FDA.report

Darby Dental Supply, LLC

Primary DI
10889813057763
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
5250414
Catalog number
5250414
Device description
STERILE CARBIDE BUR RA8
Published
2022-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889813057766PrimaryGS10
10889813057763Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813057766008898130577668898130577660889813057766
1088981305776310889813057763

GMDN Terms

TermDefinition
Carbide dental bur, single-useA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags

DUNS number
825137818
Device count
25
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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10889813067823Darby Dental Supply, LLC95531482025-07-02

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Primary DIBrandCompanyProduct codePublished
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00810126508294Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508300Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508324Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
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