Plasdent
The Plasdent filing describes disposable polyethylene barriers in different shapes and sizes for dental instruments and equipment. The listed PS400 is identified in the filing as a computer…
The Plasdent filing describes disposable polyethylene barriers in different shapes and sizes for dental instruments and equipment.
The listed PS400 is identified in the filing as a computer cover for a keyboard, placing it among the covered equipment accessories.
Listed Item
A/T Soft Barrier Envelopes, East-Tear, For Phosphor Plates, Long Side Opening, #0
Barrier Use
The filing describes the sleeves as covers for small dental instruments and the film covers as equipment barriers. Products are non-sterile, disposable and intended for one patient and one time use.
12manufacturers in China registered for this device type
152catalogue numbers in this listing
1510(k) clearance
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 | Plasdent Corp., United States |
|---|---|
| FDA product code | PEM |
| Device type | Dental Barriers And Sleeves |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| 510(k) | K201604 |
| Record published | 2022-03-25 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Packaging | Case of 20, case of 4, case of 100, case of 12, case of 8, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PS110 | 100 | In distribution | |
| PS-GXDR-1 | 500 | In distribution | |
| PS400 | 250 | In distribution | |
| ST2002 | 100 | In distribution | |
| PS321 | 500 | In distribution | |
| IC-20810 | 500 | In distribution | |
| PS900 | 3,000 | In distribution | |
| PS1250M | 1,200 | In distribution | |
| PS700 | 500 | In distribution | |
| PS-DEXIS-U | 500 | In distribution | |
| XS-SHICK-2 | 500 | In distribution | |
| PS106 | 150 | In distribution | |
| PS-REGAM-2 | 500 | In distribution | |
| XS-6100-1 | 500 | In distribution | |
| PS4500 | 200 | In distribution | |
| PS204 | 500 | In distribution | |
| IC-20856 | 500 | In distribution | |
| PS1250Y | 1,200 | In distribution | |
| PS-002 | 500 | In distribution | |
| PS901 | 250 | In distribution | |
| SS100 | 500 | In distribution | |
| PS3800 | 225 | In distribution | |
| PS-DEMI | 400 | In distribution | |
| BE-003S | 100 | In distribution | |
| PS-CYGNUS-1 | 500 | In distribution | |
| PS-LED | 250 | In distribution | |
| PS310 | 500 | In distribution | |
| BEAT-000S | 100 | In distribution | |
| PS4708 | 500 | In distribution | |
| PS320A | 500 | In distribution | |
| IC-20964 | 500 | In distribution | |
| PS-6100-2 | 500 | In distribution | |
| BE-004S | 50 | In distribution | |
| PS3767-WO | 500 | In distribution | |
| PS-SHICK-1 | 500 | In distribution | |
| PS530 | 500 | In distribution | |
| XS-REGAM-2 | 500 | In distribution | |
| SS200 | 500 | In distribution | |
| PS202 | 500 | In distribution | |
| PS1105 | 500 | In distribution | |
| PS1250B | 1,200 | In distribution | |
| PS200 | 500 | In distribution | |
| ST4004 | 100 | In distribution | |
| IC-20805 | 500 | In distribution | |
| IC-20909 | 500 | In distribution | |
| PS-GXDR-2 | 500 | In distribution | |
| PS540 | 500 | In distribution | |
| PS-5505 | 500 | In distribution | |
| PS405 | 500 | In distribution | |
| IC-20911 | 500 | In distribution | |
| PS-DEXIS-2 | 500 | In distribution | |
| BEE-000 | 100 | In distribution | |
| PS203 | 500 | In distribution | |
| PS3740 | 1,200 | In distribution | |
| PS-00/01 | 500 | In distribution | |
| PS-6100-1 | 500 | In distribution | |
| BEE-001 | 100 | In distribution | |
| PS2800 | 250 | In distribution | |
| PS-6100-0 | 500 | In distribution | |
| PS328 | 1,000 | In distribution | |
| PS370 | 250 | In distribution | |
| PS1250O | 1,200 | In distribution | |
