Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004578807

FEI Number

3004578807

Entity Name

DENTIUM CO., LTD.

City/State/Country

Suwon-si Gyeonggi, KR

Establishment Address

76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si Gyeonggi 16229, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dentium USA (Owner Number: 9063757)

Owner / Operator Contact Address

6731, Cypress, CA 90630, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191634

PMA Number

N/A

All Registered Proprietary Names

CDAB5520HL CDAB4515H CDAB5510N CDAB4505HL CDAB4515HL CDAB5510H CDAB4515N CDAB5520N CDAB5520H CDAB4505N CDAB5510HL CDAB4505H SBC55SL ASA45301018HT ASA55301518HT SBC45BL ASA55151518HT ASA55153018N ASA55151518NT ASA55301518NT ASA45301018NT ASA55303018HT ASA45302018HT ASA45151018NT SBC45SL ASA55303018N ASA45152018NT ASA55303018NT ASA45302018N SBC55BL ASA55153018NT ASA45152018HT ASA45302018NT ASA45152018N ASA55153018HT ASA45151018HT FXS7007C FXS4007BC FXS4507BC FXS4507C FXS6007C FXS5007C FXS3607BC FXS5007BC FX3814MLC FX4312MLC FX3812MLC FX4314MLC FX4308MLC FX3412MLC RAB45GNT FX4814MLC FX3810MLC FX3414MLC RAB45GN RAB45GH FX3410MLC FX4810MLC FX4808MLC FX4310MLC FX3408MLC FX3808MLC FX4812MLC GCMAB15ARS GCMAB15AR GCMAB15AS GCMAB20R GCMAB10ARS GCMAB10AS GCMAB30S GCMAB20S GCMAB10AR GCMAB10ASS GCMAB30R GCMAB15ASS SOFX483812R SOFX484310S SOFX483808S SOFX654808S SOFX483410R SOFX484310R SOFX483812S SOFX654310R SOFX654810S SOFX484312S SOFX654808R SOFX484308S SOFX654308S SOFX483408R SOFX483810R SOFX654312S SOFX483412R SOFX484308R SOFX483808R SOFX654812S SOFX654810R SOFX654308R SOFX483810S FXS6010C FXS4510C FXS7012C FX4010SWC FXS5010C FXS3610C FXS6008C FX3614SWC FX4510SWC FX4008SWC FX4014SWC FXS4008C FXS7008C FXS4508C FX4512SWC FXS3608C FX7010SWC FX3608SWC FXS4514C FX4012SWC FXS4014C FX5008SWC FXS3612C FX5010SWC FXS3614C FX4508SWC FX6010SWC FX5012SWC FX4514SWC FX3612SWC FXS5012C FXS5008C FXS5014C FX7012SWC FXS4012C FXS7010C FX6012SWC FX6008SWC FX7008SWC FX3610SWC FX5014SWC FXS6012C FXS4512C FXS4010C DAB55157NL CAB6535SL DAB4525NL CAB5515L AAB254535NL CAB6545L HAB654070L DAB6545NL SAB4510L CAB5545L AAB154540NL AAB155535HL CAB4525SL DAB5555NL SAB5535L DAB6555HL DAB4545HL BAB353018 SAB5515L DAB4515NL AAB154525NL HAB554070L BAB352018 CAB4515SL DAB65358HL DAB40105HL BAB351018 CAB6555L AAB254515NL CAB5545SL DAB55257NL DAB4535NL DAB5545NL BAB355018 DAB4555HL DAB6515NL AAB155540NL CAB4525L DAB6515HL BAB354018 AAB154525HL CAB5535SL AAB154535NL CAB6525SL HAB753050L AAB154515HL DAB45156HL HAB402020L DAB4525HL AAB254515HL DAB5515HL HAB454070L CAB4510L AAB155535NL AAB254525NL RAB45TNG HAB552035L DAB65258NL CAB4545SL HAB553050L DAB4510NL AAB155540HL DAB6535HL RAB45THG CAB6535L CAB5535L AAB255515NL SAB4535L DAB6535NL DAB40105NL DAB6545HL DAB45156NL AAB155520NL AAB255525HL SAB5545L HAB652035L CAB5515SL SAB4545L AAB255525NL AAB155515HL CAB6525L CAB4535SL HAB404070L DAB5545HL