Data / Medical devices / United States / Denali R & D Corporation

Denali R & D Corporation: FDA-registered device maker in Hanover, MA, United States, 9 510(k) clearances

Name: Denali R & D Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Denali R & D Corporation is registered with the FDA (registration 3006367836) in Hanover, MA, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated February 26, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006367836
Address: 134 Old Washington Street, Hanover, MA, United States, 02339
Owner or operator: Denali R & D Corporation (10027456)
Roles: Complaint file establishment, Specification developer
First device listed: November 10, 2008
Registered through: 2026
Brand names listed: AURA Cem, AURA Core, AURA Lay, AURA Veneer, AURA Vue, Aura Opaquer, Aura Protective Sealer, Bonita and more

Devices it lists

Device	Product code	Class	Role	Source
Cement, Dental	EMA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Dam, Rubber	EIE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
External Cleaning Solution	PME	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 26, 2016	K153191	Calcium Bridge	EBF	Substantially Equivalent	Denali Corporation	accessdata.fda.gov
February 18, 2016	K151945	Triumph Resin Dam	EIE	Substantially Equivalent	Denali Corporation	accessdata.fda.gov
December 16, 2015	K152322	Resolve 2.0	PME	Substantially Equivalent	Denali Corporation	accessdata.fda.gov
November 10, 2014	K141503	DENALI 501CEMENT	EMA	Substantially Equivalent	Denali Corporation	accessdata.fda.gov
March 14, 2014	K132393	CERCOM II CEMENT	EMA	Substantially Equivalent	Denali Corporation	accessdata.fda.gov
January 17, 2008	K073101	AURAVENEER CEMENT	EMA	Substantially Equivalent	Denali Corporation	accessdata.fda.gov
June 5, 2007	K071158	AURALAY PIT & FISSURE SEALANT	EBC	Substantially Equivalent	Denali Corporation	accessdata.fda.gov
May 10, 2007	K070702	FUSION RESIN CEMENT AND CORE KIT	EBF	Substantially Equivalent	Denali Corporation	accessdata.fda.gov
May 9, 2007	K070693	AURAVUE PIT & FISSURE SEALANT	EBF	Substantially Equivalent	Denali Corporation	accessdata.fda.gov

Compare with other makers

Updated February 26, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.