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Sign in to claim this brandDARBY DENTAL SUPPLY, LLC
US
Last updated May 24, 2026
What DARBY DENTAL SUPPLY, LLC makes
The company produces reusable dental instruments for endodontic and restorative procedures, including manual and rotary endodontic files, carbide and diamond burs, and dental elevators. It also supplies single-use rotary/reciprocating endodontic files, preformed root canal posts, endodontic paper points, and silicone impression materials for dental impressions.
These devices are classified under FDA’s regulatory categories as Class I and Class II, with most entries listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
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 Darby Dental Supply, LLC manufacture?
Darby Dental Supply, LLC specializes in dental instruments primarily used in endodontic (root canal) and restorative procedures. Their product line includes reusable devices like manual and rotary endodontic files, carbide and diamond dental burs, and dental elevators. They also supply single-use rotary/reciprocating endodontic files, preformed root canal posts, endodontic paper points, and silicone dental impression materials for creating molds of teeth.
Where is Darby Dental Supply, LLC based?
The company is headquartered in the United States. This location influences its regulatory compliance, as it must adhere to U.S. standards, including FDA requirements for device classification and listing.
Which regulatory registries list Darby Dental Supply, LLC’s devices?
Darby Dental Supply, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices under FDA oversight, ensuring traceability and compliance with U.S. regulations.
How are Darby Dental Supply, LLC’s devices classified under FDA regulations?
The company’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- darby.com
- —
- —
- [email protected]
- Phone
- +1(516)688-6800
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 825137818
Catalogue (3807)
Page 5 of 77| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Darby Dental Supply, LLC | 9507589 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9516470 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5252480 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9515182 | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | 544CG-DAR | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | 5250436 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9520956 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5250416 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 3181013 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 3410506 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9430884 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 250026 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9542842 | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | N/A | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | 5257124 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9517537 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9512781 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9527643 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9527515 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9514867 | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | 9521091 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9430826 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9520609 | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | 250051 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 901-000212 | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | 5251143 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5257217 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5257025 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9514204 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 3410967 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5257342 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5257308 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9500141 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9508848 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5252758 | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | 5254494 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | HP 38 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5250828 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9547587 | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | 5257295 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5257209 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 250038 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9500922 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | mk-5103 | FDA UDI | Class II | Active |
| Darby Dental Supply, LLC | 5257310 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5257225 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 5250442 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 0758513 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9518630 | FDA UDI | Class I | Active |
| Darby Dental Supply, LLC | 9512091 | FDA UDI | Class I | Active |
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