Atlas FDA

PREMISE FLOWABLE

FDA 510(k) clearance K060472 · decided 2006-04-28

Clearance details

K-number
K060472
Device name
PREMISE FLOWABLE
Applicant
Kerr Corporation
Decision
Substantially Equivalent
Date received
2006-02-23
Decision date
2006-04-28
Days to decision
64 days
Clearance type
Traditional
Product code
EBF
Device class
2
Regulation number
872.3690
Medical specialty
Dental
Advisory committee
Dental
Location
Newport Beach, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
PREMISE, PART NO. 32650, 10 PACK UNIDOSE PREMISE A1, dental composite recall (Z-0229-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32651, 10 PACK UNIDOSE PREMISE A2, dental composite recall (Z-0230-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32652, 10 PACK UNIDOSE PREMISE A3, dental composite recall (Z-0231-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental composite recall (Z-0232-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE A4, dental composite recall (Z-0233-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32655, 10 PACK UNIDOSE PREMISE B1, dental composite recall (Z-0234-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32656, 10 PACK UNIDOSE PREMISE B2, dental composite recall (Z-0235-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32657, 10 PACK UNIDOSE PREMISE B3, dental composite recall (Z-0236-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32658, 10 PACK UNIDOSE PREMISE B4, dental composite recall (Z-0237-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32659, 10 PACK UNIDOSE PREMISE C1, dental composite recall (Z-0238-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental composite recall (Z-0239-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE C3, dental composite recall (Z-0240-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32662, 10 PACK UNIDOSE PREMISE C4, dental composite recall (Z-0241-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32663, 10 PACK UNIDOSE PREMISE D2, dental composite recall (Z-0242-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32664, 10 PACK UNIDOSE PREMISE D3, dental composite recall (Z-0243-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32665, 10 PACK UNIDOSE PREMISE D4, dental composite recall (Z-0244-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32666, 10 PACK UNIDOSE PREMISE XL1, dental composite recall (Z-0245-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2, dental composite recall (Z-0246-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32668, 10 PACK UNIDOSE PREMISE A2 OPAQUE, dental composite recall (Z-0247-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32669, 10 PACK UNIDOSE PREMISE A3 OPAQUE, dental composite recall (Z-0248-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental composite recall (Z-0249-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental composite recall (Z-0250-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental composite recall (Z-0251-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite recall (Z-0252-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental composite recall (Z-0253-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite recall (Z-0254-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental composite recall (Z-0255-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite recall (Z-0256-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental composite recall (Z-0257-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite recall (Z-0258-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental composite recall (Z-0259-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL ONLY), dental composi recall (Z-0260-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite recall (Z-0261-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental composite recall (Z-0262-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL ONLY), dental composite recall (Z-0263-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental composite recall (Z-0264-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental composite recall (Z-0265-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental composite recall (Z-0266-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental co recall (Z-0267-2009)Kerr Corp2008-11-25
PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER (INTERNATIONAL ONLY), d recall (Z-0268-2009)Kerr Corp2008-11-25
PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental composite recall (Z-0269-2009)Kerr Corp2008-11-25
PREMISE KIT, PART NO. 33882, UNIDOSE PREMISE MINI KIT, dental composite recall (Z-0270-2009)Kerr Corp2008-11-25