FDA Registration
Active
🇪🇸 Spain
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
Reg #: 3004417597
·
FEI: 3004417597
·
Expires 2026
Products
33
Proprietary Names
1
Establishment Types
4
Classifications
33
Registration Details
- Registration Name
- B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
- Registration Number
- 3004417597
- FEI Number
- 3004417597
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LEONARDO DA VINCI 14
- City
- Miñano Alava
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K053355
Owner / Operator
- Firm Name
- B.T.I. BIOTECHNOLOGY
- Operator Number
- 9052086
- Address
- LEONARDO DA VINCI 14, PARQUE TECNOLOGICO DE ALAVA
- City
- MIÑANO
- State
- Alava
- Postal Code
- 01510
- Country
- ES
US Agent
- Business Name
- PAXMED INTERNATIONAL, LLC
- Contact Name
- Floyd Larson
- Address
- 1925 Palomar Oaks Way Ste 210
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
- [email protected]
- Phone
- 858 7921235
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2009-12-03 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2024-10-29 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2017-06-30 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2014-05-08 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2015-07-22 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2005-01-31 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2005-01-31 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2009-12-03 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2004-08-17 |
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2016-01-13 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2015-06-17 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2020-07-13 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2017-01-31 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2005-12-07 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2015-12-29 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2023-09-13 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2014-05-08 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2005-01-31 |
| Curette, Periodontic | EMS | Class 1 | Dental | No | 2017-06-30 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2005-01-31 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2026-06-16 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2026-06-16 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2026-06-16 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2005-01-31 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2005-01-31 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2005-01-31 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2005-01-31 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2005-01-31 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2010-05-06 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2017-06-30 |
| Filter, Conduction, Anesthetic | BSN | Class 2 | Anesthesiology | No | 2020-08-27 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2005-01-31 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2004-05-26 |
Proprietary Names
INPESPA1
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility