The following data is part of a premarket notification filed by Scientifica Pharmaceuticals with the FDA for Dfv Desensitizing Varnish-strawberry Flavor, Dfv Desensitizing Varnish-bubblegum (tutti-fruity) Flavor, Dfv Desensitizing Varnish-spearmint Flavor, Dfv Desensitizing Varnish-chocolate Flavor, Dfv Desensitizing Varnish-marshmallow Flavor.
| Device ID | K192381 |
| 510k Number | K192381 |
| Device Name: | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor |
| Classification | Varnish, Cavity |
| Applicant | Scientifica Pharmaceuticals 3221 Producer Way Pmona, CA 91768 |
| Contact | Thomas Kelly |
| Correspondent | Thomas Kelly Scientifica Pharmaceuticals 3221 Producer Way Pmona, CA 91768 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2020-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP70201 | K192381 | 000 |
| D801SP70221 | K192381 | 000 |
| D801SP70231 | K192381 | 000 |
| D801SP70241 | K192381 | 000 |
| 00850006606061 | K192381 | 000 |
| 00850006606078 | K192381 | 000 |
| 00850006606085 | K192381 | 000 |
| 00850006606139 | K192381 | 000 |
| 00850006606108 | K192381 | 000 |
| 00850006606146 | K192381 | 000 |
| 00850006606115 | K192381 | 000 |
| 00850006606122 | K192381 | 000 |
| 00850006606009 | K192381 | 000 |
| 00850006606092 | K192381 | 000 |
| D801SP70211 | K192381 | 000 |