HAB453050L AAB155520HL HAB403050L CAB5525SL HAB402035L DAB4515HL HAB652020L CAB4535L DAB4555NL CAB6555SL HAB653050L DAB6525HL CAB5525L AAB154515NL HAB953050L AAB155525NL CAB5555SL CAB6545SL SAB5525L CAB6515SL HAB452035L HAB452020L CAB6515L SAB5555L DAB4510HL ASC2045 DAB4545NL CAB4515L CAB4555L BAB350018 AAB155525HL AAB154535HL AAB255535HL DAB6555NL DAB4535HL AAB255515HL SAB4515L DAB6525NL DAB5555HL DAB5535NL SAB4525L CAB5555L CAB4510SL AAB155515NL SAB4555L CAB4555SL AAB154540HL HAB552020L DAB65258HL HAB853050L CAB4545L DAB40105HT AAB155525NT DAB5515NT DAB5525NT DAB4510HT DAB4535HT DAB4535NT DAB65158HT AAB154515HT AAB254525NT DAB65158NT AAB154525NT DAB4545NT DAB75259HT DAB4545HT DAB6515NT DAB6515HT DAB5555HT DAB45156NT AAB254515HT AAB154515NT DAB45156HT AAB254515NT AAB155515NT DAB5545HT DAB5525HT DAB75359HT AAB155525HT DAB65358HT RAB45CHE AAB255535HT DAB6525HT AAB155535NT DAB4510NT DAB6535HT AAB254535NT RAB45GHT AAB255525NT DAB4515NT AAB155535HT DAB5545NT DAB6545NT AAB254525HT DAB4525HT DAB6555NT DAB65358NT DAB6535NT RAB45CHT DAB65258HT DAB4525NT DAB4555HT DAB5555NT AAB154535HT DAB55257HT RAB45GNE AAB255535NT AAB155515HT DAB4555NT RAB45CNE DAB65258NT DAB6555HT AAB254535HT DAB6525NT DAB40105NT DAB6545HT DAB5515HT DAB4515HT RAB45GHE DAB5535HT AAB154535NT AAB154525HT AAB255525HT DAB55157NT DAB5535NT DAB75359NT AAB255515HT DAB55257NT DAB75259NT RAB45THT TSTR-FS TSA2-FS CMAB14NA CMAB30N CMAB15HAL CMAB10HAL CMAB15NA CMAB14HAL CMAB10NA CMAB30LH SODAB4840O SORAB4852CO SOAAB6525O AAB154535HG SOSAB4870N RAB45CN SODAB6570O SORAB6568O SOCAB4818O DAB45156HG SODAB4870O AAB154525HG SOTAB6568TNG AAB254525HG AAB254535HG BIC3L AAB154515NG SOHAB4820 SOAAB6515O SOAAB4825O SOAAS2023 DAB55257HG SOSAB4855N DAB65158HG SOCAB4808O SORAB6568N SOTAB4852TOG SOHAB4840 SOMAB6530OG RAB45CH DAB65258HG SOHAB6520 SOSAB6555N ICA SODAB6540O AAB155525HG SOCS4835 SOTAB6568TOG SORAB4852O SOCS6543 SOMAB4830OG SOAAB4815O SODAB6555O SOTAB4852TNG DAB65358HG SORAB6568CO SOHAB6540 AAB155515HG SODAB4855O XBP6525H XBP5525H WFTP45 WFFD5012 WFFD3608 XLCS7029 WFTP35 WFFL35 WFFL45 WFFD4008 WFFD5008 WFFD3612 WFFD4010 WFFA28H WFFD3610 WFFD3606 DPU4015HE SFD3612 DTF6511HL XRFS2S SSE3L XHD17W XFD5831 DTF5511NL XLD2229 SODTF4852N ISGK GDPU3711S DTF6515HL SOXTD4333 RAB5520PHL CCC45CS(5) CCC65C(1) RAB6520PNL DPU4011NL SSP33H XPP203126 STA45S SODCC6570 DASK-S DTF5511HE XRSG8 GDRG55 XFD4335 XHD28 FFD3608 XFD5829SW STA45B XLDST02 XFD3831 XCD7031S GDANR36D XFA32W SOCAN4840P GDPU4313S XSIK XFHST04 FFD4510 SPU55BL GDPU5511S XSE3L CAN55LL SODPU6568O CBC65SL(5) CIC45L(5) CIC55L(1) DTF4015NL GBIC3L DAN38D XDE XPD2030 GXMFPA XFD2029 XRFRTO XTP5406 XPP162220T XDS GCAN43 SCJE4555 XLD2231 DPS11 SODBC65B XMF23W SLD0440 FGD2306 XSDAB55 XLD2233 FFD4506 DASKB GCC37(1) SMS30 STS09 SCC55L GDPU3713S DPU6511HL GDTF4311R XID27H SODIC48 UXIFB XID29W UXNF XLDST14 GXDGL XHDHT GDTF4315R SRT3035AS XHD26T CBC55SL(5) CIC65L(5) GDPU3713R XFD4835 