EdgeEndo
- Primary DI
- 00810213812969
- Brand
- EdgeEndo
- Company
- HSG-S Corp.
- Model
- EOASST21HTX
- Device description
- EdgeOnyx, x-Find: Size 09.09 -15mm, x-Follow: Size 15.04 - 21mm, x-Finish: Size 20.04, 25.04, 30.04, 35.04 - 21mm
- Published
- 2026-03-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- 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 |
|---|---|---|---|---|
| 00810213812969 | Primary | GS1 | 0 | |
| 80810213812965 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810213812969 | 00810213812969 | 810213812969 | 0810213812969 |
| 80810213812965 | 80810213812965 |
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
- 6
- Premarket exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00810213812419 | EdgeEndo | EOBU2021SU | 2026-06-24 | |
| 00810213812426 | EdgeEndo | EOBU2025SU | 2026-06-24 | |
| 00810213812433 | EdgeEndo | EOBU2031SU | 2026-06-24 | |
| 00810213812440 | EdgeEndo | EOBU2521SU | 2026-06-24 | |
| 00810213812457 | EdgeEndo | EOBU2525SU | 2026-06-24 | |
| 00810213812464 | EdgeEndo | EOBU2531SU | 2026-06-24 | |
| 00810213812471 | EdgeEndo | EOBU3521SU | 2026-06-24 | |
| 00810213812488 | EdgeEndo | EOBU3525SU | 2026-06-24 | |
| 00810213812495 | EdgeEndo | EOBU3531SU | 2026-06-24 | |
| 00810213812501 | EdgeEndo | EOBU4521SU | 2026-06-24 | |
| 00810213812518 | EdgeEndo | EOBU4525SU | 2026-06-24 | |
| 00810213812525 | EdgeEndo | EOBU4531SU | 2026-06-24 | |
| 00810213812532 | EdgeEndo | EOBUA21SU | 2026-06-24 | |
| 00810213812549 | EdgeEndo | EOBUA25SU | 2026-06-24 | |
| 00810213812556 | EdgeEndo | EOBUA31SU | 2026-06-24 | |
| 00810213812563 | EdgeEndo | EOBURG1421SU | 2026-06-24 | |
| 00810213812570 | EdgeEndo | EOBURG1425SU | 2026-06-24 | |
| 00810213812587 | EdgeEndo | EOBURG1431SU | 2026-06-24 | |
| 00810213812594 | EdgeEndo | ETBUA21SU | 2026-06-24 | |
| 00810213812600 | EdgeEndo | ETBUA25SU | 2026-06-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 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 |
| 00810213812471 | 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 |
| 00810213812686 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812693 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |
| 00810213812709 | EdgeEndo | HSG-S Corp. | EKS | 2026-06-24 |