# K053580: Doctor's Nightguard

- Pathway: 510(k) (Traditional)
- Applicant: Dental Concepts, LLC
- Decided: Mar 3, 2006 after 71 days
- Product code: MQC (Mouthguard, Prescription)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
62 later devices descend from it; 8 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dental Concepts BruxGuard: named in the summary without a submission number
- (no number) Hollywood Products Mouth Peace: named in the summary without a submission number
- (no number) GEM Scientific Products, Inc. Tension Reliever: named in the summary without a submission number

## Most influential descendants
- K063483: Den Tek Nightguard (2007), 31 descendants of its own
- K072147: Den Tek Comfort Fit Nightguard (2007), 19 descendants of its own
- K073220: The Doctor's Nightguard Advanced Comfort (2007), 17 descendants of its own
- K082723: Grindguard (2009), 10 descendants of its own
- K083400: Custom Comfort Nightguard (2008), 10 descendants of its own

## Indications for use
The Doctor's NightGuard is indicated for prottection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teoth and to prevent the noise associated with bruxing or grinding.

Source page: https://510kreport.com/device/K053580
Methodology: https://510kreport.com/methodology