ClenchNoMore

Primary DI
05060687651907
Brand
ClenchNoMore
Company
1987 MEDIA LIMITED
Model
CNM-L (Large size)
Catalog number
CNM-L
Device description
ClenchNoMore is an over the counter (OTC) device intended to be used by lay people in the home environment for protection against the effects of night-time teeth grinding. The one-piece guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by moulding the bite pads of the guard to the user's teeth after the guard has been heated via submersion in boiled water. The moulding of the thermoplastic material provides a personalised fit for the user. The fully occlusive guard is worn on the teeth, maintaining separation between the upper and lower teeth, thereby reducing the noise and damage associated with teeth grinding. ClenchNoMore is intended for individuals age 18 and older.
Published
2026-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBRMouthguard, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBRMouthguard, Over-The-CounterUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252485000ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media Limited2026-04-10OBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060687651907PrimaryGS10
05060687652591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060687651907050606876519075060687651907
05060687652591050606876525915060687652591

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, reusableA prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+18014491648support@thesleepguard.com

Regulatory Flags#

DUNS number
225773974
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060687651877ClenchNoMoreCNM-1 (Mixed sizing)CNM-12026-07-17
05060687651891ClenchNoMoreCNM-S (Small size)CNM-S2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060687651877ClenchNoMore1987 MEDIA LIMITEDOBR2026-07-17
05060687651891ClenchNoMore1987 MEDIA LIMITEDOBR2026-07-17
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