FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813000915
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
SDCD
Catalog number
9515018
Device description
CARIES DETECTOR BLUE 12ML
Published
2016-06-21
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
LFCDEVICE, CARIES DETECTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFCDevice, Caries DetectionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813000915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813000915008898130009158898130009150889813000915

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries removal solutionA liquid substance used in dentistry to detect and remove caries from an infected tooth. 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
1
DM exempt
true
Lot or batch
true
Expiration 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

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00817051021690ExposeCENTRIX, INC.LFC2023-12-22
00817051021706ExposeCENTRIX, INC.LFC2023-12-22
00817051021744ExposeCENTRIX, INC.LFC2023-12-22
00817051022338ExposeCENTRIX, INC.LFC2023-12-22
00817051022345ExposeCENTRIX, INC.LFC2023-12-22
00817051022352ExposeCENTRIX, INC.LFC2023-12-22
00817051022369ExposeCENTRIX, INC.LFC2023-12-22
00858197004062Ortek Therapeutics, Inc. ORTEK THERAPEUTICS, INCLFC2022-12-21
10818207020854Vista Blue Unit Dose KitVista DentalLFC2021-01-29
10818207020861Vista Blue Fracture Detection KitVista DentalLFC2021-01-29
00304040027820Henry ScheinHENRY SCHEIN, INC.LFC2020-08-24
20304040027824Henry ScheinHENRY SCHEIN, INC.LFC2020-08-24
00304040133422Henry ScheinHENRY SCHEIN, INC.LFC2020-07-30
10304040133429Henry ScheinHENRY SCHEIN, INC.LFC2020-07-30
10818207020014Vista-Red Caries Indicator Standard PackVista DentalLFC2018-07-31
10818207020021Vista-Red Caries Refill PackVista DentalLFC2018-07-31
10818207020038Vista-Red Caries Value PackVista DentalLFC2018-07-31
10818207020045Vista-Red Caries Unit DoseVista DentalLFC2018-07-31
10818207020069Vista-Green Caries Indicator Standard KitVista DentalLFC2018-07-31
10818207020076Vista-Green Caries Indicator Refill PackVista DentalLFC2018-07-31
10818207020083Vista-Green Caries Indicator Value PackVista DentalLFC2018-07-31
10818207020090Vista-Green Unit DoseVista DentalLFC2018-07-31
10818207020380Mixing WellsVista DentalLFC2018-07-31
10818207020052Vista-Red Caries 10ml KitVista DentalLFC2018-06-19
10818207020106Vista-Green Caries Indicator 10ml KitVista DentalLFC2018-06-19
EKUR000220KA1CARIES DETECTORKURARAY NORITAKE DENTAL INC.LFC2017-02-17
D8097601RoydentROYDENT DENTAL PRODUCTS INCLFC2016-10-07