FDA.reportPublic FDA data

Quadrant Total Etch

Primary DI
E241FE1000
Brand
Quadrant Total Etch
Company
Cavex Holland B.V.
Model
FE100
Catalog number
FE100
Device description
Composite etching material
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984043000QUADRANT TOTAL ETCHCavex Holland BV1998-12-04EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E241FE1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-etching solutionAn acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+31(0)235307700m.vanderbor@cavex.nl

Regulatory Flags#

DUNS number
419980156
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E241FB3000Quadrant Uni-1-BondFB300FB3002026-03-30
E241FU020Quadrant Universal LC starterkit syringesFU02FU022026-03-30
E241FU200Quadrant Universal LC syringes A1FU20FU202026-03-30
E241FU210Quadrant Universal LC syringes A2FU21FU212026-03-30
E241FU220Quadrant Universal LC syringes A3FU22FU222026-03-30
E241FU230Quadrant Universal LC syringes A3.5FU23FU232026-03-30
E241FU240Quadrant Universal LC syringes B2FU24FU242026-03-30
E241FU250Quadrant Universal LC syringes C2FU25FU252026-03-30
E241FU260Quadrant Universal LC syringes OA2FU26FU262026-03-30
E241FU270Quadrant Universal LC syringes IFU27FU272026-03-30
E241FU280Quadrant Universal LC syringes A4FU28FU282026-03-30
E241FU290Quadrant Universal LC syringes B3FU29FU292026-03-30
E241FU300Quadrant Universal LC syringes C3FU30FU302026-03-30
E241FU600Quadrant Universal LC capsule A1FU60FU602026-03-30
E241FU610Quadrant Universal LC capsule A2FU61FU612026-03-30
E241FU620Quadrant Universal LC capsule A3FU62FU622026-03-30
E241FU630Quadrant Universal LC capsule A3.5FU63FU632026-03-30
E241FU640Quadrant Universal LC capsule B2FU64FU642026-03-30
E241FU650Quadrant Universal LC capsule C2FU65FU652026-03-30
E241BW9100Cavex Prophy Paste RegularBW910BW9102026-03-11

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