Data / Medical devices / South Korea / CSM Implant
CSM Implant: FDA-registered device maker in Daegu, South Korea, 4 510(k) clearances
CSM Implant is registered with the FDA (registration 3005998060) in Daegu, South Korea. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 19, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005998060
- Address
- B205, Techno B/D, Kyungpook University 47, Gyeongdae-ro17-gil, Buk-gu, Daegu, South Korea, 702-832
- Owner or operator
- CSM Implant (9090832)
- Roles
- Manufacturer
- First device listed
- August 8, 2006
- Registered through
- 2027
- Brand names listed
- Bone Carrier, Bone Condenser, CSM Submerged3-L Implant System, Countersink, Depth Gauge, Drill Extension, Dummy, Fixture Analogue and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 19, 2018 | K173141 | CSM Submerged3-L Implant System | DZE | Substantially Equivalent | Csm Implant | accessdata.fda.gov |
| April 27, 2012 | K120043 | CSM INTERNAL-R IMPLANT SYSTEM | DZE | Substantially Equivalent | Csm Implant | accessdata.fda.gov |
| October 14, 2011 | K111120 | CSM SUBMERGED-R IMPLANT SYSTEM | DZE | Substantially Equivalent | Csm Implant | accessdata.fda.gov |
| March 22, 2011 | K102635 | APOLONIA LASER IMPLANT SYSTEM | DZE | Substantially Equivalent | Csm Implant Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
Updated September 19, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.