Data / Medical devices / South Korea / Vericom Co., Ltd.
Vericom Co., Ltd.: FDA-registered device maker in Chuncheon-Si Gangwon, South Korea, 20 510(k) clearances
Vericom Co., Ltd. is registered with the FDA (registration 3003449480) in Chuncheon-Si Gangwon, South Korea. It lists 16 device types. The FDA files 20 510(k) clearances under its listings, the newest dated May 11, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003449480
- Address
- 48, Toegyegongdan 1-gil, Chuncheon-Si Gangwon, South Korea, 24427
- Owner or operator
- VERICOM CO., LTD. (9046013)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- May 9, 2001
- Registered through
- 2026
- Brand names listed
- CUSTOM IMPRESSION TRAY RESIN, DENFIL, DENFIL FLOW, EAZI-APPLICATOR, EAZI-BRUSH, Eco-S, MAZIC D SG, SPACER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Manufacturer | accessdata.fda.gov |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | 1 | Manufacturer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | 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 |
|---|---|---|---|---|---|---|
| May 11, 2026 | K260805 | Dual Core | EBF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| September 19, 2025 | K252285 | Well-Root PT | KIF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| July 1, 2021 | K203672 | MAZIC Claro CAD and MAZIC Claro Press | EIH | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| August 21, 2020 | K193260 | U-Cem Premium & MAZIC Cem | EMA | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| December 20, 2017 | K170950 | Well-Root ST | KIF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| March 17, 2017 | K163346 | MAZIC Duro | EBF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| December 2, 2016 | K160377 | V-varnish Premium | LBH | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| November 3, 2016 | K152615 | Vonflex S | ELW | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| November 30, 2015 | K152518 | Vonflex S Putty | ELW | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| August 15, 2014 | K140966 | VONFLEX S BITE | ELW | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| November 10, 2010 | K103164 | VONFLEX HEAVY, VINFLEX LIGHT | ELW | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| October 26, 2010 | K103121 | ECO-S | EBC | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| May 6, 2009 | K091267 | VONFLEX PUTTY | ELW | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| April 21, 2009 | K090992 | WELL-PASTE | KIF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| February 6, 2008 | K080266 | WELL-PEX | KIF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| February 6, 2008 | K080265 | DENFIL ETCHANT-37 | EBF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| September 28, 2007 | K072069 | SPACER | EBF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| March 16, 2006 | K060637 | DENFIL FLOW | EBF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| January 3, 2005 | K043562 | BC PLUS | KLE | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| August 13, 2004 | K042124 | DENFIL | EBF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Resin
- All makers of Resin, Root Canal Filling
- All makers of Material, Impression
- All makers of Varnish, Cavity
- All makers of Material, Tooth Shade, Resin
- All makers of Powder, Porcelain
Updated May 11, 2026. 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.