The following data is part of a premarket notification filed by Dentsply International Inc. with the FDA for Disposable Barrier Sleeves And Covers.
| Device ID | K160232 |
| 510k Number | K160232 |
| Device Name: | Disposable Barrier Sleeves And Covers |
| Classification | Dental Barriers And Sleeves |
| Applicant | DENTSPLY International Inc. 221 West Philadephia Street, Suite 60 York, PA 17408 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY International Inc. 221 West Philadephia Street, Suite 60 York, PA 17408 |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D773660HT46C1 | K160232 | 000 |
| D773660HT46B1 | K160232 | 000 |
| D773660HT45751 | K160232 | 000 |
| D773660HT275241 | K160232 | 000 |
| D773660HT2510H1 | K160232 | 000 |
| D773660HT2510C1 | K160232 | 000 |
| D773660HT15261 | K160232 | 000 |
| D773660HT11161 | K160232 | 000 |
| D773660HT10141 | K160232 | 000 |