Manufacturer registered with FDA

Denali R & D Corporation

Hanover, MA, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10027456Specification developer

Device types listed: 5
Brands and models: 14
510(k) clearances: 22009–2009
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2000–2026

Devices listed with FDA

What Denali R & D Corporation currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	AURA CoreAura Protective SealerAURA VueClear VueSuper Liner	2008
Dental CementEMA · Class 2	Dental cements	Maker	AURA CemAura OpaquerAURA VeneerHarmonyZenith	2008
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Maker	AURA LayBonita	2008
Rubber DamEIE · Class 1	Rubber dam systems	Maker	Triumph	2016
External Cleaning SolutionPME · Class 2	—	Maker	Resolve	2015

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Denali R & D Corporation as the applicant.

Decided	510(k)	Device	Device type
26 Jan 2009	K083398	CERCOM CEMENT	EMA Dental Cement
22 Jan 2009	K083473	CLEAR BRAVO	EBC Pit and Fissure Sealant and Conditioner

Also lists devices cleared under other names

Denali R & D Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Denali Corporation (9).

Decided	510(k)	Device	Applicant	Device type
26 Feb 2016	K153191	Calcium Bridge	Denali Corporation	EBF Resin Tooth Shade Material
18 Feb 2016	K151945	Triumph Resin Dam	Denali Corporation	EIE Rubber Dam
16 Dec 2015	K152322	Resolve 2.0	Denali Corporation	PME External Cleaning Solution
10 Nov 2014	K141503	DENALI 501CEMENT	Denali Corporation	EMA Dental Cement
14 Mar 2014	K132393	CERCOM II CEMENT	Denali Corporation	EMA Dental Cement
17 Jan 2008	K073101	AURAVENEER CEMENT	Denali Corporation	EMA Dental Cement
5 Jun 2007	K071158	AURALAY PIT & FISSURE SEALANT	Denali Corporation	EBC Pit and Fissure Sealant and Conditioner
10 May 2007	K070702	FUSION RESIN CEMENT AND CORE KIT	Denali Corporation	EBF Resin Tooth Shade Material
9 May 2007	K070693	AURAVUE PIT & FISSURE SEALANT	Denali Corporation	EBF Resin Tooth Shade Material

Registered establishments

Establishment	Location	What it does
DENALI R & D CORPORATIONFDA reg. 3006367836	Hanover, MA, United States	Complaint file establishment, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10027456). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.