FDA.reportPublic FDA data

ASEPTICO, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30176043017604ASEPTICO, INC.1Y2026-01-018333 216th St SE WOODINVILLE WA US 98072
30111976243011197624Aseptico1N2020-04-258333 216th Street SE Woodinville, WA 98072 Woodinville WA US 98072

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
10817417020166Dentsply Sirona - CORDLESS OBTURATION SYSTEM, GUTTA SMART425-487-3157Regulatory@aseptico.com
10817417020227Aseptico - ENDODONTIC SYSTEM AEU-27DTCR425-487-3157Regulatory@aseptico.com
10817417020326Aseptico - ENDODONTIC SYSTEM AEU-27DTCR W/ ON/OFF WIRELESS FOOTSWITCH425-487-3157Regulatory@aseptico.com
10817417020371Aseptico - DENTAL IMPLANT MOTOR SYSTEM 70 NCM W/AE-7PMW425-487-3157Regulatory@aseptico.com
10817417020388Aseptico - Dental Implant Motor System425-487-3157Regulatory@aseptico.com
10817417021323Aseptico - TUBING SET DISPOSABLE 10 FT AEU-1000/1070 (PKG 10)4254873157regulatory@aseptico.com
10817417021330Aseptico - TUBING SET DISPOSABLE 10 FT AEU-1000/1070 (Single)4254873157regulatory@aseptico.com
10817417021347Treace Percuplasty - INSTRUMENT TRAY TREACE PERCUPLASTY MIS POWER SYSTEM4254873157regulatory@aseptico.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
85541248296292K905401ASEPTIMINI UNIT, ADU-10EIA1991-02-20
85541940918194K884828HANDIDAMEIE1989-02-03
85541633701824K201292TRAUS SIP20EBW2021-02-11
85541073586151K150129AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)EKX2015-05-28
85541374225001K142124AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEMEKX2014-12-31
85541742425202K130693AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEMELC2013-08-14
85541949415199K123695TRAUS SIP10EKY2012-12-18
85541229672131K111078AEU-26L ELCTRONIC ENDODONTIC SYSTEMEKX2011-06-14
85541076578948K103399GENERAL DENISTRY MOTOREKX2011-02-28
85541053671329K101332AMC-20 PORTABLE DENTAL CART MODEL AMC-20EIA2011-04-11
85541841981051K051872MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011EFB2005-10-03
85541141047052K051077E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101EGS2005-05-03
85541769379659K050201AEU-14CF EXPENDITIONEIA2005-03-18
85541206985180K030163ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925EKX2003-03-03
85541357921374K022217AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEMEIA2002-10-24
85541756821587K020137AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTONEGS2002-03-04
1732781488000216
1732781935372467
85541077142045
85541084037947
85541221673503
85541332245245
85541469841707
85541514616756
85541581878667
85541668427738
85541780180637
85541817204873
85541833435630
85541876164172
85541917003282
85541950751405
85542004894031
85542030710682

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EKX52015-05-28
EIA42011-04-11
EGS22005-05-03
EBW12021-02-11
ELC12013-08-14
EKY12012-12-18
EFB12005-10-03
EIE11989-02-03

PMN#

GUDID#

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