Chrysalis Intelligence · Sponsors · Premier Dental Products Company

Premier Dental Products Company

Plymouth Meeting, PA, US · 3 510(k) clearances · 1 recalls

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Total clearances
3
2022-12-06 → 2026-03-03
Last 12 months
2
Product codes
2
Most recent
2026-03-03
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 2025-11-07
KLE Agent, Tooth Bonding, Resin Class II Dental 1 2026-03-03
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2025-02-27
DateSeverityStatusRecall # ProductCodeReason
2025-02-27 Class II Ongoing Z-1408-2025 Premier Solo Diamond - Large Invented Cone; SKU: 807016C. — The hardness not meeting the material specification and may cause the diamond bur to bend.
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2026-03-03 K260682 Bond-PR™ Universal Adhesive KLE Class II Dental
2025-11-07 K253513 MultiMatch Flow Chameleon AntiMicrobial Composite EBF Class II Dental
2022-12-06 K223632 Premier's MultiMatch Universal Chameleon Restorative Composite EBF Class II Dental
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence