FDA Device Establishments · JSON-LD · Markdown
FEI 3018097239 · Manufacture Medical Device · Status: Active
| FEI Number | 3018097239 |
|---|---|
| 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 |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DZA |
| Regulation § (21 CFR) | 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. Public-domain (CC0).