VistaCam iX Proof

Q: When was VistaCam iX Proof cleared by the FDA?

VistaCam iX Proof (K150672) received a 510(k) decision of Substantially Equivalent on January 27, 2016, 317 days after the submission was received.

Q: What is the product code of K150672?

The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.

FDA 510(k) K150672 · Durr Dental AG

Substantially Equivalent

510(k) numberK150672

Submission

Device name: VistaCam iX Proof
Applicant: Durr Dental AG
Bietigheim-Bissingen, DE
Received: March 16, 2015
Decision date: January 27, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NBL – Light-Induced Fluorescence Caries Detector
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.1745
Specialty: Dental

Other 510(k)s with product code NBL

510(k)	Device	Applicant	Decision
K252464	Surgical Microscope (OMS2360, OMS2380)NBL · Traditional	Zumax Medical Co., Ltd.	04/28/2026SE
K242103	TRIOS Ready TipNBL · Traditional	3Shape TRIOS A/S	04/04/2025SE
K221275	Qraycam PRONBL · Traditional	AIOBIO Co., Ltd.	09/04/2024SE
K231722	SmarToothNBL · Traditional	Smartooth Co., Ltd.	05/01/2024SE
K223470	C50NBL · Traditional	Sopro	12/14/2023SE
K221249	L1P-1F (Trios 5)NBL · Traditional	3Shape TRIOS A/S	09/16/2022SE
K183471	IC-WHCD100 (Inspire)NBL · Traditional	Good Doctors Co., Ltd.	07/02/2020SE
K171007	Fluorescence ModeNBL · Traditional	Carl Zeiss Suzhou Co., Ltd.	05/03/2018SE
K170822	Electronic Caries DetectorNBL · Traditional	Ortek Therapeutics, Inc.	09/11/2017SE
K121685	SoprocareNBL · Traditional	Sopro	03/12/2013SE

More from Sopro

510(k)	Device	Decision
K250947	VistaSoft 4.0 and VisionX 4.0QIH · Traditional	08/27/2025SE
K232487	Provecta 3D Prime and Provecta 3D Prime CephOAS · Special	09/14/2023SE
K230095	ScanX Swift 2.0, ScanX Swift View 2.0MUH · Special	02/06/2023SE
K213326	VisionX 3.0LLZ · Special	11/02/2021SE
K203116	SensorXMUH · Traditional	03/19/2021SE
K193139	ProVecta 3D Prime CephOAS · Traditional	03/05/2020SE
K192743	VisionX 2.4LLZ · Traditional	10/31/2019SE
K190629	DBSWIN and VISTAEASY Imaging SoftwareLLZ · Traditional	04/01/2019SE
K181432	ProVectra 3D Prime with VistaSoftOAS · Traditional	08/02/2018SE
K143290	DBSWIN and VistaEasy Imaging SoftwareLLZ · Traditional	02/18/2016SE

Questions and answers

When was VistaCam iX Proof cleared by the FDA?

VistaCam iX Proof (K150672) received a 510(k) decision of Substantially Equivalent on January 27, 2016, 317 days after the submission was received.

What is the product code of K150672?

The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.