(83 days)
No
The summary describes a physical dental implant and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is described as an artificial root structure for tooth replacement and denture stabilization, which are therapeutic interventions.
No
The device is a dental implant system used as an artificial root structure for tooth replacement and denture stabilization. It does not perform any diagnostic function.
No
The device description clearly states it is a "machined titanium, screw-form implant" and a "comprehensive system containing implants and surgical components," indicating it is a physical medical device, not software-only.
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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The BioHorizons Maestro System 3.0 mm Diameter Implant is a dental implant designed to be surgically placed into the jawbone as an artificial root structure. It is a physical device implanted into the body, not used to test samples taken from the body.
The description clearly outlines its use in replacing teeth and stabilizing dentures, which are surgical and prosthetic procedures, not in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The BioHorizons 3.0mm diameter implant mav be used:
- (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
- (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function.
- (3) 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
DZE
Device Description
The BioHorizons Maestro System 3.0mm diameter dental implant is a machined titanium, screw-form implant supplied in lengths of 12mm, 15mm and 18mm. 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 treating the surface with resorbable blast media (RBM). 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, Sterlization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.
The Maestro System™ 3.0mm Diameter Implant is a comprehensive system containing implants and surgical components. The BioHorizons 3.0mm diameter implant may be used: (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion; (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function; (3) 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.
All BioHorizons implants referenced in this submission are 3.0mm in diameter with D3 thread form and surface treated using resorbable blast media (hydroxylapatite conforming to ASTM F 1185, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants). The following table provides a summary of the proposed implant catalog item or reference numbers by length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular central and lateral incisors and maxillary lateral incisors, mandibular 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
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)
K960026, K964330, K972313, K010458, K020133, K020645, K022795, K030463
Reference Device(s)
K992512, K972351, K990983, K023067
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
OCT 2 1 2003
BioHorizons Implant Systems, Inc.
The Maestro System™ 3.0mm Diameter Implant 510(k) Notification, July 25, 2003 - revised October 16, 2003
510(k) summary
| 21 CFR 807.92 | |
|---|---|
| Date: | July 25, 2003 |
| Official Contact: | Winston Greer, Director, QA & RA |
| Manufacturer: | 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 Maestro System™ Maximus 3.0mm Diameter Implant
Common Name
Screw-type Dental Implant
Classification Name
Endosseous implants, surgical components, and prosthetic attachments
Predicate Devices
Predicate devices are:
-
- The Altiva Natural Tooth Replacement (NTR) System 3.3mm diameter implant, a one-piece screw-type endosseous implant for long-term applications manufactured and distributed by Altiva Corporation and cleared for market under 510(k) number K992512.
Device Description
The BioHorizons Maestro System 3.0mm diameter dental implant is a machined titanium, screw-form implant supplied in lengths of 12mm, 15mm and 18mm. 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 treating the surface with resorbable blast media (RBM). 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, Sterlization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.
1
The Maestro System™ 3.0mm Diameter Implant 510(k) Notification, July 25, 2003 - revised October 16, 2003
The Maestro System™ 3.0mm Diameter Implant is a comprehensive system containing implants and surgical components. The BioHorizons 3.0mm diameter implant may be used: (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion; (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function; (3) 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.
All BioHorizons implants referenced in this submission are 3.0mm in diameter with D3 thread form and surface treated using resorbable blast media (hydroxylapatite conforming to ASTM F 1185, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants). The following table provides a summary of the proposed implant catalog item or reference numbers by length.
| Lengths (mm) | Catalog
REF Numbers |
|--------------|------------------------|
| 12 | 3012D3 |
| 15 | 3015D3 |
| 18 | 3018D3 |
Intended Use
The BioHorizons 3.0mm diameter implant mav be used:
- (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
- (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function.
- (3) 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 or very similar to the referenced predicate devices. All materials, suppliers, processing, packaging and sterilization methods remain the same as for the predicate Maestro System devices. The BioHorizons 3.0mm diameter 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2003
Mr. Weston D. Greer Director Assurance & Regulatory Affairs Biohorizons Implant System, Incorporated One Perimeter Park South Suite 230 South Birmingham, Alabama 35243
Re: K032351
Trade/Device Name: Biohorizons the Maestro System™ 3.0mm Diameter Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: July 25, 2003 Received: July 31, 2003
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.
Patricia Cucarito Flor
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 Maestro System™ 3.0mm Diameter 510(k) Notification, July 25, 2003; revised October 16, 2003
Page 1 of 1
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: BioHorizons The Maestro System™ 3.0mm Diameter Implant
Indications for Use:
The BioHorizons Maestro System 3.0 mm Diameter Implant may be used
- (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
- (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function.
- (3) 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 Runser
510(k) Number. K032235
Prescription Use (per 21 CFR 801.109) OR
Over-the-Counter Use