Resin, Denture, Relining, Repairing, Rebasing

TrueDent Clear, TDM 100, Model No. OBJ-09164

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

TrueDent Cyan, TDM 120, Model No. OBJ-09165

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

TrueDent Magenta, TDM130, Model No. OBJ-09166

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

TrueDent Yellow, TDM140, Model No. OBJ-09169

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

TrueDent White, TDM110, Model No. OBJ-09168

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

GRAPHENANO DENTAL G-CAM, Product Codes:

Machining error on cams renders the device unusable.

Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material

The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials

IMPAK Liquid Acrylic Resin sold under the following labels:

Possible presence of foreign material (rust).

IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748.

During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district.

Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic

The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.