(14 days)
Not Found
No
The description focuses on the material, design, and sterilization of dental implants, with no mention of AI or ML.
No.
The device is described as an artificial root structure for tooth replacement, which is a prosthetic device, not a therapeutic one that treats or cures a disease.
No
The device is described as an endosseous implant for tooth replacement and fixed bridgework, which are therapeutic and restorative functions, not diagnostic ones.
No
The device description clearly states it 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:
- Intended Use: The intended use clearly states that the Maestro System™ endosseous implants are used as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention. This is a surgical implant intended to be placed directly into the body.
- Device Description: The description details a physical implant made of titanium, designed for surgical implantation and interaction with bone.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The Maestro System™ is a medical device, specifically a dental implant, used in a surgical procedure. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Maestro System™ endosseous implants 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 dental retention.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The 7mm and 10.5mm length Maestro System dental implants are a machined titanium. screw-form implant supplied in diameters of 3.5mm, 4mm and 5mm. Implant raw material is titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surqical Implant Applications.
The device is further processed by treating the surface with resorbable blast media (RBM) or coating with synthetic hydroxylapatite (HA). 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 108, validated in compliance to ANSI/AAMI/ISO 11137. Sterilization of healthcare products - Requirements for validation and routine control - Radiation sterilization.
The Maestro System ™ is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This is achieved by optimizing implant designs based on bone quality.
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.)
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.
K960026, K964330, K972313, K010458, K020133, K020645, K022795
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. The Maestro System™ 7mm & 10.5mm 510(k) Notification: Special 510(k) - Device Modification 02/10/03
510(k) summary
21 CFR 807.92
02/10/03 Date:
Official Contact: Winston Greer, Director, QA & RA FEB 2 6 2003
BioHorizons Implant Systems, Inc. Manufacturer: One Perimeter Park South Suite 230 South Birmingham, AL 35243 Phone: (205) 967-7880 Fax: (205) 870-0304
Proprietary Name
The Maestro System™
Common Name
Screw-type Dental Implant
Classification Name
Endosseous implants, surgical components, and prosthetic attachments
Predicate Device
The predicate device is The Maestro System ™, a screw-type dental implant manufactured and distributed by BioHorizons Implant Systems Inc. Authorization to legally market the predicate BioHorizons Maestro System dental implants has been documented under the following 510(k) numbers: K960026, K964330, K972313, K010458, K020133, K020645, and K022795.
Device Description
The 7mm and 10.5mm length Maestro System dental implants are a machined titanium. screw-form implant supplied in diameters of 3.5mm, 4mm and 5mm. Implant raw material is titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surqical Implant Applications.
The device is further processed by treating the surface with resorbable blast media (RBM) or coating with synthetic hydroxylapatite (HA). 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 108, validated in compliance to ANSI/AAMI/ISO 11137. Sterilization of healthcare products - Requirements for validation and routine control - Radiation sterilization.
The Maestro System ™ is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This is achieved by optimizing implant designs based on bone quality.
1
| Diameter
(mm) | Lengths
(mm) | Design | Coating | Catalog
REF Numbers |
|------------------|-----------------|--------|---------|------------------------|
| $\phi$3.5 | 7, 10.5 | D3 | RBM | 3507D3, 35105D3 |
| | 7 | D3 | HA | 3507D3-HA |
| $\phi$4 | 10.5 | D2 | RBM | 40105D2 |
| $\phi$4 | 7, 10.5 | D3 | RBM | 4007D3, 40105D3 |
| | 7 | D3 | HA | 4007D3-HA |
| $\phi$4 | 7, 10.5 | D4 | RBM | 40105D4 |
| $\phi$5 | 10.5 | D2 | RBM | 50105D2 |
| $\phi$5 | 7, 10.5 | D3 | RBM | 5007D3, 50105D3 |
| | 7 | D3 | HA | 5007D3-HA |
| $\phi$5 | 7, 10.5 | D4 | RBM | 50105D4 |
The following table provides a summary of the proposed new implant sizes
Intended Use
The Maestro System™ 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 dental retention. The indications and intended use of the modified Maestro System™ endosseous implants as described in its labeling has not changed.
Technological Characteristics
The fundamental scientific technology of the modified device has not changed; the only change has been to add implant lengths of 7mm and 10.5mm. All materials, suppliers, processing, packaging and sterilization methods remain the same. The 7mm and 10.5mm length Maestro System ™ dental implants are substantially equivalent to all features of the predicate devices which could affect safety or effectiveness due to the similarities in design, material and intended use.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into its design.
Public Health Service
FEB 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Winston Greer Director, QA/RA BioHorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 South Birmingham, Alabama 35243
Re: K030463
Trade/Device Name: The Maestro System™ 7mm & 10.5 Endosseous Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: February 10, 2003 Received: February 12, 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 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 (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.
Susan Runes
Susan Runner, DDS, MA Interim 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™ 7mm & 10.5mm Special 510(k) Notification - Device Modification 02/10/03
Page 1 of 1
510(k) Number (if known): __
Device Name: The Maestro System™ 7mm & 10.5mm Endosseous Implants
Indications for Use:
The Maestro System™ endosseous implants 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 dental retention.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Riones
(Division Sign-Off) Division of Anesthesiology. General Hospital, Infection Control, Dental I
510(k) Number. K030463
Prescription Use
(per 21 CFR 801.109) X
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________