| Primary Device ID | D7701609703 |
| NIH Device Record Key | 9398dc55-94b4-4179-9eb1-a56d1a1acb92 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FINAL CONICAL DRILL |
| Version Model Number | FK425-L-SW |
| Catalog Number | FK425-L-SW |
| Company DUNS | 433815198 |
| Company Name | SWEDEN & MARTINA SPA |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7701609703 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
[D7701609703]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-01 |
| Device Publish Date | 2025-07-24 |
| D7701609703 | FINAL CONICAL DRILL PRAMA D.4.25MM, LONG |
| D7701609693 | FINAL CONICAL DRILL PRAMA D.3.8MM, LONG |