DENTCA Crown and Bridge: EU MDD Class IIa registered 2026

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-00856551007407 Basic UDI-DI 00856551007407UDI-DI	Date9 Jun 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00856551007407 UDI-DI	Date29 Oct 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK192806	Date5 Feb 2020Cleared	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-00856551007407 — open Devices and search for it
AccessGUDID record UDI-DI 00856551007407
FDA 510(k) database 510(k) number K192806

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-00856551007407 registered 9 Jun 2026 Active
FDA 510(k) K192806 decided 5 Feb 2020 Active
FDA GUDID UDI-DI 00856551007407 listed 29 Oct 2021 Listed

Timeline

3 dated events

5 Feb 2020 Cleared FDA 510(k) K192806
29 Oct 2021 Listed FDA GUDID 00856551007407
9 Jun 2026 Registered EUDAMED B-00856551007407

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name: Temporary dental crown/bridge resin
Model / reference: DENTCA Crown and Bridge A1 EUDAMED
04301 EUDAMED
DENTCA Crown and Bridge GUDID

Primary DI / UDI-DI: 00856551007407
Basic UDI-DI: B-00856551007407
510(k) Number: K192806
FDA product code: EBG
EMDN code: Q0102050101 Temporary teeth resins
GMDN term: Temporary dental crown/bridge resin

Device class: Class IIa EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 872.3770
EU registration type: Legacy device (under a directive)
EU market of registration: Germany
Advisory committee: Dental
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

Size: Weight — 1 Kilogram

Truth per registry

3 sources · 2 fields differ

Field	EUDAMED	510(k)	GUDID
Model / reference	EUDAMED DENTCA Crown and Bridge A1 04301	510(k) —	GUDID DENTCA Crown and Bridge
Device class	EUDAMED Class IIa	510(k) Class II	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Lucitone Digital Print Denture™ System K243336 17 Dec 2024 FDA record · FDA summary
dima Print Teeth & Temp K233868 23 May 2024 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

This 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)

Similar devices in this category

Other devices filed under TEMPORARY TEETH RESINS.

Other devices from Dentca, Inc.

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DENTCA Denture Teeth for Carbon Printers

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DENTCA Tray Single Arch Attachment(U&L)-S&M

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DENTCA Crown and Bridge

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See all devices from Dentca, Inc. →

Properties

Prescription use
Lot / batch number
Expiration date

Other properties (20, all answered No)