Power Dental U.S.A., Inc.
- Primary DI
- D943N2083
- Brand
- Power Dental U.S.A., Inc.
- Company
- Power Dental U.S.A. Inc.
- Model
- N2083
- Catalog number
- N2083
- Device description
- BONE CRUSHER (MORSELIZER)
- Published
- 2021-06-20
- 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
Related Records
Contact Domains
mydentalusa.comProduct Codes
| Code | Name |
|---|---|
| LYS | Bone mill |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LYS | Bone Mill | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D943N2083 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Manual bone mill | A manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | |
|---|---|
| +1(815)363-8003 | info@mydentalusa.com |
Regulatory Flags
- DUNS number
- 081305064
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- 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
- true
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D943ORCAA0 | Power Dental USA | ORCAA | ORCAA | 2021-06-20 |
| D94367350 | Power Dental USA | 6735 | 6735 | 2021-06-20 |
| D94367380 | Power Dental USA | 6738 | 6738 | 2021-06-20 |
| D94367390 | Power Dental USA | 6739 | 6739 | 2021-06-20 |
| D94367410 | Power Dental USA | 6741 | 6741 | 2021-06-20 |
| D94367430 | Power Dental USA | 6743 | 6743 | 2021-06-20 |
| D9431007E0 | Power Dental USA | 1007E | 1007E | 2021-07-13 |
| D94315240 | Power Dental USA | 1524 | 1524 | 2021-06-20 |
| D94335090 | Power Dental USA | 3509 | 3509 | 2021-06-20 |
| D9434826XAS0 | Power Dental USA | 4826XAS | 4826XAS | 2021-07-13 |
| D94362100 | Power Dental USA | 6210 | 6210 | 2021-06-20 |
| D94364470 | Power Dental USA | 6447 | 6447 | 2022-01-08 |
| D943813050 | Power Dental USA | 8130-5 | 8130-5 | 2021-07-13 |
| D943DCAM0 | Power Dental USA | DCAM | DCAM | 2021-07-13 |
| D943DCAM30 | Power Dental USA | DCAM3 | DCAM3 | 2021-07-13 |
| D943KIM10 | Power Dental USA | KIM-1 | KIM-1 | 2022-07-12 |
| D943KIM120 | Power Dental USA | KIM-12 | KIM-12 | 2022-07-12 |
| D943KIM20 | Power Dental USA | KIM-2 | KIM-2 | 2022-07-12 |
| D943KIM240 | Power Dental USA | KIM-24 | KIM-24 | 2021-07-13 |
| D943KIM30 | Power Dental USA | KIM-3 | KIM-3 | 2022-07-12 |
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| 00889024675360 | Z1™ Hip System | Zimmer, Inc. | LYS | 2024-09-09 |
| B504BMBM2100 | Medtronic | Provision | LYS | 2024-06-11 |
| 04047844121368 | DIPLOMAT | SIGNUS Medizintechnik GmbH | LYS | 2024-06-05 |
| 00842517106253 | Karl Schumacher | Karl Schumacher Dental, LLC | LYS | 2024-02-27 |
| 10603295516378 | NA | DEPUY ORTHOPAEDICS, INC. | LYS | 2024-01-15 |
| 00614950031252 | ACE | ACE SURGICAL SUPPLY CO., INC. | LYS | 2023-12-05 |
| 00888118142924 | BONE MILL | KLS-Martin L.P. | LYS | 2023-11-22 |
| 00888118142931 | BONE MILL | KLS-Martin L.P. | LYS | 2023-11-22 |
| 00888118142948 | BONE MILL | KLS-Martin L.P. | LYS | 2023-11-22 |
| 00888118142955 | BONE MILL | KLS-Martin L.P. | LYS | 2023-11-22 |
| 00888118142962 | BONE MILL | KLS-Martin L.P. | LYS | 2023-11-22 |
| 00841336103399 | Salvin Bone Morselizer With Titanium Knurled Surfaces | Salvin Dental Specialties, Inc. | LYS | 2023-08-10 |
| 00841336103504 | Salvin Titanium Bone Cruncher™ | Salvin Dental Specialties, Inc. | LYS | 2023-08-10 |
| 00888118142597 | BONE MILL | KLS-Martin L.P. | LYS | 2023-07-04 |
| 00888118142603 | BONE MILL | KLS-Martin L.P. | LYS | 2023-07-04 |
| 00888118142610 | BONE MILL | KLS-Martin L.P. | LYS | 2023-07-04 |
| 00888118142627 | BONE MILL | KLS-Martin L.P. | LYS | 2023-07-04 |
| 00888118142634 | BONE MILL | KLS-Martin L.P. | LYS | 2023-07-04 |
| 00888118142641 | BONE MILL | KLS-Martin L.P. | LYS | 2023-07-04 |
| 00888118142658 | BONE MILL | KLS-Martin L.P. | LYS | 2023-07-04 |
| 00190776264055 | Avalign | AVALIGN TECHNOLOGIES, INC. | LYS | 2023-06-23 |
| 08720254007816 | Sterilization tray NBM | Spierings Orthopaedics B.V. | LYS | 2023-06-20 |
| 08720254007823 | Housing | Spierings Orthopaedics B.V. | LYS | 2023-06-20 |
| 08720254007830 | Push Block | Spierings Orthopaedics B.V. | LYS | 2023-06-20 |
| 08720254007847 | Handle | Spierings Orthopaedics B.V. | LYS | 2023-06-20 |
| 08720254007854 | Screw nut | Spierings Orthopaedics B.V. | LYS | 2023-06-20 |
| 08720254007861 | Milling Drum Extra Extra Extra Fine | Spierings Orthopaedics B.V. | LYS | 2023-06-20 |