FDA.report

MAXCUT DIAMOND BURS (6/pk) MED 862-012

Primary DI
D778100862120
Brand
MAXCUT DIAMOND BURS (6/pk) MED 862-012
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
100-862-12
Catalog number
100-862-12
Device description
MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 012; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
Published
2020-10-06
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
false

Related Records

Contact Domains

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D778100862121PrimaryHIBCC0
D778100862120Unit of UseHIBCC0

GMDN Terms

TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
6
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
true

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