FDA Registration
Active
🇺🇸 United States
OCO BIOMEDICAL
Reg #: 1627417
·
FEI: 1627417
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- OCO BIOMEDICAL
- Registration Number
- 1627417
- FEI Number
- 1627417
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9550 San Mateo Blvd NE Ste C
- City
- ALBUQUERQUE
- State
- NM
- ZIP
- 87113
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080115
Owner / Operator
- Firm Name
- OCO BIOMEDICAL
- Operator Number
- 1627417
- Address
- 9550 San Mateo Blvd NE, SUITE C
- City
- Albuquerque
- State
- NM
- Postal Code
- 87113
- Country
- US
- Correspondent
- Vincent D'Alise
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2021-03-15 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2021-03-15 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2001-11-19 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2001-11-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2024-02-20 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2001-11-19 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2024-02-20 |
Proprietary Names
3 DENTAL IMPLANT
TSI / ERI; ENGAGE / ENGAGE PLUS
DENTAL BUR
DENTAL DEPTH GAUGE
IMMEDIATE STABLIZING IMPLANT (ISI)
DENTAL INSTRUMENTS
DENTAL INTRAORAL DRILL
SMALL DIAMETER IMPLANT (SDI)
DENTAL IMPLANT ACCESSIRUES
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device