EDENTA
- Primary DI
- E3126503SO1
- Brand
- EDENTA
- Company
- EDENTA ETABLISSEMENT
- Model
- 6503SO
- Device description
- HeadMaster Passive-cylindrical
- Published
- 2022-02-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EBL | PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| E3126503SO1 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Root canal post kit | A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 448002915
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- 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
- true
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00810060227046 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2026-02-10 |
| 00810060225967 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2024-05-29 |
| 00810060225974 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2024-05-29 |
| 00810060225981 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2024-05-29 |
| 00810060225998 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2024-05-29 |
| 00810060226001 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2024-05-29 |
| 00810060226018 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2024-05-29 |
| 00810060226025 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2024-05-29 |
| 00810060226032 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2024-05-29 |
| 08800075620965 | OSUNG MND | OSUNG MND Co., Ltd. | EBL | 2024-03-06 |
| 08800075620972 | OSUNG MND | OSUNG MND Co., Ltd. | EBL | 2024-03-06 |
| 00810060225721 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | EBL | 2023-11-09 |
| 05060489370020 | Stabilok | FAIRFAX MEDICAL PRODUCTS LIMITED | EBL | 2023-04-16 |
| 00560489370020 | Stabilok | FAIRFAX MEDICAL PRODUCTS LIMITED | EBL | 2023-04-16 |
| 05060489370181 | Stabilok | FAIRFAX MEDICAL PRODUCTS LIMITED | EBL | 2023-04-16 |
| 05060489370174 | Stabilok | FAIRFAX MEDICAL PRODUCTS LIMITED | EBL | 2023-04-16 |
| 05060489370051 | Stabilok | FAIRFAX MEDICAL PRODUCTS LIMITED | EBL | 2023-04-16 |
| 05060489370204 | Stabilok drill | FAIRFAX MEDICAL PRODUCTS LIMITED | EBL | 2023-04-16 |
| 05060489370198 | Stabilok drill | FAIRFAX MEDICAL PRODUCTS LIMITED | EBL | 2023-04-16 |
| D2483801802 | Markley Threaded Wire .018 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D248380220 | Markley Threaded Wire .022 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D2483802500 | Markley Threaded Wire .025 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D2483802702 | Markley Threaded Wire .027 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D248380300 | Markley Threaded Wire .030 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D248380320 | Markley Threaded Wire .032 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D248380330 | Markley Threaded Wire .033 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D2483803501 | Markley Threaded Wire .035 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D2483803602 | Markley Threaded Wire .036 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D248380400 | Markley Threaded Wire .040 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |
| D2483804502 | Markley Threaded Wire .045 | HAGER WORLDWIDE, INC. | EBL | 2023-04-10 |