Manufacturer registered with FDA
Unicare Biomedical, Inc.
Laguna Hills, CA, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 91998–2015
- Markets registered in
- 945 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 9 markets
Where regulators' registries name Unicare Biomedical, 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 | Unicare Biomedical, Inc. | 9 clearances | 1998–2015 | Below |
| India | CDSCO | Registration holder | Unicare Biomedical | 17 | 2021–2021 | Pure Global AI |
| Colombia | INVIMA | Registration holder | UNICARE BIOMEDICAL, INC. | 6 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | UNICARE BIOMEDICAL, INC. | 6 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Unicare Biomedical Inc | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | UNICARE BIOMEDICAL, INC. | 5 | 2006–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Unicare Biomedical, Inc.UNICARE BIOMEDICAL, INC. | 3 | 2006–2017 | Pure Global AI |
| Canada | Health Canada | Registration holder | UNICARE BIOMEDICAL, INC. | 1 | 2000–2000 | Pure Global AI |
| Egypt | EDA | Manufacturer | Unicare Biomedical, Inc, | 1 | 2023–2023 | 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 Unicare Biomedical, 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 |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Cytoflex ResorbCytoflex TefguardUnigraft | 2007 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | CYTOFLEX MESH | 2006 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | Cytoflex Ti-Enforced MembranePerforated Cytoflex Ti-Enforced Membrane | 2017 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | CollaFlex | 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 Unicare Biomedical, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Nov 2015 | K151344 | Cytoflex Tefguard Ti-Enforced Membrane | NPK Intraoral Synthetic Barrier |
| 25 Nov 2009 | K092567 | MODIFICATION TO UNIGRAFT | LYC Synthetic Bone Grafting Material |
| 23 Mar 2009 | K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | LYC Synthetic Bone Grafting Material |
| 6 Aug 2002 | K021511 | CYTOFLEX MESH | JEY Bone Plate |
| 7 May 2002 | K020720 | OSSIFORM | LYC Synthetic Bone Grafting Material |
| 1 Oct 2001 | K012144 | CYTOFLEX | LYC Synthetic Bone Grafting Material |
| 9 Jan 2001 | K003457 | UNIGRAFT | LYC Synthetic Bone Grafting Material |
| 27 Jan 2000 | K993784 | UNIGRAFT | LYC Synthetic Bone Grafting Material |
| 20 Oct 1998 | K982699 | UNIGRAFE | LYC Synthetic Bone Grafting Material |
Also lists devices cleared under other names
Unicare Biomedical, 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: Sk Bioland Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Oct 2020 | K200623 | OssGuide | Sk Bioland Co., Ltd. | NPL Intraoral Animal Source Barrier |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| UNICARE BIOMEDICAL, INC.FDA reg. 2032542 | Laguna Hills, CA, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9034652). 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.