The following data is part of a premarket notification filed by Dentsoll, Inc. with the FDA for Acrytone, Rezen Nf, And Iso Fast Denture Resins.
| Device ID | K130680 |
| 510k Number | K130680 |
| Device Name: | ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTSOLL, INC. 8708 CAPEHART COVE Austin, TX 78733 |
| Contact | David C Furr |
| Correspondent | David C Furr DENTSOLL, INC. 8708 CAPEHART COVE Austin, TX 78733 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2013-07-26 |
| Summary: | summary |