Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (K243777)
Description
Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) by Theodent, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243777
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (K243777) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K140481 | COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-REL... | Colgate-Palmolive Company | 2014 |
| K132109 | ENAMELAST | Ultradent Products Inc. / Oratech, LLC | 2013 |
| K082594 | REMESENSE | Remedent NV | 2009 |
| K080228 | ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH | Novamin Technology, Inc. | 2008 |
| K080249 | FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 | Ultradent Products, Inc. | 2008 |
Trace the full predicate network for K243777
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.