Planmed Verity

FDA 510(k) K143435 · Planmed OY

Substantially Equivalent

510(k) numberK143435

Submission

Device name
Planmed Verity
Applicant
Planmed OY
Helsinki, FI
Received
December 1, 2014
Decision date
May 14, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAS – X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other 510(k)s with product code OAS

510(k)DeviceApplicantDecision
K261748Dental Cone-beam Computed Tomography (mDX-15P Series)OAS · Traditional Hefei Meyer Optoelectronic Technology, Inc.07/23/2026SE
K250839Dental X-ray SystemOAS · Traditional Changzhou Boen Zhongding Medical Technology Co.…06/11/2026SE
K260662Dental Cone Beam Computed Tomography SystemOAS · Special Yofo Medical Technology Co., Ltd.06/04/2026SE
K253935medXion NEXUSOAS · Traditional medXion Technologies, Inc.05/15/2026SE
K260462RCT800OAS · Special Ray Co., Ltd.04/09/2026SE
K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special VATECH Co., Ltd.03/31/2026SE
K252353myray ProXIma X6OAS · Traditional Cefla S.C.03/10/2026SE
K253959Primevision 3DOAS · Traditional Dentsply Sirona02/05/2026SE
K251798RCT700OAS · Traditional Ray Co., Ltd.11/25/2025SE
K251842Dental Computed Tomography X-ray SystemOAS · Traditional Fussen Technology Co., Ltd.11/13/2025SE

More from Fussen Technology Co., Ltd.

510(k)DeviceDecision
K250318Planmed XFISFV · Traditional 09/26/2025SE
K211720Planmed Clarity 2D, Planmed Clarify SMUE · Traditional 07/18/2022SE
K213278Planmed VerityOAS · Traditional 04/28/2022SE
K192317Planmed Clarity 2D and Clarity SMUE · Traditional 10/23/2020SE
K180918Planmed VerityOAS · Traditional 11/30/2018SE
K163328Planmed ClarityMUE · Traditional 12/28/2017SE
K121418Planmed VerityJAK · Traditional 02/01/2013SE
K121963Planmed Nuance DigiguideMUE · Traditional 11/21/2012SE
K042671Planmed Sophie Nuance ClassicIZH · Traditional 11/19/2004SE
K021945Planmed Sophie & Sophie Classic (with Digispot and Cytoguide)IZH · Traditional 02/21/2003SE

Questions and answers

When was Planmed Verity cleared by the FDA?

Planmed Verity (K143435) received a 510(k) decision of Substantially Equivalent on May 14, 2015, 164 days after the submission was received.

What is the product code of K143435?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.