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
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00860013500733Custom Night GuardGrindGuard Inc.OBR2026-03-05
00860013500740Custom Night GuardGrindGuard Inc.OBR2026-03-05
00860014754609Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860014754616Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860014754623Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860015217721enCore Night GuardENCORE LABORATORY LLCOBR2026-03-02
00860015217738enCore Night GuardENCORE LABORATORY LLCOBR2026-03-02
00860015217707enCore Night GuardENCORE LABORATORY LLCOBR2026-01-08
00692121032055SleepRightSplintek Inc.OBR2025-12-17
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00860013500702Custom Night GuardGrindGuard Inc.OBR2025-03-17
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00195515045247Amazon BasicsAMAZON.COM SERVICES LLCOBR2025-01-25
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00651080651523PlackersRANIR, LLCOBR2024-04-26
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00311917046877WalgreensWALGREEN CO.OBR2024-01-18
10311917046874WalgreensWALGREEN CO.OBR2024-01-18
00692121035216SleepRightSplintek Inc.OBR2023-08-30
00866618000036GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00866618000043GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18