FDA.reportPublic FDA data

Quadrant Universal LC syringes A4

Primary DI
E241FU280
Brand
Quadrant Universal LC syringes A4
Company
Cavex Holland B.V.
Model
FU28
Catalog number
FU28
Device description
Dental Composite Material color A4
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
K984041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984041000QUADRANT UNIVERSAL LCCavex Holland BV1998-12-04EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E241FU280PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
E241FE1000Quadrant Total EtchFE100FE1002026-03-30
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
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