EHYClass I

Tray, Impression, Preformed

Dental · 21 CFR 872.6880

MDR events0All time

Recalls3All time

Registered firms329Currently listed

510(k) clearances16All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

3 recall events for this product code

Rite-Dent Manufacturing Corp.
TerminatedNov 5, 2005
Product names:
At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on the ingredients list.
Z-0128-06 · View FDA record ↗
Harry J Bosworth Company
TerminatedJan 25, 2005
Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Bosworth Company, 7227 North Hamlin Avenue, Sk
The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.
Z-0420-05 · View FDA record ↗
Implant Direct Sybron Manufacturing, LLC
TerminatedUnknown
6534-08N InterActive Implant Open-Tray Transfer Narrow
The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression. This discrepancy may lead to the possibility of an oversized crown fabrication.
Z-2046-2016 · View FDA record ↗

Registered firms

329 firms currently registered for this product code

510(k) clearances

16 clearances for this product code