Recall Z-0583-2016— Ultradent Products, Inc.
Class II · Terminated
Class II FDA medical device recall by Ultradent Products, Inc., initiated 2015-12-22, terminated 2016-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 air abrasion.. Reason: 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..
- Recalling firm
- Ultradent Products, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-22
- Terminated
- 2016-10-19
- Firm location
- South Jordan, UT, United States
Product description
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 air abrasion.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.