Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006694515

FEI Number

3006694515

Entity Name

indigodental GmbH

City/State/Country

Pinneberg Schleswig-Holstein, DE

Establishment Address

Fahltskamp 5, Pinneberg Schleswig-Holstein 25421, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

indigodental GmbH (Owner Number: 10023218)

Owner / Operator Contact Address

Fahltskamp 5, Pinneberg, DE-SH 25421, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080480

PMA Number

N/A

All Registered Proprietary Names

QuikGlaze QuikGlaze XL QuikGlaze Temp White

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	2007-11-12
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2015-05-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-12
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-02-04
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-11-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-08-17
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-02-22
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2018-06-05
ELW	Material, Impression	Dental	Class 2	872.3660	2008-07-02
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-10-26
MVL	Cord, Retraction	Unknown	Class U	N/A	2019-09-16
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-11-28
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2010-08-17
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2008-08-07
KXR	Applicator, Resin	Dental	Class 1	872.3140	2015-05-20
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2008-11-28
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2010-06-22
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2012-03-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-03-08

Official Correspondent

No official correspondent registered.

US Agent Details

Pamela Papineau Business: Delphi Medical Device Consulting, Inc. Email: delphimdc@comcast.net Phone: (978) 7588322

Related Public Records

Same Entity

indigodental GmbH

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
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08

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.

Similar Registrations

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3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI
3032163716	Solventum US LLC	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006694515. Last updated year: 2026. Please use registration number 3006694515 when referencing this establishment in official correspondence.