Data / Medical devices / South Korea / Sure Dent Corporation
Sure Dent Corporation: FDA-registered device maker in SEONGNAM-SI Gyeonggi, South Korea, 3 510(k) clearances
Sure Dent Corporation is registered with the FDA (registration 9616142) in SEONGNAM-SI Gyeonggi, South Korea. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 20, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9616142
- FEI number
- 3001421500
- Address
- #809, 52, Sagimakgol-Ro Jungwon-Gu, SEONGNAM-SI Gyeonggi, South Korea, 13210
- Owner or operator
- SURE DENT CORPORATION (9034040)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- June 3, 1998
- Registered through
- 2026
- Brand names listed
- ABSORBENT PAPER POINT, GUTTA-PERCHA POINTS, Knit-Pak+ Cord (Premier Dental Products Co.), RETRACTION CORD, Sure-Cord, Sure-Cord Clean, Sure-Cord Plus, Sure-Paste and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Manufacturer | accessdata.fda.gov |
| Cord, Retraction | MVL | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Manufacturer | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Manufacturer | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 20, 2017 | K170950 | Well-Root ST | KIF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| November 26, 2013 | K132526 | KNIT-PAK+ | MVL | Substantially Equivalent | Premier Dental Products Co. | accessdata.fda.gov |
| April 21, 2009 | K090992 | WELL-PASTE | KIF | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Preparer, Root Canal Endodontic
- All makers of Gutta-Percha
- All makers of Cord, Retraction
- All makers of Point, Paper, Endodontic
- All makers of Resin, Root Canal Filling
- All makers of Accessories, Retractor, Dental
Updated December 20, 2017. 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.