Valo™ Barrier Sleeves
Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchants and other chemistry, and are highly important for keeping…
Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient’s tissues, as well as etchants and other chemistry, and are highly important for keeping your VALO curing light sanitary. Barrier sleeves are available in three sizes to fit VALO™ X, VALO™ Grand, and VALO™ Corded/Cordless curing lights. Prevents direct contact between your VALO curing light and the patient’s tissues Protects your VALO curing light from direct contact with etchants and other chemistry Important for maintaining sanitary conditions Available in three sizes
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 | Minitube AB, Sweden |
|---|---|
| FDA product code | PEM |
| Device type | Dental Barriers And Sleeves |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K211026 |
| Record published | 2024-05-01 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Wrapped bundle of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| VALO Cordless 600 Barrier Sleeves Refill | 300 | In distribution | |
| VALO X 600 Barrier Sleeves Refill | 300 | In distribution | |
| VALO Corded 600 Barrier Sleeves Refill | 300 | 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 |
| iSmile | Ismile Dental Products Inc. | 19 |
| 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 |
Showing 12 of 154. All products under Dental Barriers And Sleeves
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211026 | 2021-08-03 |
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.