Dental Device Guide
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Manufacturer registered with FDA

Vericom Co., Ltd.

Anyang-si, South Korea. Lists 16 dental device types with FDA across 1 registered establishment, and holds 20 510(k) clearances as applicant.

FDA owner/operator9046013ManufacturerRepacker / relabeler2 clearances in five years
Device types listed
16
Brands and models
12
510(k) clearances
202004–2026
Markets registered in
14167 registrations outside the US
Establishments
1South Korea
2004: 12005: 12006: 12007: 12008: 22009: 22010: 22014: 12015: 12016: 22017: 22020: 12021: 12025: 12026: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 14 markets

Where regulators' registries name Vericom Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 16 device types listedBrazil: 35 registrationsTaiwan: 31 registrationsCosta Rica: 24 registrationsSerbia: 18 registrationsSaudi Arabia: 13 registrationsAustralia: 10 registrationsColombia: 10 registrationsChina: 9 registrationsCanada: 5 registrationsEgypt: 4 registrationsUnited Kingdom: 4 registrationsIsrael: 2 registrationsPeru: 2 registrations
RegisteredHome: South KoreaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerVericom Co., Ltd.20 clearances2004–2026Below
BrazilANVISAManufacturerVERICOM CO., LTD.352020–2024Pure Global AI
TaiwanTFDAManufacturerVERICOM CO., LTD.312005–2025Pure Global AI
Costa RicaMinisterio de SaludManufacturerVERICOM Co.,LtdVERICOM Co., Ltd.24—Pure Global AI
SerbiaALIMSManufacturerVericom Co., Ltd182023–2025Pure Global AI
Saudi ArabiaSFDAManufacturerVericom Co., Ltd13—Pure Global AI
AustraliaTGAManufacturerVericom Co Ltd102012–2025Pure Global AI
ColombiaINVIMAManufacturerVERICOM CO., LTD10—Pure Global AI
ChinaNMPARegistration holder倍丽康有限公司VERICOM CO.,LTD倍丽康有限公司Vericom Co., Ltd · 倍丽康有限公司VERICOM CO., LTD · +29—Pure Global AI
CanadaHealth CanadaRegistration holderVERICOM CO., LTD.52009–2010Pure Global AI
EgyptEDAManufacturerVericom Co., Ltd.,VERICOM CO., LTD., · Vericom Co., Ltd,42025–2026Pure Global AI
United KingdomMHRAManufacturerVericom Co., Ltd.4—Pure Global AI
IsraelAMARManufacturerVERICOM CO., LTD.2—Pure Global AI
PeruDIGEMIDManufacturerVERICOM CO., LTD.VERICOM, Co., Ltd.22024–2025Pure 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 Vericom Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
DENFILDENFIL FLOWSPACER
2005
Impression MaterialELW · Class 2Impression materialsMaker
Vonflex Heavy, Vonflex Light
2009
Root Canal Filling ResinKIF · Class 2Root canal filling materialsMaker
Well-PasteWell-Pex
2008
Dental NeedleDZM · Class 1Dental needles & syringesLister—2013
Pit and Fissure Sealant and ConditionerEBC · Class 2Sealants & varnishesMaker
Eco-S
2010
Resin Impression Tray MaterialEBH · Class 1Impression traysMaker
CUSTOM IMPRESSION TRAY RESIN
2001
Abrasive DiskEHJ · Class 1Polishing & prophylaxisMaker
EAZI-BRUSH
2001
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker—2021
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker—2001
Root Canal Endodontic PreparerEKQ · Class 1Endodontic filesMaker
WELL-PREP ROOT CANAL CLEANSER
2007
Posterior with Metal Insert Artificial TeethELJ · Class 1—Maker—2026
Dental CementEMA · Class 2Dental cementsMaker—2020
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsMaker—2007
Resin ApplicatorKXR · Class 1—Maker
EAZI-APPLICATOR
2005
Cavity VarnishLBH · Class 2Sealants & varnishesMaker—2017
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
MAZIC D SG
2001

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 Vericom Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
11 May 2026K260805Dual CoreEBF Resin Tooth Shade Material
19 Sep 2025K252285Well-Root PTKIF Root Canal Filling Resin
1 Jul 2021K203672MAZIC Claro CAD and MAZIC Claro PressEIH Porcelain Powder
21 Aug 2020K193260U-Cem Premium & MAZIC CemEMA Dental Cement
20 Dec 2017K170950Well-Root STKIF Root Canal Filling Resin
17 Mar 2017K163346MAZIC DuroEBF Resin Tooth Shade Material
2 Dec 2016K160377V-varnish PremiumLBH Cavity Varnish
3 Nov 2016K152615Vonflex SELW Impression Material
30 Nov 2015K152518Vonflex S PuttyELW Impression Material
15 Aug 2014K140966VONFLEX S BITEELW Impression Material
10 Nov 2010K103164VONFLEX HEAVY, VINFLEX LIGHTELW Impression Material
26 Oct 2010K103121ECO-SEBC Pit and Fissure Sealant and Conditioner
6 May 2009K091267VONFLEX PUTTYELW Impression Material
21 Apr 2009K090992WELL-PASTEKIF Root Canal Filling Resin
6 Feb 2008K080266WELL-PEXKIF Root Canal Filling Resin
6 Feb 2008K080265DENFIL ETCHANT-37EBF Resin Tooth Shade Material
28 Sep 2007K072069SPACEREBF Resin Tooth Shade Material
16 Mar 2006K060637DENFIL FLOWEBF Resin Tooth Shade Material
3 Jan 2005K043562BC PLUSKLE Resin Tooth Bonding Agent
13 Aug 2004K042124DENFILEBF Resin Tooth Shade Material

Some of these clearances are listed with FDA today by another company: Sure Dent Corporation (2), Handae Chemical Co., Ltd (1), HEXA Dental (1), B&L Biotech Co., Ltd. (1).

Registered establishments

EstablishmentLocationWhat it does
VERICOM CO., LTD.FDA reg. 3003449480Chuncheon-Si Gangwon, South KoreaManufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9046013). 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.