XMF18W GXNP XRCA1 RAB4520PHL XSDAB65S XFD3833 SSE1L XDS8025 GDTF3713S CRG65L SAN45D XHD25W XLD2635 SCC45L(1) XFDST14L SODCC4840 SGD2310 SSE4L SODBC65S XTP3404 GSPU50 GSTF50 XGD1520 XSE2L XGSFK XSDAB45S CCC45CS(1) CBC55SL(1) CCC65CS(1) SCC55L(1) DTF4015HE SODCC6555 XLD2607 SODBC48B GXSD21W GCC43(1) SDA17R SPU45BL SODCC4870 DAN38 GCC55(1) GDPU4313R SPS09 DTF4011NE XPP162212 DGAP10 XTS40 DPU4011HE SOCAN6540P FFD3612 GDTF4311S XFDST08L XRHR25 XITB XRFS2 DAN34D XID32W DTF4515HL FTP35 GXPP162243 XFC3607 GXID30H XFD3035A SOS30 DPU4511HE DTF4515NL SDK CCC65L(1) XFH4835 DPS11E XFD3835 XHD13 DPU4511NE GDPU5513R FFD4008 GXID27H XSDAB45 DPU5511NE XTP2403 GDTF3711R DPU5515NL GDTF3711S XBC305013 GDPU5511R DPU4515NL DTF5515NE XCS6029SW XCS5032SW GCAN55 XIT DTF5511HL GBIC2L XFD2033 DPU6515HL XFH3435 DTF5515HE SAN55D GDTF5513R GDTF5513S DTF5511NE XSKB GDTF3715S CCC65L(5) DTF4011HE GLD3009 FGD2310 XMF28H SLD0428 FFD4006 SOCAN4870P CAN65LL FFD4512 XRFRT SGD2308 CAN55SL GXSD25H XRT084025 CCC65CS(5) CCC55L(5) DGAP06 XTP4405 DTF4511HL XFD4331 FGD2308 XSE3 XSE1 FFA28H DTF6515HE XPK XFC4507 XFD3829 XAD21W DTS15 DPU5511HE XSE4L FFL45 XFC4007 XFA24W STF45BL XID32H SCC45T SPU45SL GDTS11 XFD4829 GDPU4311S GDANR30 GADH55 SODTF4852O GLD3011 SRGSL GSPP50 DPU5511HL FFD4010 CCC55C(1) XFH4335 XRFS STF55SL DTF6511NE SOXHD27W FFD3610 XCD6031S DPU4011NE DPU4515HL XRSTR DPU6515HE SODTF6568O RAB4520PNL DTF6515NL XED331035D GDTF4315S STP25 DPU6511NE XLDST10 GADH37 XFDST06 XMF23H XFDST12 GADH43 XFDST04L DPU4515NE SGD2312 FTP45 STA55S GDTF5515R CCC45C(5) CCC45L(5) CCC45C(1) CBC55BL(1) CCC55C(5) GXRCA SFD3608 GXNTW XHD21 GDPU5515R DPS15 BANL XGSSK XCS7030SW SCC45L DPU4015HL GXSD28W GXID29W XAD25H XID26W XSE4A XFD5035A STF45SL DTF4015HL GFD3011 XID30H XFD3431 DPU6511NL XFD3433 SCJI4565S DTF4015NE XCS5529SW GXSA21W DPU6515NE SPU55SL CIC55L(5) CCC55CS(5) XHD17H XFD4035A XFH3835 GXID24W GDTF5511R XHD21W SFL25 CCC55L(1) XFA30H CBC65BL(1) SRT3535AS XFD3841 GDPU3711R XFD3435 XFD3429 XHD30T CBC65SL(1) FGD2312 GSPS09 XAD26T CRG45L XCS4032SW CAN45SL XRB3033 DTS11 XTP7408 SOXTD3433 XFDST04 XCS3629SW SOCAN6570P GXIFU CBC45BL(5) CBC45SL(5) GDPU4311R FFA28W XCD5033S STF55BL STA55B XRFRTF GDRG37 RAB6520PHL XLD2629 DTF4515HE XRT332035 SSE2L SDA25R GXSD15W XIFB XHD30H GXSDD30H SAN55L XFDST02L XRFRW FFD3606 XFDST12L ASAH XCS3632SW XFA27H XFC5007 XFDST06L SCJI4565 GXSD25W XCD3633S DPU5515HL XFC6007 XRB2033 FFL35 XSE2A SAN45L FFD4012 GDTF5511S DPU5515HE GXID26W SRGBL XFA29W SODCC6540 GDANR36 XLD2207 IPST21W XIH GDTF3715R CCC65C(5) CBC45SL(1) XTP9410 GXID32H SRM XCS4529SW XSE3A GSRM XSDAB65 DAN34 DPU4511NL SCC55T XRSG11 SPP55L XCS4029SW XFDST02 DTF6511HE SODAN65 CCC55CS(1) XFD4833 GDPU5515S DTF4515NE DPU5515NE SODIC65 XFD4341 XFD4333 SCC55L(5) GDPU4315R XFDST10L RAB5520PNL GSRG SOCAN6555P DPU4011HL DPU4511HL GDPS11 XRT064025 UXIKTB DTF4011HL XST083025 GDANR30D XHD25H DPU6515NL DASK FFD4508 GDTF3713R XFA26W XFD4831 