Manufacturer registered with FDA
Spident Co., Ltd.
INCHEON, South Korea. Lists 17 dental device types with FDA across 1 registered establishment, and holds 22 510(k) clearances as applicant.
- Device types listed
- 17
- Brands and models
- 39
- 510(k) clearances
- 222009–2026
- Markets registered in
- 13375 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 13 markets
Where regulators' registries name Spident Co., Ltd. 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 | Spident Co., Ltd. | 22 clearances | 2009–2026 | Below |
| European Union | EUDAMED | Manufacturer | Spident | 166 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Spident Co., Ltd.SPIDENT CO.,LTD. | 40 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Spident Co Ltd | 25 | 2004–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SPIDENT CO., LTD. | 23 | 2016–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SPIDENT CO., Ltd.SPIDENT CO. LTD. · SPIDENT CO., LTD. | 22 | 2009–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SPIDENT CO., LTD. | 21 | 2022–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | SPIDENT Co., Ltd. | 20 | 2022–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SPIDENT CO LTD.SPIDENT CO., LTD · SPIDENT CO., LTD. · +1 | 18 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Spident Co. Ltd | 14 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SPIDENT CO., LTD. | 13 | — | Pure Global AI |
| China | NMPA | Registration holder | 斯派丹公司SPIDENT CO., LTD斯派丹公司SPIDENT Co., Ltd. · 韩国斯派丹有限公司SPIDENT CO., LTD · +1 | 9 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | SPIDENT CO., LTDSPIDENT CO.,LTD · Spident Co. Ltd. · +1 | 4 | — | 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 Spident Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Core It DualEsCom 100EsCom250EsFlowEsFlow PLUSMagnificent Flowable CompositeSeal itTemp.ro, Temp.ro Flow | 2011 |
| Dental CementEMA · Class 2 | Dental cements | Maker | EsCemEsCem RMGIEsTemp ImplantEsTemp NEResin CementResin-Modified Glass Ionomer Cement | 2011 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Bonding AgentEsBondFineEtchK-Bond Universal | 2012 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | OrthoFitOrthoFit Aligner | 2026 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | VioSealVioseal X | 2024 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | NOP Dental Needles | 2012 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | EsTemp C&BTemporary Crown & Bridge Material | 2022 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Block-Out Resin | 2020 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | FOCUS | 2012 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Spident Bite Tray | 2012 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | FineDam | 2012 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | Retraction Cord | 2016 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | Base It | 2016 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta PerchaGUTTA PERCHA POINTS | 2006 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Accessory PointsPAPAER POINTSPaper Point | 2006 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | SoftPrep | 2012 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | I-SilVinyl Poly Siloxane | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Spident Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Oct 2026 | K262433 | OrthoFit Aligner (OrthoFit Aligner A2) | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Sep 2026 | K262983 | EsTemp Implant | EMA Dental Cement |
| 21 Sep 2026 | K262982 | Core·it Dual | EBF Resin Tooth Shade Material |
| 11 Sep 2026 | K262050 | Vioseal X | KIF Root Canal Filling Resin |
| 2 Jul 2026 | K261129 | OrthoFit | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 20 Jun 2025 | K250566 | EsCem RMGI | EMA Dental Cement |
| 30 May 2025 | K250317 | EsFlow PLUS | EBF Resin Tooth Shade Material |
| 7 Nov 2024 | K242702 | VioSeal | KIF Root Canal Filling Resin |
| 1 Nov 2024 | K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | KLE Resin Tooth Bonding Agent |
| 22 Jul 2024 | K241445 | K-Bond Universal | KLE Resin Tooth Bonding Agent |
| 24 Jul 2023 | K231523 | EsCom250 | EBF Resin Tooth Shade Material |
| 19 Dec 2022 | K214076 | EsCem | EMA Dental Cement |
| 10 Mar 2022 | K214071 | Hexa-Temp | EBG Resin Temporary Crown and Bridge |
| 30 Sep 2016 | K161774 | i-Sil | ELW Impression Material |
| 11 Jun 2014 | K134022 | BASE IT | EJK Calcium Hydroxide Cavity Liner |
| 10 Jun 2014 | K134021 | ESTEMP IMPLANT, ESTEMP CLEAR | EMA Dental Cement |
| 24 May 2012 | K120767 | ES BOND | KLE Resin Tooth Bonding Agent |
| 3 May 2012 | K120768 | ES FLOW | EBF Resin Tooth Shade Material |
| 25 Feb 2011 | K110428 | ESCOM 100 | EBF Resin Tooth Shade Material |
| 3 Mar 2010 | K100413 | TEMP IT | EBF Resin Tooth Shade Material |
| 17 Feb 2010 | K100290 | ESTEMP NE | EMA Dental Cement |
| 26 Aug 2009 | K092572 | CORE*IT DUAL | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Essential Dental Systems, Inc. (3), NuSmile, Ltd. (1), HEXA Dental (1).
Also lists devices cleared under other names
Spident Co., Ltd. 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: Good Doctors Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Feb 2010 | K093751 | CL-DC20, CL-DC21 | Good Doctors Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SPIDENT CO., LTD.FDA reg. 3006113314 | INCHEON Gyeonggi, South Korea | Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9089446). 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.