Dental Device Guide
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Manufacturer registered with FDA

Dentium USA

Cypress, CA, United States. Lists 7 dental device types with FDA across 2 registered establishments, and holds 23 510(k) clearances as applicant.

FDA owner/operator9063757Manufacturer1 clearance in five years
Device types listed
7
Brands and models
1,737
510(k) clearances
232004–2022
Markets registered in
12414 registrations outside the US
Establishments
2South Korea, United States
2004: 12006: 42007: 12010: 12012: 22014: 12016: 42017: 32018: 22019: 12020: 22022: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 12 markets

Where regulators' registries name Dentium USA as the manufacturer or the registration holder of a device.

All markets
United States: 7 device types listedCanada: 173 registrationsSaudi Arabia: 134 registrationsChina: 33 registrationsTaiwan: 29 registrationsSerbia: 17 registrationsAustralia: 11 registrationsColombia: 10 registrationsEuropean Union: 2 registrationsIsrael: 2 registrationsSouth Korea: 2 registrationsEgypt: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDentium USA23 clearances2004–2022Below
CanadaHealth CanadaRegistration holderDENTIUM CO., LTD.DENTIUM USA1732007–2019Pure Global AI
Saudi ArabiaSFDAManufacturerDENTIUM CO., LTD.134—Pure Global AI
ChinaNMPARegistration holder登腾株式会社Dentium Co., Ltd.登腾株式会社Dentium Co.,Ltd. · 登腾株式会社 Dentium Co.,Ltd. · +133—Pure Global AI
TaiwanTFDAManufacturerDENTIUM CO., LTD.Dentium Co., Ltd. · DENTIUM USA292006–2023Pure Global AI
SerbiaALIMSManufacturerDentium Co., Ltd172026–2026Pure Global AI
AustraliaTGAManufacturerDentium Co Ltd112007–2024Pure Global AI
ColombiaINVIMARegistration holderDENTIUM CO LTDDENTIUM CO. LTD.10—Pure Global AI
European UnionEUDAMEDManufacturerDentium Co., Ltd.2—Pure Global AI
IsraelAMARManufacturerDentium Co., Ltd.2—Pure Global AI
South KoreaMFDSManufacturerDentium USA22011–2016Pure Global AI
EgyptEDAManufacturerDentium co,LTD,12026–2026Pure 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 Dentium USA currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
AAB154515HAAB154515HEAAB154515HLAAB154515HTAAB154515NAAB154515NEAAB154515NGAAB154515NLAAB154515NTAAB154525H
843 more
AAB154525HEAAB154525HGAAB154525HLAAB154525HTAAB154525NAAB154525NEAAB154525NLAAB154525NTAAB154535HAAB154535HEAAB154535HGAAB154535HLAAB154535HTAAB154535NAAB154535NEAAB154535NLAAB154535NTAAB154540HLAAB154540NLAAB155515HAAB155515HEAAB155515HGAAB155515HLAAB155515HTAAB155515NAAB155515NEAAB155515NLAAB155515NTAAB155520HLAAB155520NLAAB155525HAAB155525HEAAB155525HGAAB155525HLAAB155525HTAAB155525NAAB155525NEAAB155525NLAAB155525NTAAB155535HAAB155535HEAAB155535HLAAB155535HTAAB155535NAAB155535NEAAB155535NLAAB155535NTAAB155540HLAAB155540NLAAB254515HAAB254515HEAAB254515HLAAB254515HTAAB254515NAAB254515NEAAB254515NLAAB254515NTAAB254525HAAB254525HEAAB254525HGAAB254525HTAAB254525NAAB254525NEAAB254525NLAAB254525NTAAB254535HAAB254535HEAAB254535HGAAB254535HTAAB254535NAAB254535NEAAB254535NLAAB254535NTAAB255515HAAB255515HEAAB255515HLAAB255515HTAAB255515NAAB255515NEAAB255515NLAAB255525HAAB255525HEAAB255525HLAAB255525HTAAB255525NAAB255525NEAAB255525NLAAB255525NTAAB255535HAAB255535HEAAB255535HLAAB255535HTAAB255535NAAB255535NEAAB255535NTASA4510HASA4510NASA45151018HASA45151018HTASA45151018NASA45151018NTASA451510RHASA451510RNASA45152018HTASA45152018NASA45152018NTASA451520RHASA451520RNASA451530RHASA451530RNASA452010RHASA452010RNASA452020RHASA452020RNASA452030RHASA452030RNASA4520HASA4520NASA45301018HASA45301018HTASA45301018NASA45301018NTASA453010RHASA453010RNASA45302018HTASA45302018NASA45302018NTASA453020RHASA453020RNASA453030RHASA453030RNASA4530HASA4530NASA5510HASA5510NASA551510RHASA551510RNASA55151518HASA55151518HTASA55151518N
