Ismile
Curing Light Sleeve 13-1/2" x 3-1/4" 3/4" Tip
12manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (3), Hubei (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Tianjin Water Source Tech Co., Ltd. | Tianjin | Tianjin | Manufacturer | 27 |
| Fomed Industries Inc | Qian Jiang | Hubei | Contract manufacturer | 19 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Yueying Medical Instruments (Langfang) Co., Ltd. | Langfang | Hebei | Contract manufacturer | 9 |
| Yongqing Huaguan Dental Instruments Factory | Langfang | Hebei | Contract manufacturer | 9 |
Record
| Listed by | Ismile Dental Products Inc., United States |
|---|---|
| FDA product code | PEM |
| Device type | Dental Barriers And Sleeves |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Repacker / relabeller |
| 510(k) | K190484 |
| Record published | 2023-06-21 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 65-6010 | 500 | In distribution | |
| 45-0025 | 500 | In distribution | |
| 25-3011 | 250 | In distribution | |
| 45-0036 | 125 | In distribution | |
| 25-3010 | 250 | In distribution | |
| 45-0030 | 225 | In distribution | |
| 45-0010 | 500 | In distribution | |
| 45-0001 | 1,200 | In distribution | |
| 45-0045 | 500 | In distribution | |
| 45-0009 | 500 | In distribution | |
| 45-0060 | 275 | In distribution | |
| 65-6005 | 500 | In distribution | |
| 65-6015 | 500 | In distribution | |
| 45-0002 | 1,200 | In distribution | |
| 45-0026 | 500 | In distribution | |
| 45-0050 | 500 | In distribution | |
| 45-0040 | 500 | In distribution | |
| 45-0041 | 500 | In distribution | |
| 45-0015 | 500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plasdent | Plasdent Corp. | 152 |
| Premium Plus | Premium Plus (Dongguan) Limited | 61 |
| Premium Plus | Premium Plus International Limited | 59 |
| Pac-Dent | PAC-Dent Inc. | 44 |
| JMU | JMU Dental, Inc | 42 |
| MARK3 | Cargus International, Inc | 26 |
| Rinn® | Dentsply LLC | 25 |
| ScanX Barrier Envelopes | AIR Techniques, Inc. | 13 |
| Tidishield | Tidi Products, LLC | 12 |
| Phosphor Plate Barrier Envelopes | Maxill, Inc. | 12 |
| Benco | Benco Dental Supply Co. | 10 |
| Patient Armor Barriers | American Hospital Supply | 10 |
Showing 12 of 154. All products under Dental Barriers And Sleeves
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.