ScanX Barrier Envelopes
ScanX Barrier Envelopes cover Air Techniques intraoral phosphor storage plates during dental imaging. Each envelope has clear and black polyethylene film layers sealed on three edges. An…
ScanX Barrier Envelopes cover Air Techniques intraoral phosphor storage plates during dental imaging. Each envelope has clear and black polyethylene film layers sealed on three edges. An adhesive strip closes the fourth edge to form the temporary barrier around the plate.
The envelopes are supplied nonsterile for one patient and one use, then discarded. Sizes 0 to 4 match different plate dimensions. Standard and side-loading versions have separate dimensions and part numbers, so the envelope is selected for the plate and loading configuration.
Listed Item
An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images. They also prevent cross contamination between patients.
Size 2 Packaging
The standard size 2 envelope measures 1.73 by 1.32 inches and is offered in boxes of 300 or 1,000. The size 2 side-loading envelope measures 1.75 by 1.34 inches. These are disposable covers rather than the reusable imaging plate itself.
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 | AIR Techniques, Inc., United States |
|---|---|
| FDA product code | PEM |
| Device type | Dental Barriers And Sleeves |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K190949 |
| Record published | 2019-08-26 |
| Record revised | 2023-09-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Box of 1000 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 73248-4 | In distribution | |
| G8511-2C | In distribution | |
| 73248-2 | In distribution | |
| G8511-0 | In distribution | |
| G8511-2 | In distribution | |
| G8511-2K | In distribution | |
| G8511-1 | In distribution | |
| G8511-4 | In distribution | |
| 73248-2K | In distribution | |
| G8511-3 | In distribution | |
| 73248-0 | In distribution | |
| 73248-1 | In distribution | |
| 73248-3 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190949 | 2019-07-26 |
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.