Manufacturer registered with FDA
Sure Dent Corporation
SEONGNAM-SI, South Korea. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1586 registrations outside the US
- Establishments
- 1South Korea
Registered in 15 markets
Where regulators' registries name Sure Dent Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Sure Dent Corporation | 5 device types | — | Below |
| Canada | Health Canada | Registration holder | SURE DENT CORPORATION | 19 | 2011–2011 | Pure Global AI |
| Australia | TGA | Manufacturer | Sure Dent Corporation | 11 | 2006–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SURE DENT CORPORATION | 9 | 2005–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Sure Dent Corporation | 8 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SURE DENT CORPORATION | 6 | 2011–2023 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Sure Dent Corporation | 6 | 2023–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Sure Dent Corporation | 5 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Sure Dent Corporation | 5 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | SURE DENT CORPORATION | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SURE DENT CORPORATION | 4 | 2011–2022 | Pure Global AI |
| China | NMPA | Registration holder | 舒尔齿科有限公司Sure Dent Corporation舒尔齿科有限公司SURE DENT CORPORATION | 3 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Sure Dent Corporation | 3 | 2025–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Sure Dent Corporation | 2 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | Sure Dent Corporation, | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Sure Dent Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | Sure-PasteSure-Seal Root | 2024 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | RETRACTION CORDSure-CordSure-Cord Clean | 2009 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | GUTTA-PERCHA POINTS | 1998 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | ABSORBENT PAPER POINT | 1998 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Lister | Sure-Prep | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Sure Dent Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Vericom Co., Ltd. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Dec 2017 | K170950 | Well-Root ST | Vericom Co., Ltd. | KIF Root Canal Filling Resin |
| 21 Apr 2009 | K090992 | WELL-PASTE | Vericom Co., Ltd. | KIF Root Canal Filling Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SURE DENT CORPORATIONFDA reg. 9616142 | SEONGNAM-SI Gyeonggi, South Korea | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9034040). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.