FDA.reportPublic FDA data

DIAGNOcam Vision Full HD

Primary DI
EKAV101537000
Brand
DIAGNOcam Vision Full HD
Company
KaVo Dental GmbH
Model
1.015.3700
Catalog number
1.015.3700
Published
2024-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NBLLaser, fluorescence caries detection
NTKCaries detector, laser light, transmission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBLLaser, Fluorescence Caries DetectionDental2
NTKCaries Detector, Laser Light, TransmissionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV101537000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detector, optical induced fluorescenceA mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
333710619
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV057405000DIAGNOdent 20950.574.050020952016-09-26
EKAV100059540RONDOflex powder 50m (75g)1.000.5954NA2016-09-26
EKAV100059550RONDOflex powder 27m (75g)1.000.5955NA2016-09-26
EKAV100059560RONDOflex powder 50m (1000g)1.000.5956NA2016-09-26
EKAV100059570RONDOflex powder 27m (1000g)1.000.5957NA2016-09-26
EKAV100720000SonicFill Handpiece 349201.007.2000349202016-09-26
EKAV100620270SONICflex implant set A1.006.20271.006.20272025-01-31
EKAV100863840SONICflex prep crown round no. 97 A1.008.63841.008.63842025-01-31
EKAV100863860SONICflex prep crown plain no. 98 A1.008.63861.008.63862025-01-31
EKAV100835000EXPERTsurg LUX1.008.35001.008.35002016-09-26
EKAV100987570Tube Set S6001.009.8757S6002016-09-26
EKAV100880000INTRA LUX S600 LED1.008.80001.008.80002016-09-26
EKAV100910100SURGmatic S11 L1.009.10101.009.10102016-09-26
EKAV101375400SURGmatic S201 L Pro1.013.75401.013.75402020-01-24
EKAV101375410SURGmatic S201 XL Pro1.013.75411.013.75412020-01-24
EKAV101112130DIAGNOcam Vision Full HD1.011.12131.011.12132024-02-01
EKAV101315000DIAGNOcam Vision Full HD1.013.15001.013.15002024-02-01
EKAV101402800MASTERmatic LUX M45 L1.014.02801.014.02802024-02-01
EKAV100071050SONICflex cari-ex 0.8 No. 421.000.7105cari ex 0 8 No 422016-09-26
EKAV100071670SONICflex cari-ex 1.2 No. 431.000.7167cari ex 1 2 No 432016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E27668082030Primescan 2SIRONA Dental Systems GmbHNBL2025-11-21
E27668082030Primescan 2SIRONA Dental Systems GmbHNTK2025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbHNTK2025-10-23
E27668082450Primescan 2SIRONA Dental Systems GmbHNBL2025-10-23
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNBL2025-09-16
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNTK2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNBL2025-08-20
E27668558402Primescan 2SIRONA Dental Systems GmbHNTK2025-08-20
05902729754149TRIOS 53shape Trios A/SNBL2025-06-16
E27668020400Primescan 2SIRONA Dental Systems GmbHNBL2025-05-16
E27668020400Primescan 2SIRONA Dental Systems GmbHNTK2025-05-16
05902729753906TRIOS Ready Tip3shape Trios A/SNBL2025-05-06
06977585090143Fluorescence ModeCarl Zeiss Meditec (Suzhou) Co., Ltd.NBL2025-03-26
00816063023067iTero Lumina ProAlign Technology, Inc.NTK2025-03-06
04262352350035DI ScanZetta25 AGNBL2025-02-21
04262352350035DI ScanZetta25 AGNTK2025-02-21
10194665007928A-dec A-DEC, INC.NTK2025-02-11
08800043200090AIOBIOAIOBIO CO.,LTDNBL2024-12-02
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
08809941490008SmartoothSmartooth Co., Ltd.NBL2024-07-22
08809941490121SmartoothSmartooth Co., Ltd.NBL2024-07-22