RecallRadar

FDA Device recall Z-1676-2021

Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment

On 2021-06-02 the FDA classified a Class II recall of Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment by Dentech, citing removing parts for safety reasons due to possible breakage.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1676-2021
ClassificationClass II
Statusterminated
Initiated2021-04-21
Published2021-06-02
Last updated2026-09-13 11:56 UTC
CompanyDentech
DistributionUS

Product

Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.

Reason

Removing parts for safety reasons due to possible breakage.

Identifiers

code_info
Product Code 01012912, no12A Lot Numbers: 190627004, 1812L014, 190708016, 190701018, 190712065, 190712043, 190805016,…Product Code 01012912, no12A Lot Numbers: 190627004, 1812L014, 190708016, 190701018, 190712065, 190712043, 190805016, 190730025, 190731036, 190829013, 190903026, 190815021, 190925016, 191017004, 191009022, 191016040, 191025003, 190816010, 190816060, 191029047, 191016023, 191107029, 191114018, 191121025, 190625014, 191121004, 191029097, 191029138, 191029182, 191030018, 191210088, 200116011, 200204002, 200212011, 191206008, 191206065, 200214043, 200214025, 200225008, 200303006, 200311015, 200402007, 191029223, 191029266, 191029308, 200422023, 200526007, 200526026, 191206068, 191206122, 200130015, 191212035, 200619016, 191206073, 191029351, 200312010, 191206128, 201021075, 190507036, 190508005, 190522012, 190522064, 190524025, 190524061, 190528085, 190530037, 190603009, 190606002, 1806I002, 1808A006, 1810J009, 1812L014. Product Code 01014912, no 12A Lot Numbers: 190813028, 190731042, 190815020, 191113031, 191114017, 191030035, 200121009, 200214042, 200601023, 200619020, 200217009

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1676-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.