Manufacturer registered with FDA
Oco Biomedical
Albuquerque, NM, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 10
- 510(k) clearances
- 42008–2013
- Markets registered in
- 440 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Oco Biomedical as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Oco Biomedical | 4 clearances | 2008–2013 | Below |
| Canada | Health Canada | Registration holder | OCO BIOMEDICAL, INC. | 36 | 2010–2018 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OCO BIOMEDICAL, INC. | 3 | 2007–2013 | Pure Global AI |
| South Korea | MFDS | Manufacturer | OCO Biomedical, INC. | 1 | 2008–2008 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Oco Biomedical currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | IMMEDIATE STABLIZING IMPLANT (ISI)SMALL DIAMETER IMPLANT (SDI)TSI / ERI; ENGAGE / ENGAGE PLUS3 DENTAL IMPLANT | 2021 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | DENTAL INTRAORAL DRILL | 2001 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | DENTAL INSTRUMENTS | 2024 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | DENTAL DEPTH GAUGE | 2001 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | DENTAL BUR | 2001 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DENTAL IMPLANT ACCESSIRUES | 2024 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | TSI / ERI; ENGAGE / ENGAGE PLUS | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Oco Biomedical as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Apr 2013 | K122198 | 6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 16 Mar 2012 | K110337 | UNIVERSAL MAXILLARY MOLAR | DZE Root-Form Endosseous Implant |
| 14 Sep 2009 | K090174 | TSI; ERI | DZE Root-Form Endosseous Implant |
| 30 May 2008 | K080115 | I-MINI DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
Also lists devices cleared under other names
Oco Biomedical lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: O Co., Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 Dec 2003 | K033392 | IMMEDIATE STABILIZING IMPLANT (ISI) | O Co., Inc. | DZE Root-Form Endosseous Implant |
| 10 Apr 2002 | K011524 | IMMEDIATE STABILIZING DEVICE (ISD) | O Co., Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OCO BIOMEDICALFDA reg. 1627417 | ALBUQUERQUE, NM, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1627417). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.