openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI-DI 7290018915004 Lots 22994 (exp. 02-Apr-2024) and 23425 (exp. 07-Nov-2024)
Distribution pattern
US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.
device · product 2 of 5
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI-DI 7290018915400 Lots 23485 (exp. 08-Nov-2024) and 22904 (exp. 09-Feb-2024)
Distribution pattern
US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.
device · product 3 of 5
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI-DI 7290018915608 Lot 23123 (exp. 01-May-2024)
Distribution pattern
US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.
device · product 4 of 5
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI-DI 7290018915806 Lot 22861 (exp. 01-Feb-2024)
Distribution pattern
US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.
device · product 5 of 5
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
UDI-DI 7290018915202 Lot 22377 (exp. 12-Oct-2023)
Distribution pattern
US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.
