FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813050293
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9533534
Catalog number
9533534
Device description
ABSORB PTS BULK #45
Published
2021-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKNPOINT, PAPER, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813051818PrimaryGS10
00889813050293Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813051818008898130518188898130518180889813051818
00889813050293008898130502938898130502930889813050293

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use 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
200
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
10889813067960Darby Dental Supply, LLC95531292025-07-12
10889813067649Darby Dental Supply, LLC52584552025-07-02
10889813067663Darby Dental Supply, LLC95531332025-07-02
10889813067670Darby Dental Supply, LLC95531342025-07-02
10889813067687Darby Dental Supply, LLC95531352025-07-02
10889813067694Darby Dental Supply, LLC95531362025-07-02
10889813067700Darby Dental Supply, LLC95531372025-07-02
10889813067717Darby Dental Supply, LLC95531392025-07-02
10889813067724Darby Dental Supply, LLC95531382025-07-02
10889813067731Darby Dental Supply, LLC95531402025-07-02
10889813067755Darby Dental Supply, LLC95531412025-07-02
10889813067762Darby Dental Supply, LLC95531422025-07-02
10889813067779Darby Dental Supply, LLC95531432025-07-02
10889813067786Darby Dental Supply, LLC95531442025-07-02
10889813067793Darby Dental Supply, LLC95531452025-07-02
10889813067809Darby Dental Supply, LLC95531462025-07-02
10889813067816Darby Dental Supply, LLC95531472025-07-02
10889813067823Darby Dental Supply, LLC95531482025-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978880220006ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220013ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220020ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220037ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220044ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220051ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220068ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220075ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220082ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220099ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220105ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220112ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220129ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220136ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220143ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220150ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220167ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220174ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220181ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220198ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220204ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220211ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220228ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220235ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220242ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220259ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220266ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220273ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220280ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
06978880220297ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09