{ "format": "devicerts.device.v1", "cite_as": "DENTCA Crown and Bridge, Dentca, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/dentca-crown-and-bridge-ebg (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/dentca-crown-and-bridge-ebg", "json_url": "https://devicerts.com/devices/dentca-crown-and-bridge-ebg.json", "markdown_url": "https://devicerts.com/devices/dentca-crown-and-bridge-ebg.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA 510(k)", "url": "https://open.fda.gov/apis/device/510k/" }, { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" } ], "registry_records_last_synced": "2026-10-22", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.", "attribution": "DevicErts, https://devicerts.com/devices/dentca-crown-and-bridge-ebg", "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails." }, "device": { "name": "DENTCA Crown and Bridge", "registry_name": "DENTCA Crown and Bridge", "url": "https://devicerts.com/devices/dentca-crown-and-bridge-ebg", "manufacturer": { "name": "Dentca, Inc.", "url": "https://devicerts.com/manufacturers/dentca-inc", "country": "United States", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class IIa", "system": "EU MDD" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00856551007407", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00856551007407", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K192806", "registries": [ "FDA 510(k)" ] } ] } ], "product_codes": [ "EBG" ], "emdn": [ { "code": "Q0102050101", "term": "TEMPORARY TEETH RESINS" } ], "gmdn": [ { "code": "45236", "term": "Temporary dental crown/bridge resin" } ], "description": { "text": "The DENTCA Crown and Bridge Resin is a photocurable polymer material designed for additive manufacturing of dental crowns and bridges. It is classified as a dental resin for temporary or provisional restorations, intended to replicate the structural properties of conventional acrylic while enabling digital fabrication.\n\nThis resin is supplied as a liquid for use in 3D printing systems, specifically compatible with Carbon printers, to create temporary dental restorations. Fabricated crowns and bridges are intended for short-term use (up to 30 days) and are not intended for permanent placement. The device holds FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD)", "ai_generated": true, "generated_on": "2026-09-18", "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record." }, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDD", "number": "B-00856551007407", "number_label": "Basic UDI-DI", "device_udi_di": "00856551007407", "date": "2026-06-09", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "00856551007407", "number_label": "UDI-DI", "device_udi_di": null, "date": "2021-10-29", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K192806", "number_label": null, "device_udi_di": null, "date": "2020-02-05", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false } ], "no_longer_listed_by": [], "certificates": [], "recalls": [], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Generic name", "values": [ { "value": "Temporary dental crown/bridge resin", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / reference", "values": [ { "value": "DENTCA Crown and Bridge A1", "registries": [ "EUDAMED" ] }, { "value": "04301", "registries": [ "EUDAMED" ] }, { "value": "DENTCA Crown and Bridge", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00856551007407", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-00856551007407", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K192806", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "EBG", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Q0102050101", "registries": [ "EUDAMED" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Temporary dental crown/bridge resin", "code": "45236", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class IIa", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation", "values": [ { "value": "21 CFR Part 872.3770", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Germany", "registries": [ "EUDAMED" ] } ] }, { "label": "Advisory committee", "values": [ { "value": "Dental", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA decision", "values": [ { "value": "SESE", "registries": [ "FDA 510(k)" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Dimensions & Sizes", "fields": [ { "label": "Size", "values": [ { "value": "Weight — 1 Kilogram", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Prescription use", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Reusable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Reprocessed single-use device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a substance derived from human blood or plasma", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains human tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Administering medicine", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Measuring function", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a medicinal substance", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }