The following data is part of a premarket notification filed by Air Techniques Inc. with the FDA for Scanx Barrier Envelopes.
| Device ID | K190949 |
| 510k Number | K190949 |
| Device Name: | ScanX Barrier Envelopes |
| Classification | Dental Barriers And Sleeves |
| Applicant | Air Techniques Inc. 1295 Walt Whitman Road Melville, NY 11747 |
| Contact | Samir Ghevariya |
| Correspondent | Samir Ghevariya Air Techniques Inc. 1295 Walt Whitman Road Melville, NY 11747 |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-11 |
| Decision Date | 2019-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E247732482 | K190949 | 000 |
| E247732480 | K190949 | 000 |
| D6787324801 | K190949 | 000 |