MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
Megagen Implant Co., Ltd. · Dental
Open FDA's page for this record- Third party flag
- N
- City
- Deagu
- Advisory committee description
- Dental
- Address 1
- 45, Secheon-Ro 7-Gil, Dasa-Eup, Dalseong-Gun
- Statement or summary
- Summary
- Product code
- NHA
- Zip code
- 42921
- Applicant
- Megagen Implant Co., Ltd.
- Decision date
- 2024-01-22
- Decision code
- SESE
- Country code
- KR
- Advisory committee
- DE
- Contact
- Seo MinGi
- K number
- K233450
- Date received
- 2023-10-20
- Review advisory committee
- DE
- Postal code
- 42921
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
- Harmonized identifiers (openFDA)
- Device name
- Abutment, Implant, Dental, Endosseous
- Medical specialty description
- Dental
- Regulation number
- 872.3630
- Device class
- 2
- Registration number
- 1226544, 3023265483, 9613866, 3006973441, 3007362683, 3005730680, 3011587630, 1038806, 1424785, 3012635238, 3010860907, 2244842, 9613283, 3005031178, 3007283751, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 3031162123, 8031058, 3030690317, 3009756327, 3007597023, 1036836, 3008088588, 3007135442, 3009727738, 3018077122, 3005554774, 3003402534, 3013465593, 2133778, 2530808, 3005503242, 3011649314, 3010303805, 3017450159, 3009514134 +342 more
- FEI number
- 3023265483, 3006973441, 3007362683, 3005730680, 3011587630, 1038806, 3012635238, 3010860907, 2244842, 3005031178, 3007283751, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 3031162123, 3030690317, 3007597023, 1036836, 3008088588, 3007135442, 3009727738, 3018077122, 3005554774, 3002768455, 3003402534, 3013465593, 3005503242, 1000272060, 3011649314, 3010303805, 3017450159, 3009514134, 3003394627, 3005597557, 3012205930, 3039641923, 3003024548, 3002807050 +342 more