FDA.reportPublic FDA data

SleepRight

Primary DI
00692121032062
Brand
SleepRight
Company
Splintek Inc.
Model
Ultra-Comfort
Device description
The SleepRight Ultra-Comfort Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00692121032062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00692121032062006921210320626921210320620692121032062

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made mouthguardA custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
171967797
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00692121032055SleepRightSecure-Comfort2025-12-17
00692121032246SleepRightDura-Comfort2025-12-17
00692121035438SleepRightSelect-Comfort2025-12-17
00692121035513SleepRightSnore Aid2025-12-17
00692121035216SleepRightProRx2023-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810036601252Zero GrindDental Choice Holdings LLCOBR2026-10-20
00810036601344CustMbiteDental Choice Holdings LLCOBR2026-10-20
00810036601795Rest In PeaceDental Choice Holdings LLCOBR2026-10-20
00810036602020Rest In PeaceDental Choice Holdings LLCOBR2026-10-20
00810036602457Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036602525Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036602532Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036603676Disco DreamsDental Choice Holdings LLCOBR2026-10-20
00810036603683Disco DreamsDental Choice Holdings LLCOBR2026-10-20
00810036604574KloudDental Choice Holdings LLCOBR2026-10-20
00810036604796Rest In PeaceDental Choice Holdings LLCOBR2026-10-20
00810036604802Rest In PeaceDental Choice Holdings LLCOBR2026-10-20
00810036604956Protect The CrownDental Choice Holdings LLCOBR2026-10-20
00810036604963Protect The CrownDental Choice Holdings LLCOBR2026-10-20
00810036606127KloudDental Choice Holdings LLCOBR2026-10-20
00810036606721BruxArmorDental Choice Holdings LLCOBR2026-10-20
00810036606738BruxArmorDental Choice Holdings LLCOBR2026-10-20
00810036608992Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036609005Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036609012Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810180630924CustMbiteDental Choice Holdings LLCOBR2026-10-20
00810180631013BruxArmorDental Choice Holdings LLCOBR2026-10-20
00810180631020Just SmileDental Choice Holdings LLCOBR2026-10-20
00810180631037Just SmileDental Choice Holdings LLCOBR2026-10-20
00810180631044Just SmileDental Choice Holdings LLCOBR2026-10-20
00810180631914ResolveDental Choice Holdings LLCOBR2026-10-20
00810180631921ResolveDental Choice Holdings LLCOBR2026-10-20
00810180631938ResolveDental Choice Holdings LLCOBR2026-10-20
00850018499316DreamEZDental Choice Holdings LLCOBR2026-10-20
00850018499323DreamEZDental Choice Holdings LLCOBR2026-10-20