FDA.reportPublic FDA data

CamX Spectra Caries Detection Aid

Primary DI
D678G41000
Brand
CamX Spectra Caries Detection Aid
Company
AIR TECHNIQUES, INC.
Model
G4100
Device description
The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K090169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090169000SPECTRA FLUORESCENCE CARIES DETECTION DEVICEAir Techniques, Inc.2009-08-18NBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D678G40001PackageHIBCC1In Commercial Distribution
DG78G41001PackageHIBCC1In Commercial Distribution
D678G41000PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8002478324xx@xx.xx

Regulatory Flags#

DUNS number
043835081
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
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D678732482K1ScanX Barrier Envelopes73248-2K2023-09-12
D6787324801ScanX Barrier Envelopes73248-02019-08-23
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D678AS1200AirStar Clinical Air CompressorAS1202023-06-14
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Primary DI, Brand, Company table
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EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-12-03
08800043200090AIOBIOAIOBIO CO.,LTDNBL2024-12-02
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EKAV101315000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-02-01
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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
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