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3Shape Abutment Designer Software

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K151455Ref E2Ref R1.1Ref E4Ref E3Ref 88.2

by 3shape A/S

Identity

Trade Name
3shape EUDAMED
Dental System FDA UDI
Lab Scanner FDA UDI
Anatomy Design FDA UDI
Generic Name
CAD/CAM software FDA UDI
Dental milling system, CAD/CAM, laboratory FDA UDI
Device Name
E Series EUDAMED
Anatomy Design EUDAMED
Dental System EUDAMED
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion. FDA UDI
Digital impression lab scanner for CAD/CAM FDA UDI
Dental CAD Software FDA UDI
Model / Reference
E2 EUDAMEDFDA UDI
E3 EUDAMEDFDA UDI
R1.1 EUDAMEDFDA UDI
E4 EUDAMEDFDA UDI
88.2 EUDAMED
88.2.x FDA UDI
Description
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion. FDA UDI
Digital impression lab scanner for CAD/CAM FDA UDI
Dental CAD Software FDA UDI

Identifiers

Primary DI / UDI-DI
05902729753630 EUDAMEDFDA UDI
05902729750363 EUDAMEDFDA UDI
05902729750370 EUDAMEDFDA UDI
05902729752220 EUDAMEDFDA UDI
05902729752916 EUDAMEDFDA UDI
Basic UDI-DI
590272975007F4 EUDAMED
590272975006F2 EUDAMED
590272975003EU EUDAMED
510(k) Number
K151455 FDA 510(k)
FDA Product Code
PNP FDA 510(k)
NOF FDA UDI
EMDN Code
Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Z12119082 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
GMDN Term
CAD/CAM software FDA UDI
Dental milling system, CAD/CAM, laboratory FDA UDI

Classification

Device Class
Class I EUDAMED
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
872.3661 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
Denmark EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDIFDA UDI

Serial Number

No

FDA UDIFDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The 3Shape Abutment Designer Software is a Dental Abutment Design Software for Dental Laboratory, classified as a Class II medical device. It is a digital tool designed to assist dental professionals in creating patient-specific dental implant abutments by leveraging computer-aided design (CAD) technology. The software enables precise virtual planning and fabrication of abutments tailored to individual anatomical requirements, improving fit and functionality in restorative dentistry.

This software is supplied as a digital download or installation package, intended for use in dental laboratories and clinics. It operates on compatible computer systems and integrates with digital impression scanners and CAD/CAM workflows. The device is not single-use or reusable in the traditional sense, as it is a software application requiring periodic updates. Authorized under FDA 510(k) clearance and MDR compliance, it adheres to regulatory standards for dental software, ensuring clinical accuracy and safety in abutment design.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 3Shape Software - Explore it all, 3Shape Dental System — Dental CAD software for labs, 3Shape Dental System - Kulzer, PDF Abutment Design, 3shape Abutment Designer Software 510 (k) FDA Premarket Notification ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
3shape A/S

Sources (11)

  • FDA 510(k) K151455 24 fields · synced Sep 18, 2026
  • FDA UDI ca0b9101-d497-482f-9d16-5aeb4ee6e406 34 fields · synced May 22, 2026
  • FDA UDI 4bd4596e-bfba-46e5-893c-c6db29921e96 35 fields · synced May 25, 2026
  • FDA UDI 0e56f04c-d217-431a-b33e-41e1c37170c4 35 fields · synced May 30, 2026
  • FDA UDI 54ce543d-b970-4285-b174-b90dfe572b07 34 fields · synced May 30, 2026
  • FDA UDI 3aeedb04-a609-40e6-a13d-245bc1edac01 35 fields · synced May 30, 2026
  • EUDAMED 5f67ef9e-17fd-41c0-a72d-a92e215d007c 61 fields · synced Jul 11, 2026
  • EUDAMED 7340df3a-fd55-42be-aabd-9f4f511e85c2 61 fields · synced Jul 12, 2026
  • EUDAMED c713acc5-a972-4ab5-b020-3b55c09137a1 61 fields · synced Jul 13, 2026
  • EUDAMED cec76617-5c25-4142-9955-5f5509ef865b 61 fields · synced Jul 23, 2026
  • EUDAMED 0ecc1879-d99c-4894-9c16-23c4da3b73c5 61 fields · synced Jul 28, 2026