Manufacturer registered with FDA

Risun Technology (Shenzhen) Limited

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

FDA owner/operator10094274Contract manufacturerForeign exporterManufacturer

Device types listed: 3
Brands and models: 82
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1China

Devices listed with FDA

What Risun Technology (Shenzhen) Limited 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	AS-ELITE-FLOS F5037AS-FLOS-PRO3, AS-ELITE-FLOS, AS-FLOSAS-ICON-FLOS F5330BA-0160COSLUS C20/CX20 COSLUS EX40, COSLUS C51/CX51, COSLUS CX31 COSLUS EX1, COSLUS C50/CX50COSLUS C31, COSLUS E40, COSLUS E1; D50BS; D50WS; D51; D52; D92; D9201; D9202; D9203; D9204; D9205; D9206; D9207D52-BK2; D9209; D9210; D9211; D951; D952; D953; D954; D955; D956; D957; D958; D959; D960; D961; D962; D963; D964; D965D9208; D52-BE1; D52-BK1; F18-WE2; F18-PK1; F09-WE2; F09-BK1; F18; F18-BK3; F18-WE10; D52-WE3, D52-BK1, D52-WE4DC-03154, F5043; F5039-W, F5039-B, F5052-W, F5052-B; F5047, C50; F5048, F5049, F5052DS-600; EKA001; EKA005; EL-V8; ES1014336; EUAIW5002; F05; F5015A; F5015B; DL-5003; F21; F22-BE2; F22-WE2; F23-DG1 17 more F23-OE2; F29-WE2; F29-GN2; F29-WE3, F29-BK1, A5962, F26, F29; F29-WE4; F29-BK2; F30-BK1; F30-GY1; F32-WE1; F32-BK1F32-BE1; F32; F32-WE2; F32-BK2; F5; F5004; F5003; F5007; F5008; F5010; F500801; F5012; F5013; F5015; F5015A; F5015B;F5020; F5021; F5022; F5101; F5102; F5012D0-EUR-WE90; F5013; F5020; F5020A; F5020BF5020C; F5020D; F5020E; F5020E; F5020E; F5022; F5023; F5025; F5501A; GOI3110W; F5021A; F5021B; F5025A; F5026; F5027;F5028; F5029; F5029A; F5030; F5030A; F5031, F5032, F5035, F5037, F5108; F5038; F5039; F5040; F5041F5102A; F5102A; F5105; F5501; A5901; F5105; F5106; F5105A; F5106A; F5026A; F5026B; F5530C; F5107; F5330; F5530GS28149-0100 DP28149-0100 GS28150-0100 DP28150-0100; HC-T5100; HC-T5300; HOC430; HOC460; HT-1-3; GSX-1; HOC600HOC700; HT-3; IP-1502; IP-1503; JUMOIF01; Kealive; M3; M5102; M5102; MT420; MRPC; OI-100R; OI-100R PLUS; OI-200; OI-320HX3826/21, HX3826/23, HX3826/24, HX3824/21, HX3827/21, HX3822/14, HX3822/11; ZTH-F5029 NEW, ZTH-F5029 PROIT-5106; L-HAO01; BL-HMIRG-550; SI-HMIR-700; Mornwell D52; Mornwell F29,Mornwell F29-BK1,Mornwell F29-WE2J, L, F5339, F5338Mornwell F29-WE3; Mornwell F38; Mornwell F42; OC-001; OC-002; OC-003; OC-010; OC-100; OC-200; OC-300; OI-535; OJ-1200B;OJ-750B; OR-888; OR-F50; P-27; PHWF35WT; R08-0016; RO-110; RO-110-TIP; OI27R; OMIO-100; Oral Irrigation: CX50, W2;OTS101, OTS102; SP-04505; STO-PO2016; STO-PO2016O; STO-PO2016U; STO-RN2SO; STO-RN2SU; TTP-CTI-1; TTP-OI-2; TTP-OI-3TB-2223W; Triple Bristle DC-14; TTP-PCOMBO-W; TTP-PRO1000; TTP-Pro2000b; TTP-Pro2000w; TTP-WFJR-GreenTTP-WFJR-Pink; TTP-PWF-1; TTP-WFJR-Blue; USAAIW5002; VA-EB006; VIP-006; VL-1502; WF150W; WF180W; WFR-100; WI-911WY-5088; UNIT, ORAL IRRIGATION; WIDS4DWTRST; X386W1, HX386M1, HX386B1, HX381W1, HX381M1	2025
