(10 days)
Not Found
No
The description focuses on the material, design, and sizing of a dental implant system, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats a disease or condition. This device is an artificial root structure for tooth replacement, which is a restorative rather than a therapeutic function.
No
Explanation: The device is a dental implant system used as an artificial root structure or abutments for fixed bridgework, not for diagnosing medical conditions.
No
The device description clearly details physical components made of titanium alloy, including screw-type dental implants, surgical components, and prosthetic components. There is no mention of software as the primary or sole component.
Based on the provided text, the Maestro System™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Maestro System™ Function: The description clearly states the Maestro System™ is a dental implant system used as an artificial root structure for tooth replacement and as abutments for bridgework and retention. It is a physical device implanted into the body.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze biological samples or provide diagnostic information. Its purpose is structural and restorative.
Therefore, the Maestro System™ falls under the category of a medical device, specifically a dental implant, rather than 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 dental retention.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The 15 mm length Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied in diameters of 3.5 mm , 4.0 mm and 5.0 mm, and in lengths of 9 mm, 12 mm, and15 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.
Following four years of clinical use, this submission proposes altered sizing 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 3.5 mm, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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.
K010458, K972313, K960026, K964330
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
21 CFR 807.92
12/27/01 Date:
Donald E. Dalton Official Contact:
JAN 2 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, K972313, K960026, K964330.
Device Description
The 15 mm length Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied in diameters of 3.5 mm , 4.0 mm and 5.0 mm, and in lengths of 9 mm, 12 mm, and15 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
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 | Lengths (mm) | Coating |
|---|---|---|---|
| $3.5 | D2 | 9, 12 | RBM |
| D3 | 9, 13 | TPS | |
| $4.0 | D1 | 9, 11, 13 | RBM |
| D2 | RBM | ||
| D3 | 9, 12, 14 | TPS | |
| D4 | 9, 13, 15 | HA | |
| $5.0 | D1 | 9, 11 | RBM |
| D2 | 10, 12 | RBM | |
| D3 | 9, 11, 13 | TPS | |
| D4 | 9, 12, 14 | HA |
Table. Previously cleared implant size (RBM = Resorbable Blast Media Surface; TPS = Titanium Plasma Spray Coating; HA = Hydroxylapatite Coating).
Following four years of clinical use, this submission proposes altered sizing 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 3.5 mm, 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 new implant sizes.
2
| Diameter | Design | Lengths (mm) | Coating |
|---|---|---|---|
| $\phi3.5$ | D3 | 9, 12, 15 | RBM |
| $\phi4.0$ | D2 | 9, 12, 15 | RBM, HA |
| D3 | 9, 12, 15 | RBM, HA | |
| D4 | 9, 12, 15 | HA | |
| $\phi5.0$ | D2 | 9, 12, 15 | RBM, HA |
| D3 | 9, 12, 15 | RBM, HA | |
| D4 | 9, 12, 15 | HA |
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 reinstate an implant with a 15 mm overall length which includes an apical geometry configuration that reduces the insertion force required (as measured in torque) to place the implant. All materials, suppliers, processing, packaging and sterilization methods remain the same. The 15 mm length 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
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
Mr. Donald E. Dalton Director, Quality Assurance BioHorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 South Birmingham, Alabama 35243
Re: K020133
Trade/Device Name: The Maestro System™ Regulation Number: 872.3640 Regulation Name: Screw-Type Implants Regulatory Class: III Product Code: DZE Dated: January 15, 2002 Received: January 15, 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
Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): _ KO20133
The Maestro System™ Device Name:
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 dental 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) Over-the-Counter Use
Susan Purro
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
OR