EEFClass I

Clamp, Rubber Dam

Dental · 21 CFR 872.6300

MDR events301All time

Recalls1All time

Registered firms96Currently listed

510(k) clearances3All time

Recent MDR events

301 adverse event reports on file

Event type breakdown

Malfunction277

Injury12

Unspecified8

Other4

Most-reported manufacturers

Heraeus Kulzer, Inc.85 Heraeus Kulzer, Inc. Dental Products Div.71 Heraeus Kulzer Llc42 Heraeus Kulzer, Llc41 Coltene Whaledent Inc.14 Heraesus Kulzer, Inc. Dental Products Division8 Coltene/whaledent Inc.4 Heraeus Kulzer, Inc. Dental Products Div4

Recalls

1 recall events for this product code

Dentech Corp.
TerminatedUnknown
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
Removing parts for safety reasons due to possible breakage.
Z-1676-2021 · View FDA record ↗

Registered firms

96 firms currently registered for this product code

510(k) clearances

3 clearances for this product code