Data / Medical devices / United States / Oco Biomedical
Oco Biomedical: FDA-registered device maker in Albuquerque, NM, United States, 4 510(k) clearances
Oco Biomedical is registered with the FDA (registration 1627417) in Albuquerque, NM, United States. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 14, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1627417
- Address
- 9550 San Mateo Blvd NE Ste C, Albuquerque, NM, United States, 87113
- Owner or operator
- OCO BIOMEDICAL (1627417)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 19, 2001
- Registered through
- 2026
- Brand names listed
- 3 DENTAL IMPLANT, DENTAL BUR, DENTAL DEPTH GAUGE, DENTAL IMPLANT ACCESSIRUES, DENTAL INSTRUMENTS, DENTAL INTRAORAL DRILL, IMMEDIATE STABLIZING IMPLANT (ISI), SMALL DIAMETER IMPLANT (SDI) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 14, 2009 | K090174 | TSI; ERI | DZE | Substantially Equivalent | Oco Biomedical | accessdata.fda.gov |
| May 30, 2008 | K080115 | I-MINI DENTAL IMPLANT | DZE | Substantially Equivalent | Oco Biomedical | accessdata.fda.gov |
| December 10, 2003 | K033392 | IMMEDIATE STABILIZING IMPLANT (ISI) | DZE | Substantially Equivalent | O Co., Inc. | accessdata.fda.gov |
| April 10, 2002 | K011524 | IMMEDIATE STABILIZING DEVICE (ISD) | DZE | Substantially Equivalent | O Co., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bur, Dental
- All makers of Implant, Endosseous, Root-Form
- All makers of Drill, Dental, Intraoral
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Instruments, Dental Hand
Updated September 14, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.