FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813020692
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9519067
Catalog number
9519067
Device description
Porcelin Etch Refill 1.2ml with tip
Published
2018-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K933766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933766000HIGH-Q-BONDSilmet U.S.A. Corp.1994-01-26EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813020692PrimaryGS10
00889813020685Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813020692008898130206928898130206920889813020692
00889813020685008898130206858898130206850889813020685

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis priming agentA material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.

Contacts#

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

Regulatory Flags#

DUNS number
825137818
Device count
4
DM exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
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

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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