Darby Dental Supply, LLC
- Primary DI
- 00889813028131
- Brand
- Darby Dental Supply, LLC
- Company
- DARBY DENTAL SUPPLY, LLC
- Model
- 9510153
- Catalog number
- 9510153
- Device description
- ROTARY FINISH FILE 20/04 31MM
- Published
- 2020-01-18
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| EKS | FILE, PULP CANAL, ENDODONTIC |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EKS | File, Pulp Canal, Endodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00889813028131 | Primary | GS1 | 0 | |
| 00889813028124 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00889813028131 | 00889813028131 | 889813028131 | 0889813028131 |
| 00889813028124 | 00889813028124 | 889813028124 | 0889813028124 |
GMDN Terms
| Term | Definition |
|---|
| Rotary/reciprocating endodontic file/rasp, single-use | A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device. |
Regulatory Flags
- DUNS number
- 825137818
- Device count
- 6
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
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|---|
| 00889813067970 | Darby Dental Supply, LLC | 9537746 | | 2026-03-22 |
| 00889813067987 | Darby Dental Supply, LLC | 9537750 | | 2026-03-22 |
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| 10889813067793 | Darby Dental Supply, LLC | 9553145 | | 2025-07-02 |
| 10889813067809 | Darby Dental Supply, LLC | 9553146 | | 2025-07-02 |
| 10889813067816 | Darby Dental Supply, LLC | 9553147 | | 2025-07-02 |
| 10889813067823 | Darby Dental Supply, LLC | 9553148 | | 2025-07-02 |
Other Devices Sharing Product Codes
darby.com