FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813025710
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9521208
Device description
Flowable Composite 1.2g A3.5
Published
2019-09-20
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
K833810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833810000CURAY-MATCH PAINT-ON COMPOSITE RESTORScientific Pharmaceuticals, Inc.1984-02-21EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813025710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813025710008898130257108898130257100889813025710

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis veneer resinA dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags#

DUNS number
825137818
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
00889813067994Darby Dental Supply, LLC525879552587952026-02-12
00889813068007Darby Dental Supply, LLC525879652587962026-02-12
00889813068021Darby Dental Supply, LLC525879752587972026-02-12
00889813068038Darby Dental Supply, LLC525879852587982026-02-12
00889813068045Darby Dental Supply, LLC525879952587992026-02-12
00889813068052Darby Dental Supply, LLC525879052587902026-02-12
00889813068069Darby Dental Supply, LLC525879152587912026-02-12
00889813068076Darby Dental Supply, LLC525879252587922026-02-12
00889813068083Darby Dental Supply, LLC525879352587932026-02-12
00889813068090Darby Dental Supply, LLC525879452587942026-02-12
00889813048566Darby Dental Supply, LLC943020394302032022-07-18
00889813048580Darby Dental Supply, LLC943020494302042022-07-18
00889813048610Darby Dental Supply, LLC943020594302052022-07-18
00889813048672Darby Dental Supply, LLC943021094302102022-07-18
00889813048696Darby Dental Supply, LLC943021194302112022-07-18
00889813048719Darby Dental Supply, LLC943021294302122022-07-18
00889813048443Darby Dental Supply, LLC943020294302022022-07-18
00889813048511Darby Dental Supply, LLC943020194302012022-07-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208477825Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-10-19
07615208477832Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-10-19
00810111543644QuantiumBISCO INC.EBF2026-10-12
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBF2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00197998226724Solventum™ Protemp™Solventum Germany GmbHEBF2026-10-08
08806383540995DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541008DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541015DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541022DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541039DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541046DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541053DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541060DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541091DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541107DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541114DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541121DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541138DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541145DIAFILDiaDent Group InternationalEBF2026-10-07