COSMEDENT, INC.

FDA Device Registration & Listing · CHICAGO, IL, US · Registration 1450653

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
1450653
FEI Number
1450653
Entity Name
COSMEDENT, INC.
City/State/Country
CHICAGO, IL, US
Establishment Address
4646 N. RAVENSWOOD AVE., CHICAGO, IL 60640, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
COSMEDENT, INC. (Owner Number: 1450653)
Owner / Operator Contact Address
401 NORTH MICHIGAN AVE., SUITE 2500, Chicago, IL 60611, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K132393
PMA Number
N/A

All Registered Proprietary Names

Renamel Microfill Creative Color Renamel Gingafill Renamel Flowable Microfill Renamel Posterior Occlusal Cosmedent Brushes FlexiStrip CompositeEtch MirrorImage CosmeCore Renamel® NANO™ +plus PorcelEtch Renamel Posterior Body Complete Unfilled Resin Kwik Cosmedent Easywhite RSVP Impression Tray Upper RSVP Impression Tray Lower RSVP Light Body Complete Primer/Unfilled Resin Brush and Sculpt Complete Dual-Cure Catalyst CosmeSeal Desensitizer CosmeTemp Matrix Bands Compule Gun GingaGuard All Ceramic Polishers FlexiPoints MASS SPECTROMETRY MONITORING LINE CONONECTORS Tips Oxygone da Vinci Insure Renamel Microfill Finishing Mandrels Impressiv Enamelize FlexiCups Renamel Flowable Microhybrid Renamel Microhybrid Show-Off RSVP Heavy Body Porcelize

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-03-19
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2008-03-19
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-03-19
KXR Applicator, Resin Dental Class 1 872.3140 2020-01-13
EHM Strip, Polishing Agent Dental Class 1 872.6010 2008-11-05
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2008-05-15
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2018-07-30
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-03-19
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2017-03-29
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-05-15
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-03-19
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2012-11-06
ELW Material, Impression Dental Class 2 872.3660 2008-05-15
MAU Eraser, Dental Stain Dental Class 1 872.6855 2022-07-06
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2020-01-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-03-19
EMA Cement, Dental Dental Class 2 872.3275 2012-11-06
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2010-01-21
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2012-11-06
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-03-19
LBH Varnish, Cavity Dental Class 2 872.3260 2006-03-02
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2008-03-19
ELW Material, Impression Dental Class 2 872.3660 2016-09-22
EMA Cement, Dental Dental Class 2 872.3275 2013-04-12
JEP Retainer, Matrix Dental Class 1 872.4565 2018-12-12
EHE Dispenser, Mercury And/Or Alloy Dental Class 1 872.3080 2020-01-14
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2008-05-15
EHL Point, Abrasive Dental Class 1 872.6010 2008-11-12
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-04-18
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2021-11-08
EMA Cement, Dental Dental Class 2 872.3275 2008-05-15
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2018-07-25
EJQ Wheel, Polishing Agent Dental Class 1 872.6010 2008-11-05
ELW Material, Impression Dental Class 2 872.3660 2008-04-24
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2008-03-19
EHK Cup, Prophylaxis Dental Class 1 872.6290 2008-11-05
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2022-11-30
EMA Cement, Dental Dental Class 2 872.3275 2008-03-19
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2008-03-19
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2008-11-13
EMA Cement, Dental Dental Class 2 872.3275 2019-11-13

Official Correspondent

MICHAEL O'MALLEY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COSMEDENT, INC.
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
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01
K153476 Kuraray Noritake Dental, Inc. KATANA AVENCIA Block 2016-08-23
K093019 Enamelite, LLC ENAMELITE ACRYSEAL SPRAY SEALANT 2009-12-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1450653. Last updated year: 2026. Please use registration number 1450653 when referencing this establishment in official correspondence.
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