FDA.reportPublic FDA data

DENALI R & D CORPORATION

Matched from indexed company URL: DENALI CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30063678363006367836DENALI R & D CORPORATION1N2026-01-01134 Old Washington Street Hanover MA US 02339

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
D820ACOREEOW0AuraCore Buildup Material - Core Buildup Material, Dental.+1-781-826-9190denalicorp@denalicorporation.com
D820BONOW0Bonita Pit and Fissure Sealant - Pit and Fissure Sealant, Dental.+1-781-826-9190denalicorp@denalicorporation.com
D820DETCH120Denali Etching Gel - Etching Gel, Dental.+1-781-826-9190denalicorp@denalicorporation.com
D820DETCH30Denali Etching Gel - Etching Gel, Dental.+1-781-826-9190denalicorp@denalicorporation.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
952041154856982K153191Calcium BridgeEBF2016-02-26
952042022258133K152322Resolve 2.0PME2015-12-16
952041373316550K151945Triumph Resin DamEIE2016-02-18
952041472226167K141503DENALI 501CEMENTEMA2014-11-10
952041860485763K132393CERCOM II CEMENTEMA2014-03-14
952041741223358K112597SEITY 37% PHOSPHORIC ACID ETCHANT GELKLE2011-12-07
952042016915574K083473CLEAR BRAVOEBC2009-01-22
952042009306681K083398CERCOM CEMENTEMA2009-01-26
952041954329887K073101AURAVENEER CEMENTEMA2008-01-17
952041692985578K071158AURALAY PIT & FISSURE SEALANTEBC2007-06-05
952041628092366K070702FUSION RESIN CEMENT AND CORE KITEBF2007-05-10
952041964444531K070693AURAVUE PIT & FISSURE SEALANTEBF2007-05-09
952041978719927

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EMA42014-11-10
EBF32016-02-26
EBC22009-01-22
EIE12016-02-18
PME12015-12-16
KLE12011-12-07

NDC#

AVLAYAH

Denali Therapeutics Inc.

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PMN#

Applications#

761485

DENALI THERAPEUTICS INC.

GUDID#