FDA.reportPublic FDA data

LunaGuard

Primary DI
00033732010306
Brand
LunaGuard
Company
McKeon Products, Inc.
Model
Nighttime Dental Guard
Catalog number
1030
Published
2022-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K191033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191033000LunaGuard Nighttime Dental ProtectorMckeon Products2019-08-05OBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00033732010306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00033732010306000337320103060337320103060033732010306

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006522122
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00033732000789Mack'sPillow Soft Silicone Putty Earplugs7T2025-08-05
00033732007122Mack'sPillow Soft Silicone Putty Earplugs7122025-08-05
00033732007184Mack'sPillow Soft Silicone Putty Earplugs7182025-08-05
00033732100786Mack'sPillow Soft Silicone Putty Earplugs7T2025-08-05
00033732107129Mack'sPillow Soft Silicone Putty Earplugs7122025-08-05
00033732107181Mack'sPillow Soft Silicone Putty Earplugs7182025-08-05
00033732000055Mack'sPillow Soft Silicone Putty Earplugs52022-10-07
00033732000062Mack'sPillow Soft Silicone Putty Earplugs (Orange)62022-10-07
00033732000086Mack'sPillow Soft Silicone Putty Earplugs (Beige)82022-10-07
00033732000109Mack'sKids Size Soft Moldable Silicone Putty Earplugs102022-10-07
00033732002004Mack'sPillow Soft Silicone Putty Earplug Dispenser2002022-10-07
00033732002066Mack'sPillow Soft Silicone Putty Earplug Dispenser (Oran2062022-10-07
00033732002080Mack'sPillow Soft Silicone Putty Earplug Dispenser (Beig2082022-10-07
00033732002103Mack'sKids Size Moldable Silicone Putty Earplug Dispense2102022-10-07
00033732010153Mack'sKids Size Soft Moldable Silicone Putty Earplugs10152022-10-07
10033732000052Mack'sPillow Soft Silicone Putty Earplugs52022-10-07
10033732000069Mack'sPillow Soft Silicone Putty Earplugs (Orange)62022-10-07
00033732000079Mack'sPillow Soft Silicone Putty Earplugs72022-10-07
10033732000083Mack'sPillow Soft Silicone Putty Earplugs (Beige)82022-10-07
10033732000106Mack'sKids Size Soft Moldable Silicone Putty Earplugs102022-10-07

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