Powered ToothbrushJEQ · Class 1	Toothbrushes	Maker	A2767, A2768, A2769AQLCD2, DP2, RST2030TAQP T2421D2BA-0131; BA-0132; BA-0133; BA-0134; BA-0135; BA-0139, BA-0140; BA-0150; BA-0151; BA-0152; BA-0155-WHT; BX-450; D01; D01BClean System; BA-0103-BLK; BA-0103-WHT; BA-0201; AQ1;T2082C; BH2OSUV001; BX-150; BX-250; BX-350; BA-0106; BA-0130COSLUS C30/CX30, 711862, 5445862D01B Plus; D91; D93; D03B; D02B; D905; DAZ-7020; DAZ-7021; DAZ-7022; DAZ-7023; T2403; T2403A1D02; D02B; D02BS; D03; D90; D901; D902; D903; D904; AQ2; DAZ-7024; DAZ-7025; DAZ-7026; DAZ-7042; DAZ-7044; DAZ-7045DAZ-7047; DAZ-7051; DAZ-7053; DAZ-7055; DAZ-7063; DAZ-7065; DAZ-7070-S; DAZ-7070-T; DAZ-7071; DAZ-7072; DAZ-7080-PDAZ-7081; DAZ-7142; DAZ-7144; DAZ-7145; DAZ-7147; DAZ-7180; DC-03175; DM25098-0103; DP23095-1100; DP23095-1200 37 more DP23096-1000; DP23264-0500; DP2; DP23264-4500; DP23264-4600; DP25098-0103; DP25104-0102; DP25105-0102DP25288-0103; DP25289-0103; DP27146-1100; DP27146-1200; DRX-6000; DRX-6000 BH2; DRX-7000DRX10000 Intelisonic; DRX11000; DRX11000 BH2; DRX9000 Revolation; DT-001; EKA002; EKA003Electronic Toothbrush; ES1012785; ES1014746; ES1014877; ES1014964; ER109001; EUAIB2030; EUAIW2030; EUAIW2081; FG6062GEHP191AP-PT; GO9450; GO9501; GS23096-1000; Healthy Clean Sonic 6000; HP-STX; HSD-008; HSD-010; HT-1GO-9301; GO-9450; GO9301; F5501; A2946; S400; S400 DELUXE; S420-BE DELUXE PLUS; S420-BK DELUXE PLUSHT1000; Health Tec.940-10005; Health Tec. 940-10001; HP141A; HP142A; IDDYS-1805-W1, IDDYS-1805-W1KATBRSHUVSA; HP107A; Atmoko; Ellesye; IRM-1; T2026; BA-0150; IT989; LHH-ETB_IB2; M2911; M2916M2206,Rosa; T2072; T2076; T2080; T2081; T2082; T2082B; T2082S; T2085; T2086; BA-0101; A2090Mornwell T37,Mornwell T37-BK1,Mornwell T37-WE1,Mornwell T38,Mornwell T38-BK1,Mornwell T38-WE1Mornwell T39; N-02, N-01, N-15, Slim, C30, CX30; NV-08093; OFI-200; OR-T50; OR-T80; OSUV001; OTR-100; PRO-40MT110C; M2032B; P11; P11plus; Plomo; MT110; Max Clean Sonic 5000; Mornwell A2729; Mornwell T25PSP0814; R08-0018; RBH-01; RBH-8; RBH8-BE; OR3800; P9T2023; RBH8-BK; RBH8-RD; RET200RBH-7 / RST2921 /RBH-8 /RST2090RH-250; RH-350; RS2033D; RS2082B; RS2082B Vibrite Wave; RST2710; S2,D2,K7S,E11,P11,P9,P10,E10,T9,P80,P80SS1, S 1; T2042; T2203A1; T25; TBS28W; TBS31W; TBS40W; T205101; T2412; T2412A1; T2213S420-RD DELUXE PLUS; S430; S450 DELUXE; S450-BE DELUXE PLUS; S450-BK DELUXE PLUSS450-RD DELUXE PLUS; S450-SR DELUXE PLUS; S50; S620; S750; SA008; SB23096-0500; SB23096-1000; SB23096-4500SB23096-4600; SB27146-4500; SB27146-4600; SBS-7180; SFR201; SFR401; SFT050; SFT100; SFT150SFT200; SHE037; Sonic