Endodontic Hand Instruments
- Primary DI
- D80907325100R0
- Brand
- Endodontic Hand Instruments
- Company
- ROYDENT DENTAL PRODUCTS INC
- Model
- 06325025R
- Catalog number
- 07325100R
- Device description
- HEDSTROM FILES 25MM 100
- Published
- 2022-11-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- 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 |
|---|
| D80907325100R1 | Primary | HIBCC | 0 | |
| D80907325100R0 | Unit of Use | HIBCC | 0 | |
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
- 131487225
- Device count
- 6
- 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
- false
- Expiration date on label
- false
- 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 |
|---|
| D80906319015R0 | Endodontic Hand Instruments | 06319015R | 06319015R | 2022-11-29 |
| D80906319010R0 | Endodontic Hand Instruments | 06319010R | 06319010R | 2022-11-10 |
| D80906319020R0 | Endodontic Hand Instruments | 06319020R | 06319020R | 2022-11-09 |
| D80906319025R0 | Endodontic Hand Instruments | 06319025R | 06319025R | 2022-11-09 |
| D80906319160R0 | Endodontic Hand Instruments | 06319160R | 06319160R | 2022-11-09 |
| D80906321006R0 | Endodontic Hand Instruments | 06321006R | 06321006R | 2022-11-09 |
| D80906321008R0 | Endodontic Hand Instruments | 06321008R | 06321008R | 2022-11-09 |
| D80906321010R0 | Endodontic Hand Instruments | 06321010R | 06321010R | 2022-11-09 |
| D80906321012R0 | Endodontic Hand Instruments | 06321012R | 06321012R | 2022-11-09 |
| D80906321015R0 | Endodontic Hand Instruments | 06321015R | 06321015R | 2022-11-09 |
| D80906321017R0 | Endodontic Hand Instruments | 06321017R | 06321017R | 2022-11-09 |
| D80906321020R0 | Endodontic Hand Instruments | 06321020R | 06321020R | 2022-11-09 |
| D80906321025R0 | Endodontic Hand Instruments | 06321025R | 06321025R | 2022-11-09 |
| D80906321030R0 | Endodontic Hand Instruments | 06321030R | 06321030R | 2022-11-09 |
| D80906321035R0 | Endodontic Hand Instruments | 06321035R | 06321035R | 2022-11-09 |
| D80906321040R0 | Endodontic Hand Instruments | 06321040R | 06321040R | 2022-11-09 |
| D80906321045R0 | Endodontic Hand Instruments | 06321045R | 06321045R | 2022-11-09 |
| D80906321050R0 | Endodontic Hand Instruments | 06321050R | 06321050R | 2022-11-09 |
| D80906321055R0 | Endodontic Hand Instruments | 06321055R | 06321055R | 2022-11-09 |
| D80906321060R0 | Endodontic Hand Instruments | 06321060R | 06321060R | 2022-11-09 |
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