🔍 RecallPedia

Envisiontec US

3 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices

PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

Class I - Dangerous

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

Jan 20, 2022 Other Medical Devices Nationwide View Details →

FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

Class I - Dangerous

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

Jan 6, 2022 Other Medical Devices Nationwide View Details →

FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

Class I - Dangerous

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

Jan 6, 2022 Other Medical Devices Nationwide View Details →