Prosthetic devices · 21 CFR 872 Subpart D
Mechanical Denture Cleaner
FDA device type “Cleaner, Denture, Mechanical”.
- Companies listing it
- 3422 makers
- Brands and models
- 36
- 510(k) clearances
- 140 in five years
- FDA name
- Cleaner, Denture, Mechanical
510(k) clearances per year, 1976–2026
Companies that list JER
34 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Premier Dental Products Company | United States | Maker | Pro Clean | 28 | 2026 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Ultrasonic Cleaner - denture | 2 | 2026 |
| Prestige Brands Holdings, Inc. | United States | Maker | Efferdent Denture Bath Kit | 1 | 2013 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | denture cleaner | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Retainer Storage Case/Retainer Box/Denture Box | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Shenzhen YiGuangNian Innovation Technology Co., Ltd. | China | Maker | Cleaner, Denture, Mechanical - Electric Tooth Cleaner:XPRE151,XPRE152,XPRE174; · Electric Tooth Cleaner XPRE176, Electric Tooth Cleaner XPRE178 Electric Ear Cleaner XPRE323 XPRE330 · Teeth Cleaner XPRE146 IFAN042; XPRE058 Makeup Brush Cleanser,XPRE127 Electric Tooth Cleaner, · XPRE128 Electric Tooth Cleaner, IFAN059-IFAN060 XPRE151 XPRE174 Electric Tooth Cleaner | — | — |
| Shenzhen Balinda Technology Co.,Ltd | China | Maker | Ultrasonic Cleaner/Ultrasonic Retainer Cleaner/Ultrasonic Denture Cleaner | — | — |
| Dongguan MiQiang Technology Co., Ltd | China | Maker | Cleaner, Denture, Mechanical - Electric Tooth Cleaner: XPRE151,XPRE174 · Electric Tooth Cleaner, XPRE151 XPRE174, Electric Tooth Cleaner Cleaner, Denture, Mechanical · XPRE058 Makeup Brush Cleanser, XPRE127 Electric Tooth Cleaner: XPRE128, | — | — |
| Renfert GmbH | Germany | Maker | Sympro | — | — |
| Dongguan Mingchuangyoushang Electronic Technology Co., Ltd. | China | Maker | Retainer Cleaner Machine MYT1 | — | — |
| Shenzhen Xiazhifeng Electronic Co., Ltd | China | Maker | Whiten teeth faster | — | — |
| iSonic Inc. | United States | Maker | iSonic® Ultrasonic Denture Retainer Cleaner | — | — |
| Braebon Medical Corporation | Canada | Maker | CPAPFresh · OrthoFresh | — | — |
| Kiyoujochugiku Co., Ltd | Japan | Maker | Dent Clear | — | — |
| AOJ HEALTH Technology Co., Ltd. | China | Maker | Ultrasonic Cleaner USC-10 · Ultrasonic Cleaner USC-20 | — | — |
| Shenzhen Rainbow Technology Co.,Ltd | China | Maker | Ultrasonic Braces cleaner,retainer cleaner denture cleaner RB-038, RB-038B,RB-038C,RB-038D | — | — |
| Teamwork Packaging, Inc. | United States | Maker | CPAPFresh · OrthoFresh | — | — |
| Changsha GOMECY Electronics Co., Ltd. | China | Maker | Plasma Machine:GMS PM 01, GMS PM 02, GMS PM 03, GMS PM 04, GMS PM 05. GMS A59, GMS B59 | — | — |
| Diversified Chemical Products, Inc. | United States | Maker | ProClean | — | — |
| Ecolab Inc | United States | Maker | — | — | — |
| Unette Corporation | United States | Maker | — | — | — |
| Dentsply Sirona, Inc. | United States | Contract manufacturer | — | 148 | 2026 |
| Astron Dental Corporation | United States | Repacker / relabeler | Duraclean Denture Cleaner · Duraclean II Denture Cleaner | 5 | 1987 |
| Valplast Intl. Corp. | United States | Manufacturer | Denture Sonic | 1 | 2006 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Retainer Box, Denture Box | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Pro Clean Stain Cleaner | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| GEODIS Logistics | United States | Repacker / relabeler | Efferdent | — | — |
| Platinum Focus Group Ltd. | United Kingdom | Foreign exporter | Y Connector Prismaflex Box of 50 | — | — |
| Veridian Healthcare | United States | Repacker / relabeler | 19-030 Theracare Ultrasonic Oral Appliance | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 25 Oct 1988 | K883403 | DENTA PLUS | Connoisseurs Products Corp. |
| 26 Aug 1988 | K881391 | ULTRASONIC DENTURE CLEANER | Tatung Company of America, Inc. |
| 11 Aug 1987 | K872521 | DENTURE CLEANSERS | Dental Research Laboratories |
| 31 Jul 1985 | K852906 | DURACLEAN DENTURE CLEANER | Astron Dental Corporation |
| 30 Mar 1984 | K840805 | ORAL SAFE | Great Lakes Orthodontics, Ltd. |
| 26 Sep 1983 | K832359 | ORAL SAFE | Great Lakes Orthodontics, Ltd. |
| 12 Sep 1983 | K832387 | DENTURE CLEANER | Tower Laboratories, Ltd. |
| 17 Mar 1980 | K800166 | DENTSPLY DENTURE CLEANER | Dentsply Intl., Inc. |
| 27 Dec 1979 | K792530 | PLAQUE-X DENTURE CLEANER | Nexell Corp. |
| 26 Oct 1979 | K791925 | DEN-MAT 4-MINUTE DENTURE CLEANER | Den-Mat Corp. |
| 23 Oct 1979 | K791716 | PLAQUE-X DENTURE CLEANSER | Noxell |
| 8 Nov 1978 | K781779 | SANI-DENT DENTURE CLEANER | Sandi-Dent |
| 9 Mar 1978 | K780254 | DENTURE CLEANSER & TOOTHPASTE IN ONE | Richardson Merrel, Inc. |
| 23 Feb 1978 | K780174 | ORABRITE | Norcliff Thayer, Inc. |
Official records: FDA product classification for JER · 21 CFR 872.3530.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026