Manufacturer registered with FDA
Dental Studio
Anyang-si, South Korea. Lists 21 dental device types with FDA across 1 registered establishment.
- Device types listed
- 21
- Brands and models
- 119
- 510(k) clearances
- 0as applicant
- Markets registered in
- 315 registrations outside the US
- Establishments
- 1South Korea
Registered in 3 markets
Where regulators' registries name Dental Studio as the manufacturer or the registration holder of a device.
RegisteredHome: South KoreaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dental Studio | 21 device types | — | Below |
| Taiwan | TFDA | Manufacturer | DENTAL STUDIO CO., LTD.DENTAL STUDIO · DENTAL STUDIO Co., Ltd. | 12 | 2015–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTAL STUDIO COMPANY | 3 | 2023–2023 | 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 Dental Studio currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | NSI Buddy | 2025 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mirror & Holder | 2017 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Easy Surgical 360 SuctionTITANIUM SUCTION SET A TYPETITANIUM SUCTION SET B TYPE | 2017 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | EASY IRRIGATION TUBE | 2019 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Langenbeck RetractorMidledorpt RetractorMinnesota Retractor | 2017 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Castroviejo calliperCrown gaugeImplant gauge | 2017 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Castroviejo scissorCrown & Gold scissorDean scissorGoldman-fox scissorIris scissorKelly scissorLagrange scissorLocklin scissorMicro Suture Scissors | 2017 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Implant Remover Screw [L]Implant Remover Screw [M]Implant Remover Screw [S] | 2022 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | RUBBER DAM FRAME | 2023 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | RUBBER DAM FORCEPSRUBBER DAM PUNCH | 2023 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Smart Flow Precision Syringe | 2025 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | APF2-ExplorerPROBE | 2017 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | AMALGAM BURNISHERSAMALGAM PLUGGERSCOMPOSIT INSTRUMENTSSTOPPING STOPPER | 2023 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | AMALGAM CARRIERS | 2023 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | CORD PACKERSROOT CANAL PLUGGERS | 2023 |
| Endodontic CuretteEKT · Class 1 | Dental hand instruments | Maker | Bone fileChiselEASY WINDOW SINUS CURETTEExcavatorGracey curetteSINUS CURETTESurgical curetteTitanium curettesWINDOW SINUS CURETTE (5SET) | 2017 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | MILLER 1XMILLER 21 | 2023 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Dual Edge ElevatorEasy LuxEasy PeriotomeEasy TwistHybrid ElevatorPeriosteal ElevatorPeriotomeRoot elevatorRoot Picker | 2017 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Sickle Scalers | 2017 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | MATRIX RETAINER | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ABUTMENT ALIGNMENT PIN KIT (AAP KIT)AERO DRILL KITAQUA SINUS LIFT KITBONE EXPANDER KITBONE EXPANDER KIT(A)BONE EXPANDER KIT(B)BONE PREP SURGICAL KITBone ScraperBONE TRIMMER KITBone well 50 moreDMZ KITEASY BONE SCRAPEREASY BONE SCRAPER(N)EASY CROWN INLAY & ONLAY REMOVER KITEASY EXTRACTION BASIC KITEasy Implant Guide KITEASY SCREW RETRIEVER KITEasy Tissue ScraperEZ Extraction PackageEZ EXTRACTION PACKAGE A TYPEEZ EXTRACTION PACKAGE B TYPEEZ EXTRACTION PACKAGE D TYPEHybrid Elevator SETIMPLANT & CROWN GUIDE KITIMPLANT & CROWN GUIDE KIT(S)IMPLANT & SCREW REMOVER KIT(S)IMPLANT REMOVER KITIMPLANT REMOVER KIT(S)INCISOR & SEPTUM TRIMMER KITMASTER KITMicro Bone ScraperNOVA Sinus KitONE SELF BONE COLLECTOR KIT_Type A(OSBC KIT)ONE SELF BONE COLLECTOR KIT_Type B(OSBC KIT)OSSEO-SCRAPEOSTEOTOME SETPIN GUIDE KITPRF BOXSCREW DRIVER HOLDER KITSIMPLE SCREW REMOVER KITSIMPLE SINUS CRESTAL REAMMER KITSIMPLE SINUS LATERAL REAMMER KITSINUS COMBINATION KIT (S)SINUS COMBINATION KIT(SINUS CRESTAL KIT & LATERAL KIT)SINUS CRESTAL APPROACH KITSINUS LATERAL APPROACH KITSIS Bone Expander KitSIS Fixture Guide KitSIS Fixture Remover KitSIS Screw Remover KitSOFT TISSUE TRIMMERSTARTer KITSURGERY BASIC INSTRUMENT KITSURGICAL PACKAGETISSUE PUNCH SETTITANIUM BRUSH KIT(A)TITANIUM BRUSH KIT(B)TREPHINE GUIDE KITTREPHINE SET (ELI KIT)TUNNELING TECHNIQUE BASIC KIT | 2017 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTAL STUDIOFDA reg. 3013547731 | Anyang-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054824). 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.