FDA.reportPublic FDA data

A-dec

Primary DI
10194665007928
Brand
A-dec
Company
A-DEC, INC.
Model
54.1041.00
Catalog number
54.1041.00
Device description
KaVo DIAGNO cam Vision Full HD camera Kit
Published
2025-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NTKCaries Detector, Laser Light, Transmission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTKCaries Detector, Laser Light, TransmissionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182712000DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH2019-11-23NTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10194665007928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019466500792810194665007928

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral cameraAn electro-optical device designed for image and/or video capture of the teeth and other intraoral anatomy, to assist with the diagnosis/management of dental/intraoral conditions (e.g., caries, plaque, calculus). It may be provided with specialized camera heads for specific types of examination (e.g., acquiring high resolution pictures/videos, emitting violet or infrared light), as well as camera holders and cables; it connects to an off-the-shelf computer (not included) for the power/processing/display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009617473
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10194665008857A-decS76S762026-05-07
10194665008444A-dec54.0924.0154.0924.012026-02-19
10194665008475A-dec54.1073.0054.1073.002026-02-19
10194665008482A-dec54.1073.0154.1073.012026-02-19
10194665008499A-dec54.1074.0054.1074.002026-02-19
10194665008505A-dec54.1074.0154.1074.012026-02-19
10194665008512A-dec54.1051.0054.1051.002026-02-19
10194665008529A-dec54.1052.0054.1052.002026-02-19
10194665008550A-dec54.1076.0054.1076.002026-02-19
10194665004460A-dec54.0865.0054.0865.002022-11-07
10194665008697A-dec3453452026-02-17
10194665008666A-decAMDUWLAMDUWL2025-09-30
10194665008383A-dec311xlc311xlc2025-09-18
10194665006587A-dec311FLT311FLT2025-05-19
10194665006594A-dec511FLT511FLT2025-05-19
10194665007935ActeonC202025-05-15
10194665008321A-decNo Version or Model Number54.1042.002025-05-15
10194665008345A-decNo Version or Model Number54.1043.002025-05-15
10194665007911A-dec346134612025-01-24
10194665007164A-dec54.1003.0054.1003.002024-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E27668082030Primescan 2SIRONA Dental Systems GmbHNTK2025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbHNTK2025-10-23
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNTK2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNTK2025-08-20
E27668020400Primescan 2SIRONA Dental Systems GmbHNTK2025-05-16
00816063023067iTero Lumina ProAlign Technology, Inc.NTK2025-03-06
04262352350035DI ScanZetta25 AGNTK2025-02-21
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-12-03
00816063022213iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
00816063022237iTero Lumina Pro MobileAlign Technology, Inc.NTK2024-11-19
00816063022268iTero Lumina Pro intraoral scanning unitAlign Technology, Inc.NTK2024-11-19
00816063022329iTero Lumina Pro DOAAlign Technology, Inc.NTK2024-11-19
00816063022428iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022442iTero Lumina Pro Mobile UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022466iTero Lumina Pro UpgradeAlign Technology, Inc.NTK2024-11-19
00816063022589iTero Lumina Pro Wand Barrier SleevesAlign Technology, Inc.NTK2024-11-19
00816063022657iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
00816063022664iTero Lumina ProAlign Technology, Inc.NTK2024-11-19
EKAV101112130DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-02-01
EKAV101315000DIAGNOcam Vision Full HDKaVo Dental GmbHNTK2024-02-01
00858809006224Planmeca Emerald SD4D TECHNOLOGIES, LLCNTK2022-07-06
EKAV100270000DIAGNOdent pen 2190KaVo Dental GmbHNTK2022-04-15
E247J27131CamX Proxi Interchangeable HeadDÜRR DENTAL SENTK2022-03-04
00816063020691iTero Element 5D Plus cart configuration Align Technology, Inc.NTK2021-06-04
00816063020707iTero Element 5D Plus US cart configurationAlign Technology, Inc.NTK2021-06-04
00816063020721iTero Element 5D Plus upgrade cart configurationAlign Technology, Inc.NTK2021-06-04
00816063020745iTero Element 5D Plus mobile configurationAlign Technology, Inc.NTK2021-06-04
00816063020752iTero Element 5D Plus US mobile configurationAlign Technology, Inc.NTK2021-06-04
00816063020776iTero Element 5D Plus upgrade mobile configurationAlign Technology, Inc.NTK2021-06-04
00816063020783iTero Element 5D Plus US wand upgradeAlign Technology, Inc.NTK2021-06-04