PRE-Klenz
Pre-Klenz Enzymatic Soak Shield Kit is used to keep contaminated instruments moist during transportation for up to 72 hours
48manufacturers in China registered for this device type
4catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (26), Zhejiang (7), Jiangsu (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Heearly Technology Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 13 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Xiamen Atyou Health Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
Showing 12 of 48. All 48 manufacturers in China registered for Cleaner, Ultrasonic, Medical Instrument
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | FLG |
| Device type | Cleaner, Ultrasonic, Medical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6150 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-03-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2D66J4 | 250 | In distribution | |
| 2D66Q5 | In distribution | ||
| 2D66J6 | 25 | In distribution | |
| 2D66J3 | 250 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioSonic | Coltene/Whaledent Gmbh & Co. KG | 49 |
| Prolystica | Steris Corporation | 41 |
| Ultra Clean Systems | Getinge Disinfection AB | 33 |
| Henry Schein | Henry Schein, Inc. | 33 |
| Steelco | Steelco SPA | 16 |
| BrandMax Tri-Clean | Brandmax | 12 |
| Alconox | Alconox, LLC | 11 |
| Valsure | Steris Corporation | 11 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 10 |
| Detojet | Alconox, LLC | 9 |
| Liquinox | Alconox, LLC | 8 |
| Citranox | Alconox, LLC | 8 |
Showing 12 of 834. All products under Cleaner, Ultrasonic, Medical Instrument
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-11-19 | Class II | Device Design | STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to u | 23,445 units, Domestic 5,727 units, Foreign 17,718 units | 2023-10-25 |
| 2020-06-26 | Class II | Process control | A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. | 1283 | 2020-12-22 |
| 2006-06-22 | Not classified | Other | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire. | 322 units | 2007-01-08 |
| 2006-06-22 | Not classified | Other | Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire. | 353 units | 2007-01-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.