8plant Implant System
Hoowon Edi Co., Ltd. · Dental
Open FDA's page for this record- Third party flag
- N
- City
- Gimhae
- Advisory committee description
- Dental
- Address 1
- 20-13, Seogimhaesandan-Ro
- Statement or summary
- Summary
- Product code
- DZE
- Zip code
- 50967
- Applicant
- Hoowon Edi Co., Ltd.
- Decision date
- 2024-05-24
- Decision code
- SESE
- Country code
- KR
- Device name
- 8plant Implant System
- Advisory committee
- DE
- Contact
- Jihun Choi
- K number
- K231426
- Date received
- 2023-05-17
- Review advisory committee
- DE
- Postal code
- 50967
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Implant, Endosseous, Root-Form
- Medical specialty description
- Dental
- Regulation number
- 872.3640
- Device class
- 2
- Registration number
- 1226544, 3023265483, 9613866, 3007156625, 3011587630, 1038806, 1424785, 3012635238, 3001561923, 9613283, 3005031178, 3007283751, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 8031058, 3030690317, 3009756327, 3007597023, 1036836, 3008088588, 3006034256, 3007135442, 3009727738, 3018077122, 3005554774, 3017840051, 3003402534, 2133778, 2530808, 3005503242, 3011649314, 3010303805, 3009514134, 3003394627, 8044131, 3002807050, 3011461101 +288 more
- FEI number
- 3023265483, 3011587630, 1038806, 3006944200, 3012635238, 3001561923, 3005031178, 3002876349, 3007283751, 3002821504, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 3030690317, 3007597023, 1036836, 3008088588, 3006034256, 3007135442, 3009727738, 3018077122, 3005554774, 3017840051, 3003402534, 3005503242, 1000272060, 3011649314, 3010303805, 3009514134, 3003394627, 3003024548, 3002807050, 1000522098, 3011461101, 3016447764, 3010363503, 3014329459, 1000114355 +288 more