FDA.report

MAXCUT CARBIDE BUR (10/pk) FGSU # 701

Primary DI
D77811117410
Brand
MAXCUT CARBIDE BUR (10/pk) FGSU # 701
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
111-1741
Catalog number
111-1741
Device description
MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ; Shank: Friction Grip Surgical Length; For more information: https://www.scottsdental.com/catalog/product/view/id/17149/s/fg-surgical-carbide-burs-maxcut/
Published
2021-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77811117411PrimaryHIBCC0
D77811117410Unit of UseHIBCC0

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(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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