Home › Sprintray, Inc. › Ceramic Crown - Bleach - Single-unit Capsule 1-Pack
Ceramic Crown - Bleach - Single-unit Capsule 1-Pack
Sprintray, Inc. · Model SRI-0204050 · UDI-DI 00850039704772
1
510(k) clearances
178
Adverse events
16
Recalls
172
Facilities
Description
SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer upon layer of the composite material.
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.