FDA.reportPublic FDA data

Fluorescence Mode

Primary DI
06909262100043
Brand
Fluorescence Mode
Company
Carl Zeiss Suzhou Co., Ltd.
Model
000000-2165-387
Catalog number
000000-2165-387
Published
2018-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
NBLLaser, Fluorescence Caries Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBLLaser, Fluorescence Caries DetectionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171007000Fluorescence ModeCarl Zeiss Suzhou Co., Ltd.2018-05-03NBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06909262100043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909262100043069092621000436909262100043

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical microscopeA dental device intended to be used to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures via transmission of white and/or ultraviolet light. It typically consists of a control unit, eyepiece and magnification controls, and a white and fluorescent light module to enable differentiation of natural tooth material suggesting dental pathology (e.g., caries, plaque, calculus/tartar) or composite material used for dental repairs. It may also include a camera for still image capture or video recording.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528182577
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06909262200156Zeiss AxiovertAxiovert 5431030-9050-0002026-05-19
06909262061375OPMI® LUMERA® 30061372022-08-11
06909262060330EXTARO® 30060332022-08-11
06909262060347EXTARO® 30060342022-08-11
06909262060354EXTARO® 30060352022-08-11
06909262100104EXTARO® 300000000-2327-7552022-08-11
06909262200040ZEISS Axio VertAxio Vert.A1431030-9000-0002021-01-01
06909262200057ZEISS Axio VertAxio Vert.A1431030-9010-0002021-01-01
06909262200064ZEISS Axio VertAxio Vert.A1431030-9040-0002021-01-01
06909262200118ZEISS Axio LabAxio Lab.A1430037-9010-0002021-01-01
06909262200125ZEISS Axio LabAxio Lab.A1430037-9020-0002021-01-01
06909262200231ZEISS AxiolabAxiolab 5430037-9011-0002021-01-01
06909262200248ZEISS AxiolabAxiolab 5430037-9021-0002021-01-01
06909262200286ZEISS AxiolabAxiolab 5430037-9060-0002021-01-01
06909262200293ZEISS AxiolabAxiolab 5430037-9070-0002021-01-01
06909262200316ZEISS Axio LabAxio Lab.A1430037-9000-0002021-01-01
06909262200323ZEISS AxioscopeAxioscope 5430035-9032-0002021-01-01
06909262200330ZEISS AxioscopeAxioscope 5430035-9061-0002021-01-01
06909262200378ZEISS AxioscopeAxioscope 5430035-9201-0002021-01-01
06909262200422ZEISS AxioscopeAxioscope 5430035-9261-0002021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E27668082030Primescan 2SIRONA Dental Systems GmbHNBL2025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbHNBL2025-10-23
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNBL2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNBL2025-08-20
05902729754149TRIOS 53shape Trios A/SNBL2025-06-16
E27668020400Primescan 2SIRONA Dental Systems GmbHNBL2025-05-16
05902729753906TRIOS Ready Tip3shape Trios A/SNBL2025-05-06
06977585090143Fluorescence ModeCarl Zeiss Meditec (Suzhou) Co., Ltd.NBL2025-03-26
04262352350035DI ScanZetta25 AGNBL2025-02-21
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-12-03
08800043200090AIOBIOAIOBIO CO.,LTDNBL2024-12-02
08809941490008SmartoothSmartooth Co., Ltd.NBL2024-07-22
08809941490121SmartoothSmartooth Co., Ltd.NBL2024-07-22
08809941490084SmartoothSmartooth Co., Ltd.NBL2024-07-22
03760278267587ACTEONSOPRONBL2024-05-02
EKAV101112130DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-02-01
EKAV101315000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-02-01
00858197004062Ortek Therapeutics, Inc. ORTEK THERAPEUTICS, INCNBL2022-12-21
05902729753661TRIOS3shape Trios A/SNBL2022-09-26
05902729753753TRIOS3shape Trios A/SNBL2022-09-26
05902729753746TRIOS3shape Trios A/SNBL2022-09-26
05902729753678TRIOS3shape Trios A/SNBL2022-09-26
05902729753685TRIOS3shape Trios A/SNBL2022-09-26
05902729753722TRIOS 53shape Trios A/SNBL2022-09-26
05902729753739TRIOS 53shape Trios A/SNBL2022-09-26
05902729753760TRIOS3shape Trios A/SNBL2022-09-26
05902729753777TRIOS3shape Trios A/SNBL2022-09-26
05902729753784TRIOS3shape Trios A/SNBL2022-09-26
E247J27121CamX Spectra Interchangeable HeadDÜRR DENTAL SENBL2022-03-04
08800025400135InspireGOOD DOCTORS CO., LTD.NBL2020-11-13