# IZENIMPLANT CO., LTD.

FEI: 3018097239
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: Izenimplant Co., Ltd. (#10080021)

Address: 1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si Gyeonggi, 17703, KR

Mandatory US Agent: Withus Group Inc

## Products

Total registered: 1
Top product codes: DZA
Regulation §: 872.4130

Proprietary names: Guide Drill (Non-stopper) (Model: GDN3F20S, GDN3F20L), Step Drill (Model: TD2F2206, TD2F2207, TD2F2208, TD2F2210, TD2F2211, TD2F2213, TD2F2215, TD2F2506, TD2F2507, TD2F2508), Lindemann Drill (Model: LD4F25L, LD4F20S, LD4F20L, LD4F25S, LD4F35M), ZENEX Guide Twist Drill (Model: ZGTD5507W, ZGTD5508W, ZGTD5510W, ZGTD5511W, ZGTD6505W, ZGTD6506W, ZGTD6507W, ZGTD6508W), ZENEX Guide Twist Drill (Model: ZGTD3015R, ZGTD3605R, ZGTD3607R, ZGTD3608R, ZGTD3610R, ZGTD3611R, ZGTD3613R, ZGTD3615R), ZENEX Guide Twist Drill (Model: ZGTD4607W, ZGTD4608W, ZGTD4610W, ZGTD4611W), ZENEX Guide Initial Drill (Model: ZGID2204R, ZGID2207R, ZGID2208R, ZGID2210R, ZGID2211R, ZGID2213R, ZGID2205M), Twist Drill (Non-stopper) (Model: TDN3F46S, TDN3F46L, TDN3F41S, TDN3F41L, TDN3F36S, TDN3F36L, TDN3F30S, TDN3F30L), Taper Drill (Model: TAD3F3506, TAD3F3507, TAD3F3508, TAD3F3510, TAD3F3511, TAD3F3513, TAD3F3515, TAD3F4006, TAD3F4007), BT Profiler for Healing Abutment (Model: BTP50M, BTP50R)

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223018097239%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3018097239