Manufacturer registered with FDA

Shenzhen Risun Technology Co., Ltd.

Shenzhen, China. Lists 3 dental device types with FDA across 1 registered establishment.

FDA owner/operator10029850Contract manufacturerForeign exporterManufacturer

Device types listed: 3
Brands and models: 268
510(k) clearances: 0as applicant
Markets registered in: 21 registrations outside the US
Establishments: 1China

Registered in 2 markets

Where regulators' registries name Shenzhen Risun Technology Co., Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: ChinaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Shenzhen Risun Technology Co., Ltd.	3 device types	—	Below
Israel	AMAR	Manufacturer	Shenzhen Risun Technology Co Ltd	1	—	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 Shenzhen Risun Technology 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
Oral Irrigation UnitEFS · Class 1	Oral irrigators	Maker	A5923; A5925; S620; S620 DELUXE OI100R OI-100R PLUS OI-200; S625-Deluxe PlusA5925A5930A5999Aquapik 100; BC-2005; BX-F1; BX-F2; C1657789; D50Aquasonic F5335AS-FLOS F5020AS-FLOS-PRO-BK,AS-FLOS-PRO-WHAS-FLOS-PRO3 F5335AS-FUSN T2045 88 more AS-HDCS-PROAS-ICON-FLOSAS-KIDS-FLOSAS-PREC-FLOSCOSLUS C20, COSLUS W40COSLUS C31, COSLUS E40, COSLUS E1COSLUS C51/CX51 F5333, COSLUS CX50D50BS; D50WS; D51; D52; D92; D9201; D9202; D9203; D9204; D9205; D9206; D9207; D9208D52-BE1; D52-BK1; F18-WE2; F18-PK1; F09-WE2; F09-BK1; F18; F18-BK3; F18-WE10D52-WE3, D52-BK1, D52-WE4, D52-BK2D9209; D9210; D9211; D951; D952; D953; D954; D955; D956; D957; D958; D959; D960; D961; D962; D963; D964; D965;DC-03154; DS-600; EKA001; EKA005; EL-V8; ES1014336; EUAIW5002; F05; F5015A; F5015BDL-5003F21F22-BE2F22-WE2F23-DG1F23-OE2F29-WE2; F29-GN2F29-WE3, F29-BK1, A5962, F26, F29; F29-WE4; F29-BK2F30-BK1; F30-GY1F32-WE1; F32-BK1; F32-BE1; F32; F32-WE2; F32-BK2F5F5004; F5003; F5007; F5008; F5010F500801F5012; F5013; F5015; F5015A; F5015B; F5020; F5021; F5022; F5101; F5102F5012D0-EUR-WE90F5013F5020F5020A; F5020B; F5020C; F5020D; F5020E; F5020E; F5020E; F5022; F5023; F5025; F5501A; GOI3110WF5021AF5021BF5025AF5026; F5027; F5028F5029F5029AF5030; F5030AF5031, F5032, F5035, F5037, F5108F5038; F5039; F5040; F5041; F5043F5039-W, F5039-B, F5052-W, F5052-BF5043A, F5055, F5055AF5047, C50F5048, F5049, F5052F5056, CX20, EX40F5102A; F5102A; F5105; F5501; A5901; F5105; F5106F5105AF5106A; F5026A; F5026B; F5530CF5107F5330F5341F5530GS28149-0100 DP28149-0100 GS28150-0100 DP28150-0100; HC-T5100; HC-T5300; HOC430; HOC460; HT-1-3GSX-1HOC600HOC700HT-3; IP-1502; IP-1503; JUMOIF01; Kealive; M3; M5102; M5102; MT420; MRPC; OI-100R; OI-100R PLUS; OI-200; OI-320IT-5106L-HAO01; BL-HMIRG-550; SI-HMIR-700Mornwell D52Mornwell F29,Mornwell F29-BK1,Mornwell F29-WE2,Mornwell F29-WE3Mornwell F38Mornwell F42OC-001OC-002OC-003OC-010OC-100OC-200OC-300OI-535; OJ-1200B; OJ-750B; OR-888; OR-F50; P-27; PHWF35WT; R08-0016; RO-110; RO-110-TIPOI27ROMIO-100Oral Irrigation: CX50, W2OTS101, OTS102SP-04505STO-PO2016; STO-PO2016O; STO-PO2016U; STO-RN2SO; STO-RN2SU; TTP-CTI-1; TTP-OI-2; TTP-OI-3TB-2223WTriple