EdgeEndo
- Primary DI
- 00810213812471
- Brand
- EdgeEndo
- Company
- HSG-S Corp.
- Model
- EOBU3521SU
- Device description
- EdgeOne Blaze Utopia™ R35 L21 (35/06V)
- Published
- 2026-06-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- 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 |
|---|---|---|---|---|
| 00810213812471 | Primary | GS1 | 0 | |
| 80810213812477 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810213812471 | 00810213812471 | 810213812471 | 0810213812471 |
| 80810213812477 | 80810213812477 |
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
- 144949235
- Device count
- 3
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00810213814697 | EdgeEndo® EdgeCore™ for EdgeTaper™ | ET2006C | 2026-08-19 | |
| 00810213814703 | EdgeEndo® EdgeCore™ for EdgeTaper™ | ET2506C | 2026-08-19 | |
| 00810213814710 | EdgeEndo® EdgeCore™ for EdgeTaper™ | ET3006C | 2026-08-19 | |
| 00810213814727 | EdgeEndo® EdgeCore™ for EdgeTaper™ | ET4006C | 2026-08-19 | |
| 00810213814741 | EdgeEndo® EdgeFill™ for EdgeTaper™ | ET2006O | 2026-08-19 | |
| 00810213814758 | EdgeEndo® EdgeFill™ for EdgeTaper™ | ET2506O | 2026-08-19 | |
| 00810213814765 | EdgeEndo® EdgeFill™ for EdgeTaper™ | ET3006O | 2026-08-19 | |
| 00810213814789 | EdgeEndo® EdgeFill™ for EdgeTaper™ | ET5006O | 2026-08-19 | |
| 00810213814796 | EdgeEndo® EdgeVerify™ | X72006V | 2026-08-19 | |
| 00810213814802 | EdgeEndo® EdgeVerify™ | X72506V | 2026-08-19 | |
| 00810213814819 | EdgeEndo® EdgeVerify™ | X73006V | 2026-08-19 | |
| 00810213814833 | EdgeEndo® EdgeVerify™ | X74006V | 2026-08-19 | |
| 00810213814840 | EdgeEndo® EdgeVerify™ | X74506V | 2026-08-19 | |
| 00810213814857 | EdgeEndo® EdgeVerify™ | X75006V | 2026-08-19 | |
| 00810213814864 | EdgeEndo® EdgeCore™ for EdgeOne™ | EOPSM20C | 2026-08-19 | |
| 00810213814871 | EdgeEndo® EdgeCore™ for EdgeOne™ | EOPPRI25C | 2026-08-19 | |
| 00810213814895 | EdgeEndo® EdgeCore™ for EdgeOne™ | EOPLG45C | 2026-08-19 | |
| 00810213814901 | EdgeEndo® EdgeFill™ for EdgeOne™ | EOPSM20O | 2026-08-19 | |
| 00810213814918 | EdgeEndo® EdgeFill™ for EdgeOne™ | EOPPRI25O | 2026-08-19 | |
| 00810213814932 | EdgeEndo® EdgeFill™ for EdgeOne™ | EOPLG45O | 2026-08-19 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00850085821171 | K File | CREATIVE ENDODONTIC TECHNOLOGY LLC | EKS | 2026-07-21 |
| 00850085821188 | K File | CREATIVE ENDODONTIC TECHNOLOGY LLC | EKS | 2026-07-21 |
| 00850085821195 | K File | CREATIVE ENDODONTIC TECHNOLOGY LLC | EKS | 2026-07-21 |
| 00850085821201 | H Files | CREATIVE ENDODONTIC TECHNOLOGY LLC | EKS | 2026-07-21 |
| 00810213812419 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812426 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812433 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812440 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812457 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812464 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812488 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812495 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812501 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812518 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812525 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812532 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812549 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812556 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812563 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812570 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812587 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812594 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812600 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812617 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812624 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812631 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812648 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812655 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812662 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812679 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |