EdgeOne Fire
- Primary DI
- 07640452461092
- Brand
- EdgeOne Fire
- Company
- FKG Dentaire Sàrl
- Model
- EOF21ASSTD
- Catalog number
- EOF21ASSTD
- Device description
- EdgeOne Fire Assortment - SM 20/PRI 25/MED 35 - 21mm EdgeTaper Platinum, Size F2, 21mm
- Published
- 2026-06-03
- 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 |
|---|---|---|---|---|
| 07640452461092 | Primary | GS1 | 0 | |
| 07640452464178 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07640452461092 | 07640452461092 | 7640452461092 |
| 07640452464178 | 07640452464178 | 7640452464178 |
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
- 482884061
- Device count
- 3
- 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
- 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 |
|---|---|---|---|---|
| 07640452461030 | EdgeGlidepath | EGP0221HTS4 | EGP0221HTS4 | 2026-06-03 |
| 07640452461047 | EdgeGlidepath | EGP0225HTS | EGP0225HTS | 2026-06-03 |
| 07640452461054 | EdgeGlidepath | EGP0231HTS | EGP0231HTS | 2026-06-03 |
| 07640452461061 | EdgeOne Fire | EOF21ASST | EOF21ASST | 2026-06-03 |
| 07640452461078 | EdgeOne Fire | EOF25ASST | EOF25ASST | 2026-06-03 |
| 07640452461085 | EdgeOne Fire | EOF31ASST | EOF31ASST | 2026-06-03 |
| 07640452461108 | EdgeOne Fire | EOF25ASSTD | EOF25ASSTD | 2026-06-03 |
| 07640452461115 | EdgeOne Fire | EOF31ASSTD | EOF31ASSTD | 2026-06-03 |
| 07640452461122 | EdgeOne Fire | EOFLG21HTS | EOFLG21HTS | 2026-06-03 |
| 07640452461139 | EdgeOne Fire | EOFLG25HTS | EOFLG25HTS | 2026-06-03 |
| 07640452461146 | EdgeOne Fire | EOFLG31HTS | EOFLG31HTS | 2026-06-03 |
| 07640452461153 | EdgeOne Fire | EOFMED21HTS | EOFMED21HTS | 2026-06-03 |
| 07640452461160 | EdgeOne Fire | EOFMED25HTS | EOFMED25HTS | 2026-06-03 |
| 07640452461177 | EdgeOne Fire | EOFMED31HTS | EOFMED31HTS | 2026-06-03 |
| 07640452461184 | EdgeOne Fire | EOFPRI21HTS | EOFPRI21HTS | 2026-06-03 |
| 07640452461191 | EdgeOne Fire | EOFPRI25HTS | EOFPRI25HTS | 2026-06-03 |
| 07640452461207 | EdgeOne Fire | EOFPRI31HTS | EOFPRI31HTS | 2026-06-03 |
| 07640452461214 | EdgeOne Fire | EOFSM21HTS | EOFSM21HTS | 2026-06-03 |
| 07640452461221 | EdgeOne Fire | EOFSM25HTS | EOFSM25HTS | 2026-06-03 |
| 07640452461238 | EdgeOne Fire | EOFSM31HTS | EOFSM31HTS | 2026-06-03 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07640452461030 | EdgeGlidepath | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461047 | EdgeGlidepath | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461054 | EdgeGlidepath | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461061 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461078 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461085 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461108 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461115 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461122 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461139 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461146 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461153 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461160 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461177 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461184 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461191 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461207 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461214 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461221 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461238 | EdgeOne Fire | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461245 | EdgeOne Glidepath | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461252 | EdgeOne Glidepath | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452461269 | EdgeOne Glidepath | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452462235 | EdgeTaper | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452462242 | EdgeTaper | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452462259 | EdgeTaper | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452462266 | EdgeTaper | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452462273 | EdgeTaper | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452462280 | EdgeTaper | FKG Dentaire Sàrl | EKS | 2026-06-03 |
| 07640452462297 | EdgeTaper | FKG Dentaire Sàrl | EKS | 2026-06-03 |