Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1483306

FEI Number

1483306

Entity Name

ASTRON DENTAL CORPORATION

City/State/Country

Lake Zurich, IL, US

Establishment Address

815 Oakwood Rd Ste G, Lake Zurich, IL 60047, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Astron Dental Corporation (Owner Number: 1483306)

Owner / Operator Contact Address

815 Oakwood Rd Unit G, --, Lake Zurich, IL 60047, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111828

PMA Number

N/A

All Registered Proprietary Names

Duraclean II Denture Cleaner Duraclean Denture Cleaner Astron LC Light Cure Base Plate Astron LC Light Cure Reline Astron LC Light Cure Custom Tray Clearsplint ES Clearsplint Ultraflex Clearsplint Disc Labtec Pro Labtec Reline

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2008-03-19
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2008-04-21
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2016-08-12

Official Correspondent

Beth Abbinanti

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Astron Dental Corporation

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1483306. Last updated year: 2026. Please use registration number 1483306 when referencing this establishment in official correspondence.