Class Class U
Dentemp Pro-Comfort Dental Guard (K250456)
Description
Dentemp Pro-Comfort Dental Guard by Doc Brands, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK250456
Clearance Date2025-05-19
Clearance TypeTraditional
Product CodeOBR
FDA Database
View on FDA DatabasePredicate lineage for K250456
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. Dentemp Pro-Comfort Dental Guard (K250456) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K150492 | Ora-GUARD Dental Grind Guard | Bite Tech, Inc. | 2016 |
| K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 | Den Tek Oral Care, Inc. | 2009 |
Trace the full predicate network for K250456
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.