FDA.report

Darby Dental Supply, LLC

Primary DI
00889813005705
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
FG 558
Catalog number
9525210
Device description
CARBIDE BURS FG 558 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

Related Records

Contact Domains

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889813005705PrimaryGS10
00889813005699Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813005705008898130057058898130057050889813005705
00889813005699008898130056998898130056990889813005699

GMDN Terms

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

Contacts

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

Regulatory Flags

DUNS number
825137818
Device count
10
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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