Chrysalis Intelligence · Sponsors · Pac-Dent, Inc.

Pac-Dent, Inc.

Brea, CA, US · 8 510(k) clearances

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Total clearances
8
2020-07-06 → 2022-12-12
Last 12 months
0
Product codes
7
Most recent
2022-12-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EBF Material, Tooth Shade, Resin Class II Dental 2 2022-05-25
EFB — — — 1 2022-12-12
OXZ Pediatric/Child Facemask Class II General, Plastic Surgery 1 2021-08-26
EBI — — — 1 2021-07-28
KLE Agent, Tooth Bonding, Resin Class II Dental 1 2021-07-16
FXX — — — 1 2021-02-19
KJJ Cleanser, Root Canal Unclassified Unknown 1 2020-07-06
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2022-12-12 K202674 Medidenta High Speed Handpieces EFB — —
2022-05-25 K202920 OptiComp EBF Class II Dental
2021-08-26 K202831 The iMask Child's Face Mask OXZ Class II General, Plastic Surgery
2021-07-28 K210189 Pac-Dent Denture Base Resin EBI — —
2021-07-26 K210412 Pac-Dent Ceramic Nanohybrid Resin EBF Class II Dental
2021-07-16 K210186 PacBond One KLE Class II Dental
2021-02-19 K201182 iMask Disposable Surgical Face Mask FXX — —
2020-07-06 K200330 RC-Prime Root Canal Preparation Cream KJJ Unclassified Unknown
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence