FDA.reportPublic FDA data

DIAGNOdent 2095 perio tip

Primary DI
EKAV100416400
Brand
DIAGNOdent 2095 perio tip
Company
KaVo Dental GmbH
Model
1.004.1640
Catalog number
2095 perio tip
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K042394000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042394000DIAGNODENT PERIO TIP (ACCESSORY)Kavo America Corporation2005-08-02NBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100416400PrimaryHIBCC0

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
Handling Environment Temperature-30 Degrees Celsius80 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+18475506800customerservice@kavo.com

Regulatory Flags#

DUNS number
333710619
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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EKAV101375400SURGmatic S201 L Pro1.013.75401.013.75402020-01-24
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