FDADecember 22, 2015device

InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as ai...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.

What to do

FDA enforcement status: Terminated

Brands named

ultradent productsultradent

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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