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Acrylic Block
SUN MEDICAL CO.,LTD. · Model MCL-010-M · UDI-DI 14560227799093
10
510(k) clearances
178
Adverse events
16
Recalls
172
Facilities
Description
Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Light Pink.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-19 | STRATASYS LTD | 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 exp |
| 2024-01-19 | STRATASYS LTD | 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 exp |
| 2024-01-19 | STRATASYS LTD | 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 exp |
| 2024-01-19 | STRATASYS LTD | 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 exp |
| 2024-01-19 | STRATASYS LTD | 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 exp |
| 2023-10-24 | GRAPHENANO DENTAL SL | Machining error on cams renders the device unusable. |
| 2023-04-10 | Keystone Industries | 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 |
| 2022-01-06 | Envisiontec US Llc | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin |
| 2022-01-06 | Envisiontec US Llc | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin |
| 2018-09-12 | CMP Industries, Llc | Foreign material in product |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.