FDA.reportPublic FDA data

MAXCUT DIAMOND BURS (6/pk) FINE 8856-016

Primary DI
D7781008856160
Brand
MAXCUT DIAMOND BURS (6/pk) FINE 8856-016
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
100-8856-16
Catalog number
100-8856-16
Device description
MAXCUT DIAMOND BURS (6/pk) Shape: Round End Taper; Size (in 1/10mm): 016; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/round-end-taper-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

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
D7781008856161PrimaryHIBCC0
D7781008856160Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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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D77810750580Scott's Select Patient Bibs107-5058107-50582024-08-27
D77819950610Scott's Select ColorFil Flow Single-Shade Prismatic199-5061199-50612024-08-27
D77819950630Scott's Select ColorFil Flow Blocker199-5063199-50632024-08-27
D77819950500Scott's Select ColorFil Single-Shade Prismatic199-5050199-50502024-08-26
D77819950530Scott's Select ColorFil Blocker199-5053199-50532024-08-26
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D77835055000Scott's Select Nitrile Gloves350-5500350-55002024-08-22
D77835055050Scott's Select Nitrile Gloves350-5505350-55052024-08-22
D77835055110Scott's Select Nitrile Gloves350-5511350-55112024-08-22
D77835086300Scott's Select Latex Gloves350-8630350-86302024-08-22
D77835086320Scott's Select Latex Gloves350-3632350-36322024-08-22
D77835086340Scott's Select Latex Gloves350-8634350-86342024-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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