Bristle DC-14TTP-PCOMBO-W; TTP-PRO1000; TTP-Pro2000b; TTP-Pro2000w; TTP-WFJR-Green ; TTP-WFJR-PinkTTP-PWF-1TTP-WFJR-Blue; USAAIW5002; VA-EB006; VIP-006; VL-1502; WF150W; WF180W; WFR-100; WI-911; WY-5088UNIT, ORAL IRRIGATIONWIDS4DWTRSTX386W1, HX386M1, HX386B1, HX381W1, HX381M1 HX3826/21, HX3826/23, HX3826/24, HX3824/21, HX3827/21, HX3822/14, HX3822/11ZTH-F5029 NEW, ZTH-F5029 PRO10512147-10209-007015013B-WE2; 5013B-WE3; 5013B-BK2; F27-BE2; F27-WE2; F27-BK1	2009
Powered ToothbrushJEQ · Class 1	Toothbrushes	Maker	A2097, A2961A2767 AS-HEAD-PLQ/AS-HEAD-VAR, A2768 AS-HEAD-EXW, A2769 AS-HEAD-SEN, A2776 AS-HEAD-FUSN, A5901 AS-TIP-S5A2767, A2768, A2769A2913; A2915; A2916; A2922; A2928; A2929; A2933; A2936; F5010A2935A2947, AS-KIDS-HEAD-2PKA2961A2999A5930 AS-TIP-I5, T2421T2 AQP2, T2421T3 DP2, T2272 AQK2AQ1 149 more AQ2PAQLCDAQPS, T901AS-CLNC-BK, T2037, T2407, T2404AS-HEAD-VDUOAS-SLIM-BK T2130AS-SLIM-RG T2130AS-SLIM-WH T2130AS-TBSH-BSAS-TBSH-CHAS-TBSH-DUOPAS-TBSH-RGAS-TBSH-WHAS-VDUO-LBLP; VN-ET12-BK; T2051; T2051T1; T2051A1; T2271; T2820Aura Clean SystemBA-0103-BLK; BA-0103-WHT; BA-0201; AQ1;T2082C; BH2OSUV001; BX-150; BX-250; BX-350BA-0106BA-0130BA-0131BA-0132BA-0133BA-0134BA-0135BA-0139, BA-0140BA-0150BA-0151BA-0152BA-0155-WHTBX-450; D01; D01B; D02; D02B; D02BS; D03; D90; D901; D902; D903; D904; AQ2COSLUS C50,T2273DAZ-7024; DAZ-7025; DAZ-7026; DAZ-7042; DAZ-7044; DAZ-7045; DAZ-7047; DAZ-7051; DAZ-7053; DAZ-7055DAZ-7063; DAZ-7065; DAZ-7070-S; DAZ-7070-T; DAZ-7071; DAZ-7072; DAZ-7080-P; DAZ-7081DAZ-7142; DAZ-7144; DAZ-7145; DAZ-7147; DAZ-7180; DC-03175; DM25098-0103; DP23095-1100; DP23095-1200DP23096-1000; DP23264-0500; DP2; DP23264-4500; DP23264-4600; DP25098-0103DP25104-0102; DP25105-0102; DP25288-0103; DP25289-0103; DP27146-1100; DP27146-1200DRX-10000CDDRX-6000; DRX-6000 BH2DRX-7000DRX10000 Intelisonic; DRX11000; DRX11000 BH2; DRX9000 Revolation; DT-001; EKA002EKA003; Electronic Toothbrush; ES1012785; ES1014746; ES1014877; ES1014964ER109001EUAIB2030; EUAIW2030; EUAIW2081; FG6062; GO-9301; GO-9450; GO9301F5501; A2946; S400; S400 DELUXE; S420-BE DELUXE PLUS; S420-BK DELUXE PLUSGEHP191AP-PTGO9450; GO9501; GS23096-1000; Healthy Clean Sonic 6000; HP-STX; HSD-008; HSD-010; HT-1; HT1000Health Tec.940-10005; Health Tec. 940-10001HP141AHP142AIDDYS-1805-W1, IDDYS-1805-W1; KATBRSHUVSA; HP107A; Atmoko; EllesyeIRM-1; T2026; BA-0150IT989LHH-ETB_IB2M2911; M2916; MT110C; M2032B; P11; P11plus; Plomo; MT110; Max Clean Sonic 5000Mornwell A2729Mornwell T25Mornwell T37,Mornwell T37-BK1,Mornwell T37-WE1,Mornwell T38,Mornwell T38-BK1,Mornwell T38-WE1Mornwell T39N-02, N-01, N-15, Slim, C30, CX30N-16NV-08093OFI-200OR-T50; OR-T80; OSUV001; OTR-100; PRO-40; PSP0814; R08-0018; RBH-01; RBH-8; RBH8-BEOR3800P9T2023RBH-7 / RST2921 /RBH-8 /RST2090RBH8-BK; RBH8-RD; RET200; RH-250; RH-350; RS2033D; RS2082B; RS2082B Vibrite WaveRST2710S2,D2,K7S,E11,P11,P9,P10,E10,T9,P80,P80SS420-RD DELUXE PLUS; S430; S450 DELUXE; S450-BE DELUXE PLUS; S450-BK DELUXE PLUSS450-RD DELUXE PLUS; S450-SR DELUXE