Health-Tec/DHP K-Files
- Primary DI
- D773334KK30601
- Brand
- Health-Tec/DHP K-Files
- Company
- Dental Health Products Inc
- Model
- 334-KK3060
- Catalog number
- 334-KK3060
- Device description
- Health-Tec/DHP K-Files 60-31mm Blue 6/pkg
- Published
- 2022-10-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- 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 |
|---|
| D773334KK30601 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Manual endodontic file/rasp, reusable | A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. 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 an endodontic reamer. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 623191194
- Device count
- 1
- 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
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| D7735901000721 | DHP/Health-Tec Sterilization Tape | 590-100072 | 590-100072 | 2023-03-24 |
| D7735901000821 | DHP/Health-Tec Sterilization Tape | 590-100082 | 590-100082 | 2023-03-24 |
| D7736001000320 | DHP/Health-Tec Sterilization Pouches | 600-100032 | 600-100032 | 2023-03-23 |
| D7736001000420 | DHP/Health-Tec Sterilization Pouches | 600-100042 | 600-100042 | 2023-03-23 |
| D7736001000520 | DHP/Health-Tec Sterilization Pouches | 600-100052 | 600-100052 | 2023-03-23 |
| D7736001000620 | DHP/Health-Tec Sterilization Pouches | 600-100062 | 600-100062 | 2023-03-23 |
| D7736001000720 | DHP/Health-Tec Sterilization Pouches | 600-100072 | 600-100072 | 2023-03-23 |
| D7736001000820 | DHP/Health-Tec Sterilization Pouches | 600-100082 | 600-100082 | 2023-03-23 |
| D7736001000920 | DHP/Health-Tec Sterilization Pouches | 600-100092 | 600-100092 | 2023-03-23 |
| D7736001001020 | DHP/Health-Tec Sterilization Pouches | 600-100102 | 600-100102 | 2023-03-23 |
| D7736001001120 | DHP/Health-Tec Sterilization Pouches | 600-100112 | 600-100112 | 2023-03-23 |
| D773970100010 | Health-Tec/DHP Disposable Prophy Angles | 970-10001 | 970-10001 | 2022-11-28 |
| D773970100020 | Health-Tec/DHP Disposable Prophy Angles | 970-10002 | 970-10002 | 2022-11-28 |
| D7739705220140 | Health-Tec/DHP Disposable Prophy Angles | 970-522014 | 970-522014 | 2022-11-28 |
| D773970522140 | Health-Tec/DHP Disposable Prophy Angles | 970-522114 | 970-522114 | 2022-11-28 |
| D7739705224140 | Health-Tec/DHP Disposable Prophy Angles | 970-522414 | 970-522414 | 2022-11-28 |
| D7739705225140 | Health-Tec/DHP Disposable Prophy Angles | 970-522514 | 970-522514 | 2022-11-28 |
| D773930100060 | Health-Tec/DHP PSP Barrier Envelopes | 930-10006 | 930-10006 | 2022-11-14 |
| D773930HTBWT0 | Health-Tec/DHP Bite Wing Tabs | 930-HTBWT | 930-HTBWT | 2022-11-14 |
| D773800100020 | Health-Tec/DHP Matrix Bands | 800-10002 | 800-10002 | 2022-11-10 |
Other Devices Sharing Product Codes