Manufacturer registered with FDA
NIBEC Co Ltd
Jincheon, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 14
- 510(k) clearances
- 42013–2015
- Markets registered in
- 1250 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name NIBEC Co Ltd 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 | NIBEC Co Ltd | 4 clearances | 2013–2015 | Below |
| Canada | Health Canada | Registration holder | NIBEC CO., LTD. | 12 | 2015–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NIBEC CO., LTD. | 12 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Nibec Co Ltd | 6 | 2022–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NIBEC Co., LtdNIBEC Co., Ltd. | 6 | 2015–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | NIBEC Co., Ltd. | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NIBEC CO., LTD | 2 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | NIBEC Co., Ltd. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NIBEC Co., Ltd. | 2 | 2022–2022 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | NIBEC Co., Ltd. | 2 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | NIBEC Co., Ltd. | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | NIBEC Co., Ltd | 1 | 2025–2025 | 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 NIBEC Co Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | bone grafting material, animal sourceCreos XenogainCreos Xenogain CollagenInstradent XenograftNeodent XenoGraftOCS-BOCS-B CollagenRegenomerStraumann RegenomerStraumann XenoFlex 1 moreStraumann XenoGraft | 2011 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | GuidOssInstradent MembraneRegenoGide | 2014 |
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 NIBEC Co Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Dec 2015 | K150079 | Regenomer® Syringe, Regenomer® Plug, Regenomer® Block | NPM Animal Source Bone Grafting Material |
| 31 Jul 2015 | K142040 | OCS-B COLLAGEN | NPM Animal Source Bone Grafting Material |
| 5 Nov 2014 | K133507 | GUIDOSS | NPL Intraoral Animal Source Barrier |
| 16 Jan 2013 | K113246 | OCS-B | NPM Animal Source Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Nobel Biocare Services AG (2), Institut Straumann AG (1).
Also lists devices cleared under other names
NIBEC Co Ltd 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: Luitpold Pharmaceuticals, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Sep 2011 | K111816 | EQUIMATRIX | Luitpold Pharmaceuticals, Inc. | NPM Animal Source Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NIBEC CO LTDFDA reg. 3007679154 | Jincheon-gun Chungbuk, South Korea | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10038845). 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.