Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006367836

FEI Number

3006367836

Entity Name

DENALI R & D CORPORATION

City/State/Country

Hanover, MA, US

Establishment Address

134 Old Washington Street, Hanover, MA 02339, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Denali R & D Corporation (Owner Number: 10027456)

Owner / Operator Contact Address

124 Old Washington Street, Hanover, MA 02339, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132393

PMA Number

N/A

All Registered Proprietary Names

AURA Core Super Liner Resolve Triumph Harmony AURA Lay Bonita Aura Opaquer Zenith AURA Veneer AURA Cem

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	2008-11-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-07-29
PME	External Cleaning Solution	Dental	Class 2	872.3260	2015-12-31
EIE	Dam, Rubber	Dental	Class 1	872.6300	2016-07-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2014-12-22
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-11-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-11-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2014-12-22

Official Correspondent

Jan Stannard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Denali R & D 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
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
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02

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.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006367836. Last updated year: 2026. Please use registration number 3006367836 when referencing this establishment in official correspondence.