Resin, Root Canal Filling
Regulation 872.3820
7510(k)s in 12 months (148 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KIF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2016 | Ormco/Sybronendo Sealapex Xpress, Part No. 33639
The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of Terminated |
KIF | K010940 |
| Mar 2, 2010 | Sybron Dental Specialties Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA.
Intended as a root canal filling material that is used in conjunction with gutta percha Terminated |
KIF | K040940 |
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