X-Plorer™ Canal Navigation Files 20/.02 (25mm)
- Primary DI
- 07540172013291
- Brand
- X-Plorer™ Canal Navigation Files 20/.02 (25mm)
- Company
- CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Model
- 311024
- Catalog number
- 311024
- Device description
- Endodontic surgical files
- Published
- 2020-03-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- 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 |
|---|
| 07540172013291 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07540172013291 | 07540172013291 | 7540172013291 |
GMDN Terms
| Term | Definition |
|---|
| Rotary/reciprocating endodontic file/rasp, reusable | 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 reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 626406016
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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clinicianschoice.com