2007
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker
BNO1BNO2BPF2BPF3FX3408MLCFX3410MLCFX3412MLCFX3414MLCFX3608SWCFX3610SWC
237 more
FX3612SWCFX3614SWCFX3808MLCFX3810MLCFX3812MLCFX3814MLCFX4008SWCFX4010SWCFX4012SWCFX4014SWCFX4308MLCFX4310MLCFX4312MLCFX4314MLCFX4508SWCFX4510SWCFX4512SWCFX4514SWCFX4808MLCFX4810MLCFX4812MLCFX4814MLCFX5008SWCFX5010SWCFX5012SWCFX5014SWCFX6008SWCFX6010SWCFX6012SWCFX7008SWCFX7010SWCFX7012SWCFXS3607BCFXS3608CFXS3610CFXS3612CFXS3614CFXS4007BCFXS4008CFXS4010CFXS4012CFXS4014CFXS4507BCFXS4507CFXS4508CFXS4510CFXS4512CFXS4514CFXS5007BCFXS5007CFXS5008CFXS5010CFXS5012CFXS5014CFXS6007CFXS6008CFXS6010CFXS6012CFXS7007CFXS7008CFXS7010CFXS7012CGAAB153710ARGAAB153710ASGAAB153720ARGAAB153720ASGAAB153730ARGAAB153730ASGAAB154310ARGAAB154310ASGAAB154320ARGAAB154320ASGAAB154330ARGAAB154330ASGAAB155510ARGAAB155510ASGAAB155520ARGAAB155520ASGAAB155530ARGAAB155530ASGAAB253710ARGAAB253710ASGAAB253720ARGAAB253720ASGAAB253730ARGAAB253730ASGAAB254310ARGAAB254310ASGAAB254320ARGAAB254320ASGAAB254330ARGAAB254330ASGAAB255510ARGAAB255510ASGAAB255520ARGAAB255520ASGAAB255530ARGAAB255530ASGAOB4310AGAOB432010ARGAOB432010ASGAOB432020ARGAOB432020ASGAOB432030ARGAOB432030ASGAOB4320AGAOB4330AGAOC5010AGAOC5020AGAOC5030AGAOS5010AGAOS5020AGAOS5030AGAOSC1619GASC1619GBAB3510GBAB3520GBAB3530GBAB3540GBAB3550GBHA3135GBHA3605GBHA3620GCMAB30RSGCMAB30SSGCS30GCS36GDAB3705ARGDAB3705ASGDAB3710ARGDAB3710ASGDAB3720ARGDAB3720ASGDAB3730ARGDAB3730ASGDAB3740ARGDAB3740ASGDAB3750ARGDAB3750ASGDAB4310AR
2007
Orthodontic Band DriverECT · Class 1Dental hand instrumentsMaker
CRG45LCRG55LCRG65LCRHCRMFFA28HFFA28WFFA30WFMS49FOS49
2 more
FSMHSSOS30
2004
Dental Instrument Depth GaugeEIL · Class 1Dental hand instrumentsMaker
XDGL
2008
Preformed CrownELZ · Class 1—Maker
TSA2-FSTSTR-FS
2015
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker
RS142435RS203235RS263635XOCKXOCKBXOF20A1XOF20B1XOF34A1XOF34B1XOF38A1
10 more
XOF38B1XOF43A1XOF43B1XOF48A1XOF48B1XOFBKXOFKXOFKBXRA3917XRSK
2004
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
ASAHBANLBOSCAN45LLCAN45SLCAN55LLCAN55SLCAN65LLCAN65SLCBC45BL(1)
592 more
CBC45BL(5)CBC45SL(1)CBC45SL(5)CBC55BL(1)CBC55BL(5)CBC55SL(1)CBC55SL(5)CBC65BL(1)CBC65BL(5)CBC65SL(1)CBC65SL(5)CCC45C(1)CCC45C(5)CCC45CS(1)CCC45CS(5)CCC45L(1)CCC45L(5)CCC55C(1)CCC55C(5)CCC55CS(1)CCC55CS(5)CCC55L(1)CCC55L(5)CCC65C(1)CCC65C(5)CCC65CS(1)CCC65CS(5)CCC65L(1)CCC65L(5)CIC45L(1)CIC45L(5)CIC55L(1)CIC55L(5)CIC65L(1)CIC65L(5)CRG45LCRG55LCRG65LCRHCRMDAN34DAN34DDAN38DAN38DDANSEDASKDASK-SDASKBDGAP06DGAP08DGAP10DGAP12DPS11DPS11EDPS15DPS15EDPU4011HEDPU4011HLDPU4011NEDPU4011NLDPU4015HEDPU4015HLDPU4015NEDPU4015NLDPU4511HEDPU4511HLDPU4511NEDPU4511NLDPU4515HEDPU4515HLDPU4515NEDPU4515NLDPU5511HEDPU5511HLDPU5511NEDPU5511NLDPU5515HEDPU5515HLDPU5515NEDPU5515NLDPU6511HEDPU6511HLDPU6511NEDPU6511NLDPU6515HEDPU6515HLDPU6515NEDPU6515NLDTF4011HEDTF4011HLDTF4011NEDTF4011NLDTF4015HEDTF4015HLDTF4015NEDTF4015NLDTF4511HEDTF4511HLDTF4511NEDTF4511NLDTF4515HEDTF4515HLDTF4515NEDTF4515NLDTF5511HEDTF5511HLDTF5511NEDTF5511NLDTF5515HEDTF5515HLDTF5515NEDTF5515NLDTF6511HEDTF6511HLDTF6511NEDTF6511NLDTF6515HEDTF6515HLDTF6515NEDTF6515NLDTS11DTS11EDTS15DTS15EFFA28HFFA28WFFD3606FFD3608FFD3610FFD3612FFD4006FFD4008FFD4010FFD4012FFD4506FFD4508FFD4510FFD4512FFL35FFL45
2004

