MVLUnclassified

Cord, Retraction

Unknown

MDR events25All time

Recalls1All time

Registered firms78Currently listed

510(k) clearances36All time

Recent MDR events

25 adverse event reports on file

Event type breakdown

Injury18

Unspecified4

Malfunction2

Other1

Most-reported manufacturers

3m Deutschland Gmbh8 Produits Dentaires Pierre Rolland6 Dentsply Caulk2 Premier Dental Products Company2 Unspecified1 Dentsply Llc1 Parkell1 Pascal Co., Inc.1

Recalls

1 recall events for this product code

Inter-Med Llc
Open, ClassifiedJun 10, 2026
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit,
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.
Z-2400-2026 · View FDA record ↗

Registered firms

78 firms currently registered for this product code

510(k) clearances

36 clearances for this product code