Clean PRO 800; Shinbicare S600; T2028; T2031S; T2032; T2032A; T2032B; T2032S; T2056; T2056S; T2041SOC-SOT T2189T2031; T2031B; T208302; T2117; T2117A; T2117A0; T2130; T2131; T2408; T2183; T2185, AQK1T2101; T2102; T2113; T2202; T2082S; T2030; T2030A; T2030B; T2030C; T2030D; T2030F; T2030TT2203; T2205; T2206; T2207; T2209; T2209A; T2907; T2911; T2203A1; T2209; T2209B1; T2209C1T2205D; T2411; T2421; T2421D2, AQP, T2421U2, AQ2P; T2421T2; AQP2; T2422; T2423, T2425T2232; T2233; T205606; ESHP107ABUS; T205605;AMHP107AB; LA-327; M2032A,Plomo; M2206,AzulT2405; T2406; T2409; T2403B3; T2272; T2422A1; T2407A1; T2460A; T2081A; T2081D; T2205A; T2205CT2460; T26-BK1; T26; T27; T29; T27-BK1; T27-BK1; T27-WE1; T27-PK1; T27-PK1; T27-WE1; T32-GN2T32-OE2; T32-WE2; T33-BK2; T33-PK2; T33-WE2; T35-PK2; T35-YW2; T901; TAO Clean Sonic ToothbrushTAO Clean Sonic Toothbrush & Cleaning Station; TB-2224W; TOOTHBRUSH, POWERED; TRT500; TTP-PCOMBO-W; TTP-STB-1TB-002RIW; T100; T205601; T2209A1; T2212; T2302; T240101; T2402T; T2402C; A2980; D01B+Triple Bristle; TTP-TB-B; TTP-TB-W; TTP-TRTB-B; TTP-TRTB-W; USAAIB2030; USAAIW2030; USAAIW2081Umma Diamond Toothbrush with UV Sanitizer; Umma Sonic Toothbrush and Cleaning StationV5731; VGP-1000; Umma Diamond; Umma Diamond Sonic Toothbrush and Cleaning StationVGP-1001; VGP-1002; Vibrite PK3101; W8273; WF180W; XVR-2097; XVR-2099; XVR-2907; VP23264-3400; WITBSW5DTZBKRSTWITBSW5DWTRST; T2231; T2401; T2402; T2420; T2052C;T2052U; T2083; T2203A1; Z-1080WITBSW5DWTRST; XI-Sonic Kids; XI-Sonic Kids; Doodo TB001; RST2115	2025
Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1	—	Maker	COSMICSMILE; DP77180-1100; RST2937 Vibrite Wave; S1; S2; S20; S620 DELUXE; SUPERSMILELA-327;; Germ Shield; Germ Shield UV Sanitizer For Toothbrushes; RST2010; RST2011; RST2020; RST2031; RST2032; RST2032SRST2042; RST2043; RST2063C;; RST2072; RST2082; RST2082S; RST2918; RST2937; RST6010; RST6020; RST6021; S1S450-BE DELUXE PLUS; S450-BK DELUXE PLUS; S450-RD DELUXE PLUS; S450-SR DELUXE PLUSSA008; SHE037; TB-002RIW; Vibrite KT6037; WITBSW5DTZBKRST; Tao Clean Germ Shield UV Sanitizer For ToothbrushesU6003; U6005; U6006; ULTRAVIOLET SANITATION/STERILIZATION; Universal Toothbrush SterilizerU6010 UV Sanitizer; ULTRAVIOLET SANITATION/STERILIZATION; VIO100; VIOlight Toothbrush Sanitizer371107; BA-0401-WHT; CVS77180-1100; D93; DP27144-1100 DP27144-1200 SB27144-1000; DT-001; EKA004; ES1012785; FG6062	2025

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
RISUN TECHNOLOGY (SHENZHEN) LIMITEDFDA reg. 3042262535	Shenzhen Guangdong, China	Contract manufacturer, Foreign exporter, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10094274). 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.