OTC DENTAL

FDA Device Registration & Listing · N Las Vegas, NV, US · Registration 3013425656

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
3013425656
FEI Number
3013425656
Entity Name
OTC DENTAL
City/State/Country
N Las Vegas, NV, US
Establishment Address
3825 W Cheyenne Ave Ste 606, N Las Vegas, NV 89032, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
OTC Dental (Owner Number: 10053689)
Owner / Operator Contact Address
3825 W Cheyenne Ave, Ste 606, North Las Vegas, NV 89032, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K974865
PMA Number
N/A

All Registered Proprietary Names

DenSureFit DenSureFitPro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2026-01-15

Official Correspondent

Steven Delepine

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OTC Dental
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19

Similar Registrations

Registration Number Establishment Name Location
3017374693 STRATASYS LTD - Headquarter Rehovot Central, IL
2950685 CO-ORAL-ITE DENTAL MFG. CO. DIAMOND SPRINGS, CA, US
3032727 TALON ACRYLICS, INC. Winchester, OR, US
3008320092 Shandong Huge Dental Material Corporation Rizhao Shandong, CN
1410097 GC AMERICA INC. ALSIP, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013425656. Last updated year: 2026. Please use registration number 3013425656 when referencing this establishment in official correspondence.
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