510(k) K190949
- Device
- ScanX Barrier Envelopes
- Applicant
- Air Techniques Inc.
- 510(k) number
- K190949
- Product code
- PEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-26
- Date received
- 2019-04-11
- Regulation
- 878.4370
- Classification name
- Dental Barriers And Sleeves
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Samir Ghevariya
- Address
- 1295 Walt Whitman Rd. Melville NY US 11747 11747
FDA Registration Numbers#
- 3015491448
- 9680887
- 3038718579
- 3004425647
- 3015276580
- 2435946
- 1051614
- 2024980
- 2320721
- 8032009
- 3027234828
- 2183301
- 2133714
- 3042367543
- 1941138
- 9612352
- 3017910185
- 3007046497
- 3011824442
- 2428225
- 3014683120
- 3006847937
- 8010638
- 2511556
- 3004046477
- 3004966444
- 2029234
- 3010656982
- 3011944170
- 3035858919
- 3025414363
- 2424472
- 8010908
- 3012664306
- 3001468798
- 3005665377
- 2086043
- 3014345250
- 3009307523
- 3024088964
- 3001052305
- 3009496224
- 2437780
- 2515379
- 1718912
- 2182318
- 3010598169
Source Documents#
Other 510(k) Records For Product Code PEM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250735 | Dental Barrier and Sleeves | Fomed Industries, Inc. | 2025-06-10 |
| K250606 | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | 2025-05-29 |
| K242435 | Dental Barrier and Sleeves | Wellmed Dental Medical Supply Co., Ltd. | 2024-10-18 |
| K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | 2024-05-09 |
| K220662 | Disposable Barrier Sleeves | Premium Plus (Dongguan) Limited | 2022-05-11 |
| K211026 | Minitube Dentasleeve Protective Barrier Sleeves | Minitube AB | 2021-08-03 |
| K201604 | Plasdent Disposable Barrier Sleeves and Barrier Film | Plasdent Corporation | 2020-12-23 |
| K191448 | Barrier Sleeves | Ivoclar Vivadent, AG | 2019-10-08 |
| K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019-09-10 |
| K183263 | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | Unipack Medical Corporation | 2019-06-14 |
| K163447 | Premium Plus Disposable Barrier Sleeve | Premium Plus International Limited | 2017-06-20 |
| K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | 2016-06-07 |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Pac-Dent International, Inc. | 2016-03-03 |
| K132953 | TIDISHEILD | Tidi Products,Llc | 2014-02-18 |
Legacy Summary#
summary
FDA Review#
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