Pac-Dent, Inc.

FDA Regulatory Profile

Pac-Dent, Inc. appears in FDA public data with 0 recalls, 8 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 12, 2022.

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K202674Medidenta High Speed HandpiecesDecember 12, 2022
K202920OptiCompMay 25, 2022
K202831The iMask Child's Face MaskAugust 26, 2021
K210189Pac-Dent Denture Base ResinJuly 28, 2021
K210412Pac-Dent Ceramic Nanohybrid ResinJuly 26, 2021
K210186PacBond OneJuly 16, 2021
K201182iMask Disposable Surgical Face MaskFebruary 19, 2021
K200330RC-Prime Root Canal Preparation CreamJuly 6, 2020