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Unitek Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K944286METAL-LINED TRANSCEND CERAMIC BRACKETNovember 29, 1994
K933501ALASTIKApril 28, 1994
K940165ALASTIKMarch 7, 1994
K923999ALASTIK NSJune 24, 1993
K924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSNovember 25, 1992
K924295DEBRACKETING INSTRUMENTNovember 23, 1992
K923432GERMAN MINI DYNALOCKOctober 30, 1992
K911271ADHESIVE PRECOATED BRACKETSMay 29, 1991
K910288NONSTAINING ALASTIKSMarch 29, 1991
K890529ALASTIGARDMarch 9, 1989
K880392ORTHOLUX VISIBLE LIGHT CURING UNITApril 7, 1988
K880393TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVEMarch 31, 1988
K861965UNITEK CERAMIC BRACKET SYSTEMJune 9, 1986
K851386UNITEK DISPOSABLE IMPRESSION SYRINGEApril 29, 1985
K843742UNITEK CONVERTIBLE CAP REMOVER TOOLNovember 9, 1984
K832654HEATED GUTTA PERCHA DELIVERY SYSTEMSeptember 26, 1983
K832253X-704August 31, 1983
K831098DOMINIONJune 16, 1983
K831096STROMA IIJune 15, 1983
K831097CONCERTOJune 15, 1983