Isolite Moutpiece
Mouthpiece, Bulk (144), Original Pediatric
68manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (11), Shanghai (10), Anhui (9). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Dacheng Huaguan Dental Instruments Co., Ltd. | Langfang | Hebei | Contract manufacturer | 4 |
| Changzhou Shengjie Medical Product Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| EG-Medacys Devices(Shenzhen)Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Kingod Silicone Rubber Products Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 68. All 68 manufacturers in China registered for Mouthpiece, Saliva Ejector
Record
| Listed by | Zyris, Inc., United States |
|---|---|
| FDA product code | DYN |
| Device type | Mouthpiece, Saliva Ejector |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-24 |
| Record revised | 2024-04-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 55 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CIL0701 | 10 | In distribution | |
| CIL0902 | 144 | In distribution | |
| CIL0803 | 100 | In distribution | |
| CIL0301 | 10 | In distribution | |
| CIL0602 | 144 | In distribution | |
| CIL0101 | 10 | In distribution | |
| CIL0501 | 10 | In distribution | |
| CIL0702 | 144 | In distribution | |
| CIL1101 | 10 | In distribution | |
| CIL0901 | 10 | In distribution | |
| CIL1102 | 144 | In distribution | |
| CIL0503 | 100 | In distribution | |
| CIL0601 | 10 | In distribution | |
| CIL0401 | 10 | In distribution | |
| CIL0703 | 100 | In distribution | |
| CIL0201 | 10 | In distribution | |
| CIL0102 | 144 | In distribution | |
| CIL0603 | 100 | In distribution | |
| CIL0801 | 10 | In distribution | |
| CIL1103 | 100 | In distribution | |
| CIL0802 | 144 | In distribution | |
| CIL0302 | 144 | In distribution | |
| CIL0903 | 100 | In distribution | |
| CIL0502 | 144 | In distribution | |
| CIL0202 | 144 | In distribution | |
| CIL0103 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Monoart | Euronda SPA | 24 |
| Physics Forceps | Directa AB | 15 |
| Henry Schein | Henry Schein, Inc. | 13 |
| JMU | JMU Dental, Inc | 12 |
| Top Quality Manufacturing | TOP Quality Manufacturing, Inc. | 12 |
| Acutips | Plasdent Corp. | 11 |
| Medicom Safebasics | AMD Medicom Inc. | 11 |
| DryShield | Solmetex, LLC | 9 |
| Saliva Ejectors With Affixed TIP | Maxill, Inc. | 8 |
| iSmile | Ismile Dental Products Inc. | 8 |
| Flexjet | Plasdent Corp. | 7 |
| Bosworth Flexo | Keystone Industries | 7 |
Showing 12 of 290. All products under Mouthpiece, Saliva Ejector
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.