Abutment Design— 510(k) K200100

Substantially Equivalent

3Shape A/S

FDA 510(k) clearance K200100 for Abutment Design, Substantially Equivalent on 2020-10-07. Applicant: 3Shape A/S. Device class: 2.

Clearance details

Applicant: 3Shape A/S
Product code: Code PNP
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2020-01-16
Decision date: 2020-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNP

K233252 — Straumann CARES Visual and Nova Dental CAD2024-12-26
K231529 — CloudPoint FastDesign Chairside2024-03-14
K221107 — TRUST2023-07-18
K193352 — AbutmentCAD2021-07-21
K200191 — Sirona Dental CAD/CAM System with InLab Software2020-08-19

More clearances from 3Shape A/S

K191911 — 3Shape Splint Design2019-11-27
K180941 — Ortho System2018-10-17
K171634 — Ortho System2018-01-17
K163677 — Ortho System2017-04-20
K161884 — Ortho System2017-04-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.