(15 days)
None
No
The description focuses on the material, design, and physical characteristics of a dental implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a dental implant used as an artificial root structure, which is a replacement rather than a therapeutic treatment for a disease or condition.
No
The device description indicates it is a dental implant for permanent tooth replacement, not a tool for diagnosis.
No
The device description clearly states it is a machined titanium screw-form implant, which is a physical hardware device.
Based on the provided text, the Maestro System™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is described as an "artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention." This is a surgical implant intended to be placed within the body, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a physical implant made of titanium alloy, with specific dimensions and surface treatments. This aligns with a medical device intended for implantation, not an IVD which would typically involve reagents, analyzers, or test kits for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or test kits
The Maestro System™ is clearly described as a dental implant system, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 denture retention.
Product codes
DZE
Device Description
The proposed Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied in diameters of 4.0 mm and 5.0 mm, and in active thread area lengths of 9 mm, 12 mm, and 15 mm. The implant will have a polished collar length of 2 mm. The implant raw material is titanium alloy as specified in ASTM F136 -Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical 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 will be provided sterile, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization, with a minimum sterility assurance level of 10°.
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
dental practitioner
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)
K010458, K960026, K964330, K972313, K010458, K020133
Reference Device(s)
Not Found
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
21 CFR 807.92
02/18/02 Date:
Donald E. Dalton Official Contact:
MAR 1 5 2002
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 implant has been documented under the following 510(k) numbers: K010458, K960026, K964330, K972313, K010458, K020133.
Device Description
The proposed Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied in diameters of 4.0 mm and 5.0 mm, and in active thread area lengths of 9 mm, 12 mm, and 15 mm. The implant will have a polished collar length of 2 mm. The implant raw material is titanium alloy as specified in ASTM F136 -Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical 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 will be provided sterile, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of
BioHorizons Implant Systems, Inc.
The Maestro System ™ 2 mm Polished Collar Length Special 510(k) Summary Page 1 of 3
1
healthcare products - Requirements for validation and routine control - Radiation Sterilization, with a minimum sterility assurance level of 10°.
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.
The following table provides a comprehensive summary of the implant sizes for which authorization to market has been received.
| Diameter | Design | Length (mm) | Coating |
|---|---|---|---|
| Φ3.5 | D2 | 9,12 | RBM |
| D3 | 9,12,15 | RBM | |
| D3 | 9,13 | TPS | |
| Φ4.0 | D1 | 9,11,13 | RBM |
| D2 | 9,12,15 | RBM/HA | |
| D3 | 9,12,14 | TPS | |
| D3 | 9,12,15 | RBM/HA | |
| D4 | 9,12,13,15 | HA | |
| Φ5.0 | D1 | 9,11 | RBM |
| D2 | 9,10,12,15 | RBM | |
| D3 | 9,11,13 | TPS | |
| D3 | 9,12,15 | RBM/HA | |
| D4 | 9,12,14,15 | HA |
Table. Previously cleared implant size (RBM = Resorbable Blast Media Surface, TPS = Titanium Plasma Spray Coating; HA = Hydroxylapatite Coating).
Following five years of clinical use, this submission proposes offering an additional polished collar length and threaded area length to assist the dental practitioner in treatment planning and ease of use with the product. Three base implant designs, corresponding to each bone density classification (D1/D2, D3 and D4) will be available in 4.0 mm and 5.0 mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, will be available in three lengths and may feature a Resorbable Blast Media (RBM) surface treatment, or hydroxylapatite (HA) coating. The following table provides a comprehensive summary of the proposed implant sizes which will include the changes.
BioHorizons Implant Systems, Inc.
The Maestro System ™ 2 mm Polished Collar Length Special 510(k) Summary Page 2 of 3
2
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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 Indication/Intended use of the modified device, the Maestro System™, 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 increase the polished collar length to 2 mm. The overall length of the implant will remain unchanged. All materials, suppliers, processing, packaging and sterilization methods remain the same. The proposed Maestro System ™ dental implant is 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the top and sides of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Mr. Donald E. Dalton Director, Quality Assurance BioHorizons Implants Systems, Incorporated One Perimeter Park South, Suite 200 South Birmingham, Alabama 35243
Re: K020645
Trade/Device Name: The Maestro System™ Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: February 28, 2002 Received: February 28, 2002
Dear Mr. Dalton:
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.
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.
4
Page 2 - Mr. Dalton
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _____ The Maestro System™
Indications for 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 denture retention.
.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
| Division of Dental, Infection Control,
| and General Hospital Devices | |
|---|---|
| 510(k) Number | K020695 |