Eighteeth
- Primary DI
- 06941877830083
- Brand
- Eighteeth
- Company
- Changzhou Sifary Medical Technology Co., Ltd.
- Model
- E-FLEX REC-202
- Catalog number
- 5183105
- Device description
- Endodontic Files are used in endodontic treatment for dentin removal and root canal shaping. These files must only be used in hospital environments, clinics or dental offices by a trained and qualified dentist or dental technician.
- Published
- 2026-05-26
- 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
- false
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 |
|---|---|---|---|---|
| 06941877830083 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06941877830083 | 06941877830083 | 6941877830083 |
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. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 560366787
- Device count
- 1
- 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
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06941877830076 | Eighteeth | E-FLEX REC-201 | 5183104 | 2026-05-26 |
| 06941877827809 | Zarc | Z-Evo | 6080279 | 2026-01-05 |
| 06941877827816 | Zarc | Z-Down | 6380038 | 2026-01-05 |
| 06941877827823 | Zarc | Z-Up | 6380125 | 2026-01-05 |
| 06941877819231 | Eighteeth | Lux-SFT | 5080901 | 2025-04-17 |
| 06941877819248 | Eighteeth | Wireless Z | 5080902 | 2025-04-17 |
| 06941877821456 | Eighteeth | Acuvision X | 5380009 | 2025-04-17 |
| 06941877822248 | Eighteeth | Wireless Z+ | 5080909 | 2025-04-17 |
| 06941877815196 | Eighteeth | NanoPix1.5 | 6980098 | 2025-01-21 |
| 06941877803193 | Eighteeth | HyperLight | 2024-03-26 | |
| 06941877802967 | Eighteeth | ibG3050S | 2024-03-25 | |
| 06941877802974 | Eighteeth | ibG3050S | 2024-03-25 | |
| 06941877802981 | Eighteeth | ibG3050S | 2024-03-25 | |
| 06941877802998 | Eighteeth | ibG3050S | 2024-03-25 | |
| 06941877803001 | Eighteeth | ibG3050S | 2024-03-25 | |
| 06941877803018 | Eighteeth | ibG3050D | 2024-03-25 | |
| 06941877803025 | Eighteeth | ibG3050D | 2024-03-25 | |
| 06941877803032 | Eighteeth | ibG3050D | 2024-03-25 | |
| 06941877803049 | Eighteeth | ibG3050D | 2024-03-25 | |
| 06941877803056 | Eighteeth | ibG3050D | 2024-03-25 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06941877830076 | Eighteeth | Changzhou Sifary Medical Technology Co., Ltd. | EKS | 2026-05-26 |
| 80810213810008 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810015 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810022 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810039 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810046 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810053 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810060 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810077 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810084 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810091 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810107 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810114 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810121 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810138 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810145 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810152 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810169 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810176 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810183 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810190 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810206 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810213 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810220 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810237 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810244 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810251 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810268 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810275 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810282 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |