FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813013069
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9520965
Catalog number
9520965
Device description
FILM HOLDER 2 IN 1 DARBY
Published
2018-01-25
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
EGZHolder, film, x-ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813013069PrimaryGS10
00889813013052Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813013069008898130130698898130130690889813013069
00889813013052008898130130528898130130520889813013052

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, reusableA device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
825137818
Device count
3
DM exempt
true
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10371347019633Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
10304040192112CarinaHENRY SCHEIN, INC.EGZ2025-05-13
D00361765101XiosDentsply International Inc.EGZ2024-11-06
D00361765281XiosDentsply International Inc.EGZ2024-11-06
D00361765361XiosDentsply International Inc.EGZ2024-11-06
D00361765511XiosDentsply International Inc.EGZ2024-11-06
D003B10730511UniversalDentsply International Inc.EGZ2024-11-06
D003B10730521UniversalDentsply International Inc.EGZ2024-11-06
D003B10730531UniversalDentsply International Inc.EGZ2024-11-06
D003B10730541UniversalDentsply International Inc.EGZ2024-11-06
08717228440007DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440014DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440021DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440113DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440120DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440137DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440144DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440168DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440175DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440182DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440212DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440250CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440281CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440298CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440366CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440373CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440380CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440397CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440403CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440410CeflaDuPhaMed B.V.EGZ2023-11-23