SureFlex NiTi Rotary File
- Primary DI
- D7166640110
- Brand
- SureFlex NiTi Rotary File
- Company
- TULSA DENTAL PRODUCTS LLC
- Model
- 664011
- Catalog number
- 664011
- Device description
- SureFlex NiTi Rotory Files 015-040/21mm
- Published
- 2022-10-27
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| EFA | Handpiece, belt and/or gear driven, dental |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D7166640111 | Primary | HIBCC | 0 | |
| D7166640110 | 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. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 942778564
- Device count
- 6
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- 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 |
|---|---|---|---|---|
| D716PUENDO11 | ProUltra | PUENDO1 | PUENDO1 | 2016-10-07 |
| D716PUENDO151 | ProUltra | PUENDO1-5 | PUENDO1-5 | 2016-11-11 |
| D716PUENDO21 | ProUltra | PUENDO2 | PUENDO2 | 2016-10-07 |
| D716PUENDO31 | ProUltra | PUENDO3 | PUENDO3 | 2016-10-07 |
| D716PUENDO41 | ProUltra | PUENDO4 | PUENDO4 | 2016-10-07 |
| D716PUENDO51 | ProUltra | PUENDO5 | PUENDO5 | 2016-10-07 |
| D716PUENDO61 | ProUltra | PUENDO6 | PUENDO6 | 2016-10-07 |
| D716PUENDO681 | ProUltra | PUENDO6-8 | PUENDO6-8 | 2016-11-11 |
| D716PUENDO71 | ProUltra | PUENDO7 | PUENDO7 | 2016-10-07 |
| D716PUENDO81 | ProUltra | PUENDO8 | PUENDO8 | 2016-10-07 |
| D716PUSINE11 | ProUltra | PUSINE1 | PUSINE1 | 2016-10-07 |
| D716PUSINE161 | ProUltra SINE | PUSINE1-6 | PUSINE1-6 | 2016-11-11 |
| D716PUSINE21 | ProUltra | PUSINE2 | PUSINE2 | 2016-10-07 |
| D716PUSINE31 | ProUltra SINE | PUSINE3 | PUSINE3 | 2016-10-07 |
| D716PUSINE41 | ProUltra SINE | PUSINE4 | PUSINE4 | 2016-10-07 |
| D716PUSINE51 | ProUltra SINE | PUSINE5 | PUSINE5 | 2016-10-07 |
| D716PUSINE61 | ProUltra SINE | PUSINE6 | PUSINE6 | 2016-10-07 |
| D716PUSURG11 | ProUltra | PUSURG1 | PUSURG1 | 2016-10-07 |
| D716PUSURG161 | ProUltra | PUSURG1-6 | PUSURG1-6 | 2016-11-11 |
| D716PUSURG21 | ProUltra | PUSURG2 | PUSURG2 | 2016-10-07 |
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| 04548213745043 | Midwest 45 FBE NFO | J.MORITA MFG.CORP. | EFA | 2023-08-18 |
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| 10194665005528 | A-dec | A-DEC, INC. | EFA | 2022-11-21 |
| 10194665004521 | A-dec | A-DEC, INC. | EFA | 2022-11-07 |
| 10194665004538 | A-dec | A-DEC, INC. | EFA | 2022-11-07 |
| D7166640010 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | EFA | 2022-10-27 |
| D7166640020 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | EFA | 2022-10-27 |
| D7166640030 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | EFA | 2022-10-27 |
| D7166640040 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | EFA | 2022-10-27 |
| D7166640050 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | EFA | 2022-10-27 |
| D7166640060 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | EFA | 2022-10-27 |
| D7166640070 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | EFA | 2022-10-27 |
| D7166640080 | SureFlex NiTi Rotary File | TULSA DENTAL PRODUCTS LLC | EFA | 2022-10-27 |