| BE-000S | 100 | In distribution | |
| PS425 | 250 | In distribution | |
| CL-101 | 500 | In distribution | |
| XS-DEXIS-2 | 500 | In distribution | |
| PS410-ST | 250 | In distribution | |
| PS4700 | 500 | In distribution | |
| ST3003 | 100 | In distribution | |
| BEE-002 | 100 | In distribution | |
| PS-SUNI-2 | 500 | In distribution | |
| PS308 | 500 | In distribution | |
| PS3850 | 125 | In distribution | |
| PS-5533 | 500 | In distribution | |
| PS101 | 250 | In distribution | |
| XS-CYGNUS-1 | 500 | In distribution | |
| BE-002S | 100 | In distribution | |
| PS670 | 250 | In distribution | |
| BEAT-001S | 100 | In distribution | |
| XS-DEXIS-U | 500 | In distribution | |
| PS201 | 500 | In distribution | |
| XS-GXDR-2 | 500 | In distribution | |
| PS1250C-B | 1,200 | In distribution | |
| PS1250P | 1,200 | In distribution | |
| IC-20917 | 500 | In distribution | |
| PS1250G | 1,200 | In distribution | |
| PS102 | 300 | In distribution | |
| PS1250E | 1,200 | In distribution | |
| PS710 | 500 | In distribution | |
| PS400-S | 250 | In distribution | |
| PS500 | 1,000 | In distribution | |
| PS735 | 500 | In distribution | |
| PS370LG | 250 | In distribution | |
| PS903 | 250 | In distribution | |
| PS1270C | 800 | In distribution | |
| PS320 | 500 | In distribution | |
| PS-5500 | 500 | In distribution | |
| XS-6100-2 | 500 | In distribution | |
| PS328P | 500 | In distribution | |
| PS1250B-B | 1,200 | In distribution | |
| THS0808 | 300 | In distribution | |
| HP-COVR | 100 | In distribution | |
| IC-085 | 500 | In distribution | |
| IC-20987 | 500 | In distribution | |
| PS902 | 250 | In distribution | |
| PS4550 | 400 | In distribution | |
| PS-5522 | 500 | In distribution | |
| PS-SHICK-2 | 500 | In distribution | |
| PS510 | 1,000 | In distribution | |
| IC-20969 | 500 | In distribution | |
| IC-001 | 500 | In distribution | |
| PS3720 | 1,200 | In distribution | |
| CL-100 | 500 | In distribution | |
| PS900BG | 250 | In distribution | |
| PS3800FT | 225 | In distribution | |
| PS300 | 500 | In distribution | |
| PS328T | 500 | In distribution | |
| XS-SHICK-1 | 500 | In distribution | |
| PS650 | 250 | In distribution | |
| PS105 | 200 | In distribution | |
| XS-6100-0 | 500 | In distribution | |
| PS325 | 500 | In distribution | |
| BE-001S | 100 | In distribution | |
| PS520 | 500 | In distribution | |
| PS4660 | 250 | In distribution | |
| IC-20855 | 500 | In distribution | |
| PS720 | 500 | In distribution | |
| PS4511 | 200 | In distribution | |
| PS-5511 | 500 | In distribution | |
| IC-21013 | 500 | In distribution | |
| XS-SUNI-2 | 500 | In distribution | |
| ST6006 | 100 | In distribution | |
| XS-GXDR-1 | 500 | In distribution | |
| PS410 | 250 | In distribution | |
| PS660 | 250 | In distribution | |
| PS1230C | 600 | In distribution | |
| PS-5502 | 250 | In distribution | |
| PS3825 | 200 | In distribution | |
| THS1610 | 300 | In distribution | |
| PS3850FT | 125 | In distribution | |
| BEAT-002S | 100 | In distribution | |
| PS730 | 500 | In distribution | |
| PS1250C | 1,200 | In distribution | |
| CL-102 | 500 | In distribution | |
| PS1100 | 300 | In distribution | |
| PS4701 | 500 | In distribution | |
| PS327 | 500 | In distribution | |
| PS408 | 250 | In distribution | |
| PS4707 | 250 | In distribution | |
| IC-20829 | 500 | In distribution | |
| THS1182 | 300 | In distribution | |
| PS-5501 | 500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Patient Armor Barriers | American Hospital Supply | 10 |
Showing 12 of 154. All products under Dental Barriers And Sleeves
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201604 | 2020-12-23 |
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.