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Devices
PREMISE
Model / Serial
LOT NUMBER(S): 2999220, 3001301, 3001302, 3018174, and 3031244.
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
Product Description
PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE C3, dental composite
Manufacturer
Kerr Corp
1 Event
Recall of PREMISE
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Manufacturer
Kerr Corp
Manufacturer Address
Kerr Corp, 1717 W Collins Ave, Orange CA 92867-5422
Source
USFDA
40 devices with a similar name
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PREMISE
Model / Serial
LOT NUMBER(S): 3001345, and 3001346
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
Product Description
PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite
Manufacturer
Kerr Corp
PREMISE
Model / Serial
LOT NUMBER(S): 3015352, and 3001330
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
Product Description
PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental composite
Manufacturer
Kerr Corp
PREMISE
Model / Serial
LOT NUMBER: 3001332
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
Product Description
PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite
Manufacturer
Kerr Corp
PREMISE
Model / Serial
LOT NUMBER(S): 3001314, and 3027204
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
Product Description
PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2, dental composite
Manufacturer
Kerr Corp
PREMISE
Model / Serial
LOT NUMBER(S): 2981424, 3001270, 3001273, 3027780, and 3031654.
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
Product Description
PREMISE, PART NO. 32650, 10 PACK UNIDOSE PREMISE A1, dental composite
Manufacturer
Kerr Corp
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