| 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 |