The following data is part of a premarket notification filed by Pulpdent Corporation with the FDA for Pulpdent Solo Flowable Composite With Mcp.
| Device ID | K153249 |
| 510k Number | K153249 |
| Device Name: | Pulpdent Solo Flowable Composite With MCP |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Pulpdent Corporation 80 Oakland Street Watertown, MA 02472 |
| Contact | Kenneth J Berk |
| Correspondent | Roger Mastrony MedTek LLC 2516 Kettle Creek Court Lincolnton, NC 28092 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-09 |
| Decision Date | 2016-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D701LLE32 | K153249 | 000 |
| D701SVPFA352 | K153249 | 000 |
| D701SVPFA42 | K153249 | 000 |
| D701SVPFA62 | K153249 | 000 |
| D701SVPFB12 | K153249 | 000 |
| D701SVPFA12 | K153249 | 000 |
| D701SVPFA22 | K153249 | 000 |
| D701SVPFBW2 | K153249 | 000 |
| D701VPF1A12 | K153249 | 000 |
| D701VPF1A22 | K153249 | 000 |
| D701VPF1A32 | K153249 | 000 |
| D701VPF1A352 | K153249 | 000 |
| D701VPF1A42 | K153249 | 000 |
| D701VPF1A62 | K153249 | 000 |
| D701VPF1B12 | K153249 | 000 |
| D701VPF1BW2 | K153249 | 000 |
| D701SVPFA32 | K153249 | 000 |