FDA Registration Active 🇰🇷 South Korea

MAB65258NE

Reg #: 3004578807 · FEI: 3004578807 · Expires 2025
Products
1
Proprietary Names
328
Establishment Types
1
Classifications
1

Registration Details

Registration Name
DENTIUM CO., LTD.
Registration Number
3004578807
FEI Number
3004578807
Status
Active
Expiry Year
2025
Initial Importer
No
Address
76, Changnyong-daero 256beon-gil, Yeongtong-gu
City
Suwon-si Gyeonggi
Country
KR

Regulatory Submissions

510(k) Number
K172640

Owner / Operator

Firm Name
Dentium USA
Operator Number
9063757
Address
6731
City
Cypress
State
CA
Postal Code
90630
Country
US

Products

Device Name Product Code
Abutment, Implant, Dental, Endosseous NHA

Proprietary Names

MAB65258NE ASA551510RH MAB55157HE CAB5545 MAB75359H AAB154515H DAB4525N ASA553010RH CAB5515 CAB5555 CAB6555S MAB75259N AAB254515NE DAB5515NE DAB4555H SAB5545 AAB154515N CAB4535SE ASA4530H CAB4515SE DAB4510NE ASA551520RN CAB5555E DAB6545N DAB6545HE DAB5545HE DAB5555NE HAB552020E MAB45156N HAB552035E DAB5525H HAB452035E ASA552030RH CAB6535S MAB65358NE MAB75359HE ASA551520RH MAB55257H SAB5515E AAB255515NE DAB5555HE SAB4545E AAB255535N ASA5520N TAB4530HG DAB4515HE MAB65358N DAB5545NE CAB5535E AAB255515N DAB4545HE AAB155535H CAB5525 DAB4525HE MAB75259H AAB255525N DAB4525H ASA553030RN CDAB5520NE ASA451530RN CAB4535 AAB255535HE DAB4535H SAB5555E DAB5535H CDAB5510HES ASA451510RN AAB255535NE DAB5515N DAB5545H CAB5535S AAB255525H ASA452020RH CAB4535E DAB6515H AAB254525N ASA5510H AAB155535NE DAB4555N ASA553020RH SAB4535 CAB6535 AAB155525HE ASA552020RN MAB55257NE RAB45CLH CDAB4515HE AAB155525H CAB6555SE CAB4525 ASA4520H DAB6555HE CAB4555 AAB255535H CAB4515S CAB4545 MAB55157N ASA453020RN CAB5555SE DAB4515H MAB45156H DAB5525N DAB4555NE ASA551530RN DAB5515HE ASA551510RN AAB154535NE HAB654070E CAB6515S HAB652035E CAB4545SE DAB4510H ASA451530RH CAB5545E SAB4555E DAB6535N ASA453010RN ASA552010RN CAB5525S HAB452020E AAB254535HE CAB6545E MAB75359N CDAB4505NE TAB4520HG CDAB4515NES AAB255515H RAB45CLN MAB75359NE CAB4545E ASA551530RH SAB5525E MAB65358H ASA4510N SAB5515 CAB4515E DAB6525HE AAB154515NE DAB6545NE AAB154525HE HAB402035E HAB454070E ASA552010RH MAB65158HE ASA453030RH SAB4535E HAB403050E AAB155515N MAB40105NE CAB6545 HAB953050E CDAB5520HE AAB154515HE DAB4510HE HAB402020E CAB6535SE ASA453030RN CAB4545S SAB5545E AAB155525N DAB4515N AAB254515N ASA451510RH DAB4525NE ASA5520H DAB5535HE CAB4555E SAB4515 CAB4510 DAB6555NE AAB154525N ASA4530N DAB5515H CDAB4515NE CAB6525 DAB6515HE CDAB5510HE MAB40105N MAB65158N ASA452010RH AAB154535HE CAB4510S CAB4510SE CAB5535SE ASA552030RN AAB254525H MAB55257HE AAB154535H MAB45156HE AAB155535HE CAB4535S AAB254535H CAB6525E DAB6555N SAB5525 CAB6515SE MAB65258HE ASA453010RH HAB453050E SAB4545 AAB154525NE ASA4520N DAB4535N AAB155525NE SAB4525 CAB6545SE CAB5535 SAB4525E CAB5515S CAB4555S CDAB4505HES MAB55157H ASA553020RN CAB6525S AAB254525NE DAB4545H DAB4535NE AAB155515HE DAB6525NE DAB6535H AAB255515HE DAB5555H HAB853050E ASA4510H ASA452020RN ASA5510N CAB5555S SAB5555 ASA452030RH AAB154525H AAB254535NE CAB6555E DAB6545H HAB404070E SAB5535 ASA451520RH MAB55157NE AAB155515H CDAB5520NES AAB254515HE CAB6545S CAB4525S MAB40105HE ASA5530N MAB40105H ASA553030RH CDAB5520HES AAB155515NE MAB45156NE TAB4530NG MAB65358HE CAB6515E CAB4515 CAB5525SE CAB4525SE DAB5535NE DAB6515N MAB75259HE DAB6515NE HAB553050E SAB4510 HAB554070E HAB952035E CAB6555 MAB65158H AAB155535N SAB4555 ASA452010RN DAB4545NE ASA552020RH CDAB5510NE CDAB4505HE ASA553010RN HAB852035E DAB6525N DAB5545N CAB6535E ASA453020RH SAB5535E CAB6525SE SAB4510E HAB653050E DAB6535NE CAB5525E CAB6515 SAB4515E AAB255525HE CAB4555SE HAB753050E HAB652020E DAB5555N DAB4555HE MAB65258N CAB5515E DAB6535HE HAB752035E DAB4535HE SAB5510 CDAB5510NES MAB75259NE CAB5545S MAB65158NE MAB65258H AAB255525NE AAB154535N ASA452030RN TAB4510NG DAB4515NE DAB6555H AAB254515H TAB4520NG CDAB4515HES CDAB4505NES DAB5525HE ASA451520RN DAB4510N DAB6525H DAB5535N AAB254535N AAB254525HE ASA5530H CAB4525E MAB55257N CAB5515SE TAB4510HG DAB5525NE CAB5545SE DAB4545N

Establishment Types

Manufacture Medical Device