KOMET Root Canal Files
- Primary DI
- E226100167828
- Brand
- KOMET Root Canal Files
- Company
- Gebr. Brasseler GmbH & Co. KG
- Model
- FQ04L31.204.030.G1
- Catalog number
- FQ04L31.204.030
- Published
- 2023-04-06
- 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
- 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 |
|---|
| E226100167821 | Primary | HIBCC | 0 | |
| E226100167828 | Unit of Use | HIBCC | 0 | |
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. |
Regulatory Flags
- DUNS number
- 317409001
- Device count
- 6
- 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
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|---|
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| 24053613295936 | Bur, Round, round shank | 08226790 | 08226790 | 2026-03-11 |
| 24053613296131 | Bur, Round, round shank | 08227000 | 08227000 | 2026-03-11 |
| 24053613296193 | Bur, tapered, round shank | 08227090 | 08227090 | 2026-03-11 |
| 24053613296803 | Bur, Round, round shank | 08227750 | 08227750 | 2026-03-11 |
| 24053613297121 | Bur, cylindrical, round shank | 08228070 | 08228070 | 2026-03-11 |
| 24053613297190 | Bur, Egg / egg shaped, round shank | 08228140 | 08228140 | 2026-03-11 |
| 24053613297206 | Bur, Egg / egg shaped, round shank | 08228150 | 08228150 | 2026-03-11 |
| 24053613297220 | Bur, Round, round shank | 08228170 | 08228170 | 2026-03-11 |
| 04053613298315 | Guide Pin Smooth | 800-05-215 | 800-05-215 | 2026-03-11 |
| 84053613294535 | Guide Pin Smooth | 800-05-215 | 800-05-215 | 2026-01-30 |
| 24053613295721 | Shannon Recta X-Larga | G01 S5330 | G01 S5330 | 2026-01-23 |
| 24053613284978 | Saw Blade | 5109-098-043 | 5109-098-043 | 2022-12-08 |
| E226048483R18 | KOMET Root Canal Files | 17331.654.012.R1 | 17331.654.012 | 2026-01-13 |
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| 24053613294557 | Guide Drill Pin | 800-02-508 | 800-02-508 | 2026-01-06 |
| 14053613294574 | Tech Knee Pack | 150-00-001 | 150-00-001 | 2026-01-06 |
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