Manufacturer registered with FDA
Bioplate, Inc.
Placentia, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 17 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 10
- 510(k) clearances
- 172000–2008
- Markets registered in
- 9190 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Bioplate, Inc. 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 | Bioplate, Inc. | 17 clearances | 2000–2008 | Below |
| Canada | Health Canada | Registration holder | BIOPLATE INC | 148 | 1999–2009 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Bioplate, Inc. | 14 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Bioplate, Inc.BIOPLATE, INC. · BIOPLATE.INC · +2 | 13 | 1998–2009 | Pure Global AI |
| Australia | TGA | Manufacturer | Bioplate Inc | 4 | 2005–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BIOPLATE INC. | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BIOPLATE, INCBIOPLATE INC. | 3 | 2005–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIOPLATE, INC. | 3 | 2001–2016 | Pure Global AI |
| China | NMPA | Registration holder | 佰普勒有限公司Bioplate, Inc. | 1 | — | 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 Bioplate, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | Bioplate Rigid Fixation BoneModified Sterile Plate & Screw kit configurations for use with Bioplate Titanium Fixation SystemPlating SystemRigid Fixation Bone Plating SystemScrews for Rigid Fixation BoneThe Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryThe Bioplate Rigid Fixation bone plating system for Craniomaxillofacial surgeryThe Bioplate Rigid Fixation SystemThe Titanium Fixation SystemTitanium Fixation System | 2008 |
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 Bioplate, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Oct 2008 | K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM | JEY Bone Plate |
| 27 Jul 2005 | K051845 | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM | JEY Bone Plate |
| 28 Apr 2003 | K031028 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 8 Apr 2003 | K030806 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 4 Dec 2002 | K023810 | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 22 Nov 2002 | K023665 | MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 6 Sep 2002 | K022890 | MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 19 Jul 2002 | K022033 | STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM | JEY Bone Plate |
| 26 Jun 2002 | K021684 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 7 Dec 2001 | K013055 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | JEY Bone Plate |
| 28 Nov 2001 | K012908 | BIOPLATE RESORBABLE BONE SCREW | DZL Intraosseous Fixation Screw |
| 20 Nov 2001 | K012910 | THE BIOPLATE MANDIBLE FIXATION SYSTEM | JEY Bone Plate |
| 14 May 2001 | K011380 | MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | JEY Bone Plate |
| 26 Jan 2001 | K002426 | THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 24 Jan 2001 | K994060 | THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE | JEY Bone Plate |
| 5 Oct 2000 | K002879 | MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | JEY Bone Plate |
| 21 Jul 2000 | K001530 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | JEY Bone Plate |
Also lists devices cleared under other names
Bioplate, Inc. 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: Biomedics (5).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Nov 1999 | K992330 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Biomedics | JEY Bone Plate |
| 9 Jun 1998 | K980983 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Biomedics | JEY Bone Plate |
| 25 Sep 1997 | K972463 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | Biomedics | JEY Bone Plate |
| 29 Sep 1995 | K953273 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM | Biomedics | JEY Bone Plate |
| 6 Jan 1995 | K943071 | THE TITANIUM FIXATION SYSTEM | Biomedics | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOPLATE, INC.FDA reg. 2029447 | Placentia, CA, United States | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9016123). 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.