510(k) K252485— ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
Substantially Equivalent1987 Media Limited
Summary
ClenchNoMore is a dental mouthguard-style appliance, filed in three sizes (Large, Small, Mixed). Product code OBR covers preformed night guards and related oral-appliance products used to manage bruxism (tooth grinding).
Panel assignment shows "Unknown" in our data but OBR is a Dental-panel code. Traditional 510(k). The naming suggests this is a branded over-the-counter or minimally-prescribed consumer-facing bruxism appliance rather than a custom-fabricated orthodontic device. OBR is a crowded category with many small entrants.
1987 Media Limited files from Walton-On-Thames, UK. Eight-month review clock, somewhat long for OBR, which may reflect the applicant's newer-entrant status on this product code.
Clearance details
- Applicant
- 1987 Media Limited
- Product code
- Code OBR
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walton-On-Thames, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.