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

Chicago, IL, US

Austenal Dental, Inc. appears in FDA device records in Chicago, IL. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
19
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 19 510(k) clearances for Austenal Dental, Inc. between 1985 and 1989. The busiest year on record is 1986, with 8. The most recent is 1989, with 1.

Clearances by year, as a table
510(k) clearance decisions for Austenal Dental, Inc., by decision year
YearClearances
19852
19868
19876
19882
19891
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K890713OVERDENTURE - STUD ATTACHMENTDZESubstantially Equivalent
K883799BASE, DENTURE, RELINING, REPAIRING, REBASING,RESINEBISubstantially Equivalent
K880875VITALLIUM EQUIPOISE ALLOYEJHSubstantially Equivalent
K871849LIGHT CURE DENTURE GLAZEEBISubstantially Equivalent
K872746VITALLIUM WIREEJWSubstantially Equivalent
K863630AUSTENAL ACUPAC 20 DENTURE BASE MATERIALEBISubstantially Equivalent
K865025AUSTENAL CONDENSING INSTRUMENTEKGSubstantially Equivalent
K862557AUSTENAL ACUSOFT SOFT LINEREBISubstantially Equivalent
K864826A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)EJHSubstantially Equivalent
K862856PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOREJSSubstantially Equivalent
K862667COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOYEJHSubstantially Equivalent
K862558AUSTENAL ACUPAC HI DENTURE BASE MATERIALEBISubstantially Equivalent
K862417NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOYEJHSubstantially Equivalent
K860964WHITE SILVER SOLDER AND YELLOW SILVER SOLDEREJSSubstantially Equivalent
K860911AUSTENAL HYCO ALGINATE IMPRESSION MATERIALELWSubstantially Equivalent
K860217NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)EJHSubstantially Equivalent
K854957AUSTENAL DENTAL COMPOSITE RESINEBDSubstantially Equivalent
K853160AUSTENAL MODIFIED ACRYLIC DENTURE RESINELMSubstantially Equivalent
K844497AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOYEJHSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

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

Verification record

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