Data / Medical devices / South Korea / Nibec Co Ltd
Nibec Co Ltd: FDA-registered device maker in Jincheon-gun Chungbuk, South Korea, 5 510(k) clearances
Nibec Co Ltd is registered with the FDA (registration 3007679154) in Jincheon-gun Chungbuk, South Korea. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 10, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007679154
- Address
- Iwol Electricity-electronic Agro-Industrial Complex 116 Bamdi-gil, Iwol-myeon, Jincheon-gun Chungbuk, South Korea, 27816
- Owner or operator
- NIBEC Co Ltd (10038845)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 16, 2011
- Registered through
- 2026
- Brand names listed
- Creos Xenogain, Creos Xenogain Collagen, GuidOss, Instradent Membrane, Instradent Xenograft, Neodent XenoGraft, OCS-B, OCS-B Collagen and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 2 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 10, 2015 | K150079 | Regenomer® Syringe, Regenomer® Plug, Regenomer® Block | NPM | Substantially Equivalent | Nibec Co., Ltd. | accessdata.fda.gov |
| July 31, 2015 | K142040 | OCS-B COLLAGEN | NPM | Substantially Equivalent | Nibec Co., Ltd. | accessdata.fda.gov |
| November 5, 2014 | K133507 | GUIDOSS | NPL | Substantially Equivalent | Nibec Co., Ltd. | accessdata.fda.gov |
| January 16, 2013 | K113246 | OCS-B | NPM | Substantially Equivalent | Nibec Company, Limited | accessdata.fda.gov |
| September 29, 2011 | K111816 | EQUIMATRIX | NPM | Substantially Equivalent | Luitpold Pharmaceuticals, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 10, 2015. 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.