DGAP12 XLCS4029 CIC65L(1) XIPB DPS15E GDTF4313R XMA21W XCS5029SW XAD30T XPP162226T SOXTD4833 DTF6511NL CRH XHD21T XSDAB55S XFDST14 XCS4532SW XLD2641 XHW XFDST08 GDPS13 DTF5515HL CAN65SL GDTS13 SOXIK DTF5515NL SODCC4855 SCJE4555N XLDST06 XLD2631 DTF4511HE CIC45L(1) XLCS5029 XHDD30H SODPU4852N XFD4841 XRB4035 SFD3606 XHD15 XID24W XAD25W SOCAN4855P GSCC50 DTF6515NE XGD1528 DTF4511NL SGD2306 XMAA1 CRM XSKL GDTF4313S DTS11E DTF4011NL GDPU3715S XCD4533S XCS7029SW GFD3009 XSE2 XFA21W SODBC48S XLDST12 DPU4515HE XCS6030SW GDPU5513S XGSFKW CCC45L(1) DGAP08 XLCS4529 GLD3013 GDTS15 GSCJI45 XSK XIP GSAN50 XCD4033S GSTS09 XRRHD DPU5511NL DTS15E GCAN37 XRT372035 GMNT WFFD5010 CBC65BL(5) DPU4015NL XPP203120 XTP6407 XSE1L FMS49 XFA32H DTF4511NE CAN45LL XLDST04 XFD3441 XHD28T XFDST10 GDPS15 BOS GICA FOS49 XRHR20 GDPU3715R DPU4015NE XFC7007 DANSE XFD4329 DPU6511HE SCC45L(5) XLD2241 SOXTD3833 GXBA21W SDKB XNTW XLD2633 WFFA30W XLCS3629 XAD27W CRG55L SFD3610 XMFPA2 UXIKT XTP8409 GDRG43 GDPU4315S XLD2235 SPP45L XLDST08 XHD27W SODAN48 GDTF5515S CBC55BL(5) CBC45BL(1) WFFD4508 XLCS6029 XBP4525H WFFD4012 WFFD4510 WFGD2304 WFFD4512 WFFD4506 WFFD4006 WFFD5006 ISC55BT ISC45ST IHAB5010TH IHAB6006TN IHAB5008TN IHAB4008TH ISC55SP IHAB5008TH IHAB4006TN ISC45BP IHAB4010TN IHAB6008TN IHAB5006TN IHAB5006TH IHAB6006TH IHAB5010TN IHAB4010TH IHAB6010TN ISC55BP IHAB4006TH IHAB4008TN IHAB6008TH IHAB6010TH ISC45SP ISC55ST ISC45BT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-01-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-08-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-05-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2007-12-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-08-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-07-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-11-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-08-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-09-26
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2015-07-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-01-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-02-09
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2004-11-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-11-04

Official Correspondent

No official correspondent registered.

US Agent Details

EUNKYUNG SON Email: json@dentiumusa.com Phone: (714) 2260229

Related Public Records

Same Entity

Dentium USA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005503242	Dentium USA	CYPRESS, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

Similar Registrations

Registration Number	Establishment Name	Location
3013578168	DDS CARIBBEAN CORP	Guaynabo, PR, US
3030690317	TRATE LLC	Tamarac, FL, US
3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004578807. Last updated year: 2026. Please use registration number 3004578807 when referencing this establishment in official correspondence.