510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Aseptico, Inc.

Woodinville, WA, US

ASEPTICO, INC. appears in FDA device records in Woodinville, WA. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Aseptico, Inc. between 1988 and 2015. The busiest year on record is 2011, with 3. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Aseptico, Inc., by decision year
YearClearances
19881
19891
19911
19921
19931
20022
20032
20052
20071
20113
20131
20141
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K150129AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)EKXSubstantially Equivalent
K142124AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEMEKXSubstantially Equivalent
K130693AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEMELCSubstantially Equivalent
K111078AEU-26L ELCTRONIC ENDODONTIC SYSTEMEKXSubstantially Equivalent
K101332AMC-20 PORTABLE DENTAL CART MODEL AMC-20EIASubstantially Equivalent
K103399GENERAL DENISTRY MOTOREKXSubstantially Equivalent
K070866ASC-12 PIEZOELECTRIC SCALERELCSubstantially Equivalent
K051077E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101EGSSubstantially Equivalent
K050201AEU-14CF EXPENDITIONEIASubstantially Equivalent
K030895ASEPTICO ENDOPEX V, MODEL AEU-40LQYSubstantially Equivalent
K030163ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925EKXSubstantially Equivalent
K022217AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEMEIASubstantially Equivalent
K020137AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTONEGSSubstantially Equivalent
K923157DENTAL RUBBER DAMEIESubstantially Equivalent
K923163RUBBER DAM CLAMPEIESubstantially Equivalent
K905401ASEPTIMINI UNIT, ADU-10EIASubstantially Equivalent
K884828HANDIDAMEIESubstantially Equivalent
K882526DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.EIASubstantially Equivalent

Registered establishments

FDA registered establishments for Aseptico, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30176043017604ASEPTICO, INC.8333 216th St SE, WOODINVILLE, WA 98072 US2026and 11 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain