RANDMARK DENTAL PRODUCTS, LLC

FDA Device Registration & Listing · Lusby, MD, US · Registration 3009133124

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
3009133124
FEI Number
3009133124
Entity Name
RANDMARK DENTAL PRODUCTS, LLC
City/State/Country
Lusby, MD, US
Establishment Address
284 Elkins Ln, Lusby, MD 20657, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Randmark Dental Products, LLC (Owner Number: 10037706)
Owner / Operator Contact Address
284 Elkins Ln, Lusby, MD 20657, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K110468
PMA Number
N/A

All Registered Proprietary Names

NiteBite¿

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQC Mouthguard, Prescription Unknown Class U N/A 2011-08-09
OBR Mouthguard, Over-The-Counter Unknown Class U N/A 2011-08-09

Official Correspondent

Randy Widen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Randmark Dental Products, LLC
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 3009133124. Last updated year: 2026. Please use registration number 3009133124 when referencing this establishment in official correspondence.
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