OraLabs, Inc.

FDA Device Registration & Listing · Parker, CO, US · Registration 3001237145

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
3001237145
FEI Number
3001237145
Entity Name
OraLabs, Inc.
City/State/Country
Parker, CO, US
Establishment Address
18685 E Plaza Dr, Parker, CO 80134, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
OraLabs, Inc. (Owner Number: 10041724)
Owner / Operator Contact Address
18685 East Plaza Drive, Parker, CO 80134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181839
PMA Number
N/A

All Registered Proprietary Names

Oral B Night Time Dental Guard Dry Mouth Spray

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 2012-08-23
LFD Saliva, Artificial Unknown Class U N/A 2020-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OraLabs, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001237145. Last updated year: 2026. Please use registration number 3001237145 when referencing this establishment in official correspondence.
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