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 Dentium USA as the applicant, including filings under its other names.

Decided510(k)DeviceDevice type
23 Feb 2022K213599SuperLineDZE Root-Form Endosseous Implant
4 Sep 2020K193341iCTmotor (WL-1)EBW Handpiece and Cord Foot Controller
23 Jan 2020K192436Healing Abutments and Cover ScrewsNHA Endosseous Dental Implant Abutment
4 Nov 2019K191634Scan Abutments and Comfort CapsNHA Endosseous Dental Implant Abutment
14 May 2018K172640Dentium Implantium & SuperLine ProstheticsNHA Endosseous Dental Implant Abutment
11 Jan 2018K171622Dentium Ti-BaseNHA Endosseous Dental Implant Abutment
7 Sep 2017K171126Implantium IIDZE Root-Form Endosseous Implant
17 Aug 2017K170384Dentium NR Line CAD/CAM AbutmentsNHA Endosseous Dental Implant Abutment
13 Jan 2017K160965SuperLineDZE Root-Form Endosseous Implant
16 Dec 2016K161713Dentium CAD/CAM AbutmentsNHA Endosseous Dental Implant Abutment
15 Sep 2016K160828Dentium Implantium & SuperLine ProstheticsNHA Endosseous Dental Implant Abutment
5 Aug 2016K160483Burn-out Cylinder and Angled Screw AbutmentsNHA Endosseous Dental Implant Abutment
20 Jul 2016K153268NR Line Implant SystemDZE Root-Form Endosseous Implant
12 Nov 2014K141457DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTSNHA Endosseous Dental Implant Abutment
26 Jan 2012K112045SIMPLELINE II ABUTMENT SYSTEMNHA Endosseous Dental Implant Abutment
13 Jan 2012K111162SLIM ONEBODY SYSTEMDZE Root-Form Endosseous Implant
22 Nov 2010K102308SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELSDZE Root-Form Endosseous Implant
20 Nov 2007K070228IMPLANTIUM PROSTHETICSNHA Endosseous Dental Implant Abutment
27 Jul 2006K052957IMPLANTIUM PROSTHETICSNHA Endosseous Dental Implant Abutment
16 Jun 2006K060501IMPLANTIUM IIDZE Root-Form Endosseous Implant
16 Jun 2006K060500SPEEDY ORTHODONTIC SCREWDZE Root-Form Endosseous Implant
21 Feb 2006K052823IMPLANTIUM ABUTMENTSNHA Endosseous Dental Implant Abutment
29 Jul 2004K041368DENTIUM CO., LTD. IMPLANTIUMDZE Root-Form Endosseous Implant

Some of these clearances are listed with FDA today by another company: Dentium Co.,Ltd(ICT branch) (1), SMD Dental Laboratory (1).

Registered establishments

EstablishmentLocationWhat it does
DENTIUM CO., LTD.FDA reg. 3004578807Suwon-si Gyeonggi, South KoreaManufacturer
Dentium USAFDA reg. 3005503242CYPRESS, CA, United StatesManufacturer

Other names on FDA records

Dentium Co., Ltd.

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9063757). 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.