FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813006283
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
FG 331
Catalog number
9525356
Device description
CARBIDE BURS FG 331 DARBY
Published
2018-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813006283PrimaryGS10
00889813005491Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813006283008898130062838898130062830889813006283
00889813005491008898130054918898130054910889813005491

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA 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 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
100
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#

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

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Primary DI, Brand, Company table
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D7717276421Dental CityICP, INC.EJL2026-05-26
D7717276641Dental CityICP, INC.EJL2026-05-26
D7717276761Dental CityICP, INC.EJL2026-05-26