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DentaBASE

ASIGA PTY LTD · Model 03569 · UDI-DI 09359215000369

EBI Prescription

510(k) clearances

179

Adverse events

Recalls

173

Facilities

Description

Asiga DentaBASE resins are used with digital light processing (DLP) based 3D printers to produce denture bases. DentaBASE resin has been validated for use with the Asiga Max Series and Pro Series printers. Asiga DentaBASE is a Type 4 light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. Asiga DentaBASE resin material is used in a DLP 3D printer, which prints the denture base from CAD data. The denture base is built by solidifying successive layers of photopolymer against eachother. Each layer is light cured before adding the next layer, with post-curing in a light chamber unit. The 3D printer and light-curing unit are not included with the device. The device is supplied as a pre-mixed resin in one color, natural pink. The device is supplied non-sterile, and it is not intended to be sterilised.

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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Data 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.