SMARTGUARD RX INC

FDA Device Registration & Listing · Layton, UT, US · Registration 3013652641

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013652641
FEI Number
3013652641
Entity Name
SMARTGUARD RX INC
City/State/Country
Layton, UT, US
Establishment Address
201 East 2150 North, Unit E, Layton, UT 84041, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SmartGuard Rx Inc (Owner Number: 10055164)
Owner / Operator Contact Address
201 East 2150 North, Unit E, Layton, UT 84041, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123161
PMA Number
N/A

All Registered Proprietary Names

SmartGuard Elite Night Guard SmartGuard Night Guard SmartGuard Dental Guard SmartGuard Elite

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBR Mouthguard, Over-The-Counter Unknown Class U N/A 2017-06-14
MQC Mouthguard, Prescription Unknown Class U N/A 2017-06-14

Official Correspondent

Brian Larsen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SmartGuard Rx Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013652641. Last updated year: 2026. Please use registration number 3013652641 when referencing this establishment in official correspondence.
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