Maestro System Modification
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- BioHorizons EUDAMEDFDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- Additional Instruments EUDAMED30 Degree Angled Parallel Pin FDA UDI
- Model / Reference
- 144-230 EUDAMEDFDA UDIBioHorizons Dental Instruments EUDAMED
- Description
- 30 Degree Angled Parallel Pin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847236008673 EUDAMEDFDA UDI
- Basic UDI-DI
- 08472360IRINST005F2 EUDAMED
- Direct Marketing DI
- 00847236018726 EUDAMED
- 510(k) Number
- K020133 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implantation depth/angle gauge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Maestro System Modification is a screw-type dental implant system designed as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention. It falls under the category of dental implants, providing a stable foundation for prosthetic dental restorations in the mandible or maxilla.
This system is supplied as a titanium alloy implant (ASTM F136) with either a resorbable blast media (RBM) surface treatment or a synthetic hydroxylapatite (HA) coating. The device is intended for use in dental settings and is regulated under FDA 510K and MDR authorizations. Implants are classified under product code DZE and are intended for single-use applications.
Frequently asked questions
What types of dental restorations can the Maestro System Modification support, and how does the surface treatment affect its use?
The Maestro System Modification is designed to support single-tooth replacements or serve as abutments for fixed bridgework and dental retention, providing a stable foundation for prosthetic restorations in either the mandible or maxilla. The system offers two surface treatments: a resorbable blast media (RBM) surface or a synthetic hydroxylapatite (HA) coating. The RBM surface enhances osseointegration by promoting bone growth, while the HA coating provides a biologically compatible surface that may further improve integration with natural bone, both contributing to long-term stability.
Is the Maestro System Modification intended for reuse, or is it meant to be used only once per patient?
The Maestro System Modification is explicitly classified for single-use applications. This means each implant is designed to be used once per patient and should not be reused, adhering to standard dental implant protocols for infection control and patient safety.
What material is the Maestro System Modification made from, and why is this important for dental implants?
The Maestro System Modification is constructed from titanium alloy (ASTM F136), a material widely used in dental implants due to its biocompatibility, strength, and resistance to corrosion. Titanium alloy is preferred because it integrates well with bone tissue, reducing the risk of rejection or adverse reactions, and provides the necessary durability for long-term dental restoration.
How is the Maestro System Modification regulated, and what does this mean for clinicians using it?
The Maestro System Modification is regulated under both FDA 510K and MDR (Medical Device Regulation) authorizations, indicating it has undergone review for safety and effectiveness. Clinicians can rely on this regulatory clearance to ensure the device meets established standards for dental implants, though they should always follow manufacturer guidelines and local clinical protocols for proper use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODIFICATION TO THE MAESTRO SYSTEM by BIOHORIZONS IMPLANT SYSTEMS, INC ..., MODIFICATION TO THE MAESTRO SYSTEM - Innolitics, MODIFICATION TO THE MAESTRO SYSTEM - Innolitics, Modification To The Maestro System 510 (k) FDA Premarket Notification ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K020133 | Class II | Active |
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Manufacturer
- Manufacturer
- BioHorizons Implant Systems, Inc.
Sources (3)
- FDA 510(k) K020133 24 fields · synced Sep 18, 2026
- FDA UDI 11a880e6-f99b-44b9-a9c8-212bf69d74a1 33 fields · synced May 30, 2026
- EUDAMED 1bc458d8-254f-4529-9ef2-0b2655064441 61 fields · synced Jul 16, 2026