PLUS; S50; S620; S750SA008; SB23096-0500; SB23096-1000; SB23096-4500; SB23096-4600; SB27146-4500SB27146-4600; SBS-7180; SFR201; SFR401; SFT050; SFT100; SFT150; SFT200; SHE037; Sonic Clean PRO 800Shinbicare S600T2028T2031S; T2032; T2032A; T2032B; T2032S; T2056; T2056ST2041,S1, S 1T2042; T2203A1; T25; TBS28W; TBS31W; TBS40WT2045T2048T205101; T2412; T2412A1; T2213; T2232; T2233T205606; ESHP107ABUS; T205605;AMHP107AB; LA-327; M2032A,Plomo; M2206,Azul; M2206,RosaT2072; T2076; T2080; T2081; T2082T2082B; T2082S; T2085; T2086; BA-0101; A2090; T2101; T2102; T2113; T2202T2082S; T2030; T2030A; T2030B; T2030C; T2030D; T2030F; T2030T; T2031; T2031BT208302T2117; T2117AT2117A0T2130; T2131; T2408T2183T2185, AQK1T2190T2203; T2205; T2206; T2207; T2209; T2209A; T2907; T2911T2203A1T2209; T2209B1; T2209C1; TB-002RIW; T100; T205601T2209A1T2212T2302T240101T2402T; T2402C; A2980; D01B+; D01B Plus; D91; D93; D03B; D02B; D905; DAZ-7020; DAZ-7021; DAZ-7022; DAZ-7023T2403T2403A1T2405T2406T2409; T2403B3; T2272; T2422A1; T2407A1; T2460A; T2081A; T2081D; T2205A; T2205C; T2205DT2411T2421T2421D2, AQP, T2421U2, AQ2PT2421T2; AQP2T2422T2423, T2425T2431, T2431A, T2431A0, 679168370T2460T26-BK1T26; T27; T29T27-BK1T27-BK1; T27-WE1; T27-PK1T27-PK1T27-WE1T32-GN2T32-OE2T32-WE2T33-BK2T33-PK2T33-WE2T35-PK2T35-YW2T901TAO Clean Sonic ToothbrushTAO Clean Sonic Toothbrush & Cleaning StationTB-2224WTOOTHBRUSH, POWEREDTRT500; TTP-PCOMBO-W; TTP-STB-1; Triple Bristle; TTP-TB-B; TTP-TB-W; TTP-TRTB-BTTP-TRTB-W; USAAIB2030; USAAIW2030; USAAIW2081; V5731; VGP-1000Umma DiamondUmma Diamond Sonic Toothbrush and Cleaning StationUmma Diamond Toothbrush with UV SanitizerUmma Sonic Toothbrush and Cleaning StationVGP-1001; VGP-1002; Vibrite PK3101; W8273; WF180W; XVR-2097; XVR-2099; XVR-2907VP23264-3400WITBSW5DTZBKRST; WITBSW5DWTRST; XI-Sonic Kids; XI-Sonic Kids; Doodo TB001; RST2115	2009
Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1	—	Maker	LA-327;; Germ Shield; Germ Shield UV Sanitizer For Toothbrushes; RST2010; RST2011; RST2020; RST2031; RST2032; RST2032S;RST2042; RST2043; RST2063C;; RST2072; RST2082; RST2082S; RST2918; RST2937; RST6010; RST6020; RST6021S1; S450-BE DELUXE PLUS; S450-BK DELUXE PLUS; S450-RD DELUXE PLUS; S450-SR DELUXE PLUS; SA008SHE037; TB-002RIW; Vibrite KT6037; WITBSW5DTZBKRST; Tao Clean Germ Shield UV Sanitizer For ToothbrushesU6003; U6005; U6006; ULTRAVIOLET SANITATION/STERILIZATION; Universal Toothbrush SterilizerU6010 UV SanitizerU6067 / BA-0402-WHTULTRAVIOLET SANITATION/STERILIZATIONVIO100VIOlight Toothbrush Sanitizer; COSMICSMILE; DP77180-1100; RST2937 Vibrite Wave; S1; S2; S20; S620 DELUXE; SUPERSMILE 1 more 371107; BA-0401-WHT; CVS77180-1100; D93; DP27144-1100 DP27144-1200 SB27144-1000; DT-001; EKA004; ES1012785; FG6062	2009

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
Shenzhen Risun Technology Co., Ltd.FDA reg. 3007711548	Shenzhen Guangdong, China	Contract manufacturer, Foreign exporter, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10029850). 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.