ROSEN SCREW RS-SCREW1.4LT5W
GUDID 07290109747583
50 X Wave Rosen Screw M1.4 (T5) Long
BHI IMPLANTS LTD
Dental implant suprastructure, permanent, preformed| Primary Device ID | 07290109747583 |
| NIH Device Record Key | 568891e5-c57e-4ec3-a66f-1eb04ea66b2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROSEN SCREW |
| Version Model Number | 1 |
| Catalog Number | RS-SCREW1.4LT5W |
| Company DUNS | 600330916 |
| Company Name | BHI IMPLANTS LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com | |
| Phone | +1818-903-6736 |
| Rosenscrew@gmail.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290109747583 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103280
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
[07290109747583]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-28 |
| Device Publish Date | 2024-06-20 |
On-Brand Devices [ROSEN SCREW]
| 07290109743189 | 50 X Rosen Screw (M1.6) |
| 07290109743172 | 50 X Rosen Screw (M1.72) |
| 07290109743165 | 50 X Rosen Screw (M1.4) |
| 07290109747439 | 50 X LH Rosen Screw 1.4 (Torx 6) |
| 07290109747422 | 50 X SH Rosen Screw 1.4 (Torx 6) |
| 07290109747484 | 50 X Rosen Screw 1.4 Long |
| 07290109747668 | 50 X SH Rosen Screw UNF 1.72 (T6) |
| 07290109747651 | 50 X SH Rosen Screw M1.6 (T6) |
| 07290109747644 | 50 X Wave Rosen Screw UNF 1.72 (T5) |
| 07290109747637 | 50 X Rosen Screw UNF 1.72 (T5) |
| 07290109747620 | 50 X Wave Rosen Screw M1.6 (T5) |
| 07290109747613 | 50 X Rosen Screw M1.6 (T5) |
| 07290109747606 | 50 X Wave Rosen Screw M1.4 (T5) |
| 07290109747590 | 50 X Rosen Screw M1.4 (T5) |
| 07290109747583 | 50 X Wave Rosen Screw M1.4 (T5) Long |
| 07290109747576 | 50 X Rosen Screw M1.4 (T5) Long |
Trademark Results [ROSEN SCREW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROSEN SCREW 90667711 not registered Live/Pending |
Rosen, Dan 2021-04-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.