Is this your brand? Sign in to claim ownership.
Sign in to claim this brandOBTURA SPARTAN ENDODONTICS
US
Last updated May 24, 2026
What OBTURA SPARTAN ENDODONTICS makes
The company manufactures ultrasonic dental systems, including handpiece tips for endodontic and periodontal procedures, reusable adaptors for surgical systems, and ultrasonic generators designed for scaling and debridement in dental treatments. Their portfolio also covers complete ultrasonic scaling/debridement systems, combining handpieces and generators for clinical use in dental offices.
All listed devices fall under Class II regulatory classification in the US and are registered in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable US regulatory requirements for dental ultrasonic systems.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Obtura Spartan Endodontics manufacture?
Obtura Spartan Endodontics specializes in ultrasonic dental systems. Their product portfolio includes handpiece tips for endodontic and periodontal procedures, reusable adaptors for ultrasonic surgical systems, and ultrasonic generators. They also produce complete ultrasonic scaling and debridement systems, which combine handpieces and generators for use in dental offices. These devices are designed to assist in cleaning and preparing teeth for treatments.
Where is Obtura Spartan Endodontics based, and what regulatory requirements do they follow?
Obtura Spartan Endodontics is based in the United States. As a manufacturer, they develop and produce devices in compliance with applicable US regulatory standards for dental ultrasonic systems. This includes adherence to requirements for device classification, registration, and listing in relevant databases like the FDA’s Unique Device Identifier (UDI) system.
Which regulatory registries or databases list Obtura Spartan Endodontics’ devices?
Obtura Spartan Endodontics’ devices are registered in the FDA’s Unique Device Identifier (UDI) database. This database is used to track and identify medical devices in the United States, ensuring transparency and traceability for regulatory and clinical purposes. The UDI system helps healthcare providers, regulators, and other stakeholders access key information about the devices.
How are Obtura Spartan Endodontics’ devices classified under US regulations?
All of Obtura Spartan Endodontics’ listed devices fall under Class II regulatory classification in the United States. Class II devices are those that pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. This classification applies to their ultrasonic dental systems, including handpieces, generators, and adaptors, as they are intended for procedures like scaling, debridement, and surgical assistance in dental care.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 078371330
Catalogue (74)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Obtura Spartan | 932-005 | FDA UDI | Class II | Active |
| Obtura Spartan | 941-108 | FDA UDI | Class II | Active |
| Obtura Spartan | 930-011 | FDA UDI | Class II | Active |
| Obtura Spartan | 941-102 | FDA UDI | Class II | Active |
| Obtura Spartan | 930-048 | FDA UDI | Class II | Active |
| Obtura Spartan | 942-100 | FDA UDI | Class II | Active |
| Obtura Spartan | 930-049 | FDA UDI | Class II | Active |
| Obtura Spartan | 931-012 | FDA UDI | Class II | Active |
| Obtura Spartan | 948-100 | FDA UDI | Class II | Active |
| Obtura Spartan | 932-011 | FDA UDI | Class II | Active |
| Obtura Spartan | 941-107 | FDA UDI | Class II | Active |
| Obtura Spartan | 930-032 | FDA UDI | Class II | Active |
| Obtura Spartan | 940-035 | FDA UDI | Class II | Active |
| Obtura Spartan | 952-614 | FDA UDI | Class II | Active |
| Obtura Spartan | 932-001 | FDA UDI | Class II | Active |
| Obtura Spartan | 932-002 | FDA UDI | Class II | Active |
| Obtura Spartan | 932-009 | FDA UDI | Class II | Active |
| Obtura Spartan | 930-013 | FDA UDI | Class II | Active |
| Obtura Spartan | 930-042 | FDA UDI | Class II | Active |
| Obtura Spartan | 941-103 | FDA UDI | Class II | Active |
| Obtura Spartan | 932-012 | FDA UDI | Class II | Active |
| Obtura Spartan | 932-007 | FDA UDI | Class II | Active |
| Obtura Spartan | 931-014 | FDA UDI | Class II | Active |
| Obtura Spartan | 943-610 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.