS2 | 12 | 2 |
| 3012OS4 | | 4 |
| 3015OS2 | 15 | 2 |
| 3015OS4 | | 4 |
| 3018OS2 | 18 | 2 |
| 3018OS4 | | 4 |
Intended Use
The BioHorizons Maximus OS overdenture system implant may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.
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 Maximus 3.0mm diameter endosseous implant and O-Ring Abutment devices. The BioHorizons Maximus OS overdenture system implants are substantially equivalent to all features of the predicate devices 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 logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent coiled around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 2004
Mr. Winston D. Greer Director, QA & RA BioHorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230, South Birmingham, Alabama 35243
Re: K041938
Trade/Device Name: Maximus OS (Overdenture System) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: July 12, 2004 Received: July 19, 2004
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.
3
Page 2 - Mr. 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 (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 vour 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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours.
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
BioHorizons Implant Systems, Inc. The Maximus™ OS Special 510(k): Device Modification July 12, 2004
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Device Name: BioHorizons Maximus™ OS Overdenture System Implant
Indications for Use:
The BioHorizons Maximus OS Implant may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runno
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K041938
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use