FDA.reportPublic FDA data

SmartGuard

Primary DI
00866330000208
Brand
SmartGuard
Company
Smartguard Rx, Inc.
Model
SGDG6
Device description
Dental mouth guard for clenching and grinding teeth (bruxism)
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123161000SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITESmartguard, Inc.2013-03-14MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10866330000205PackageGS13In Commercial Distribution
20866330000202PackageGS14In Commercial Distribution
30866330000209PackageGS112In Commercial Distribution
00866330000208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086633000020510866330000205
2086633000020220866330000202
3086633000020930866330000209
00866330000208008663300002088663300002080866330000208

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
1-855-576-2785brian@smartguardrx.com

Regulatory Flags#

DUNS number
079556398
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866330000260SmartGuardSGASD2021-11-05
10866330000205SmartGuardSGDG62020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967026112RodinPac-Dent, Inc.MQC2026-05-20
00190730084583Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
00190730084590Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
00087701190667Good Neighbor PharmacyAmerisourcebergen Drug CorporationOBR2025-03-03
00195515045247Amazon BasicsAMAZON.COM SERVICES LLCOBR2025-01-25
H66842000141KeyPrintKeystone IndustriesMQC2024-09-26
00651080651523PlackersRANIR, LLCOBR2024-04-26
00050428270691CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOBR2024-04-16
00311917046877WalgreensWALGREEN CO.OBR2024-01-18
H66841101411KeyPrintKeystone IndustriesMQC2023-09-25
H66842201511KeyPrintKeystone IndustriesMQC2023-09-25
EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
D745701164RSN00070Glidewell TuffSplint™ Appliance ResinPrismatik Dentalcraft, IncMQC2023-04-11
00810002220241The Luco Hybrid OSA ApplianceJOHN'S DENTAL LABORATORY INCMQC2023-03-28
H66842000111KeyPrintKeystone IndustriesMQC2023-02-20
H66842001611KeyPrintKeystone IndustriesMQC2023-02-20
H66842200111KeyPrintKeystone IndustriesMQC2023-02-20
H66842201141HeyGearsKeystone IndustriesMQC2023-02-20
H66842201611KeyPrintKeystone IndustriesMQC2023-02-20
H66850524011Nexa3DKeystone IndustriesMQC2023-02-20
H66852233011Nexa3DKeystone IndustriesMQC2023-02-20
H668D6400231PearsonKeystone IndustriesMQC2023-02-20
H668D6400241PearsonKeystone IndustriesMQC2023-02-20
H668D6400271PearsonKeystone IndustriesMQC2023-02-20
H668210041American DentalKeystone IndustriesMQC2022-11-30
H668210051American DentalKeystone IndustriesMQC2022-11-30
H668210061American DentalKeystone IndustriesMQC2022-11-30
H66870001901ProformKeystone IndustriesMQC2022-11-30
H6687000190R11ProformKeystone IndustriesMQC2022-11-30