FDA.reportPublic FDA data

MAXCUT DIAMOND BURS (6/pk) CRS 6850-012

Primary DI
D7781006850121
Brand
MAXCUT DIAMOND BURS (6/pk) CRS 6850-012
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
100-6850-12
Catalog number
100-6850-12
Device description
MAXCUT DIAMOND BURS (6/pk) Shape: Round End Taper; Size (in 1/10mm): 012; Grit: Coarse; 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

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
D7781006850121PrimaryHIBCC0
D7781006850120Unit 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D77819910111SCOTT'S SELECT 37% ETCH GEL 1.2ml SYRINGE KIT 4/pk199-1011199-10112017-05-24
D77819910121SCOTT'S SELECT 37% ETCH GEL 12gm BULK SYRINGE KIT199-1012199-10122017-05-24
D77819910131SCOTT'S SELECT 37% ETCH GEL 50mL JUMBO SYRINGE KIT199-1013199-10132017-05-24
D77819910141SCOTT'S SELECT 37% ETCH GEL 50mL JUMBO SYRINGE199-1014199-10142017-05-24
D77819910081SCOTT'S SELECT AUTOMIX 25ml TEMP CEMENT NE199-1008199-10082017-06-02
D77819910451SCOTT'S SELECT TEMP AUTOMIX NE 11gm199-1045199-10452017-06-02
D77818810880SCOTT'S MORREL CROWN REMOVER w/ 4-TIPS188-1088188-10882021-02-27
D77818820080SCOTT'S CROWN GRABBER REMOVER188-2008188-20082021-02-27
D77818831030SCOTT'S K-STYLE CROWN REMOVER w/ RUBBER TIPS188-3103188-31032021-02-27
D77810702991Scott's Select Non-Woven Sponges 2 x 2 107-0299107-02992024-08-27
D77810704441Scott's Select Non-Woven Sponges 4 x 4107-0444107-04442024-08-27
D77810320011Scott's Select Mirror Handle Cone Socket Octagonal103-2001103-20012024-09-05
D77810320021Scott's Select Mirror Handle Cone Socket Round103-2002103-20022024-09-05
D77810320031Scott's Select Mouth Mirror Front Surface #3103-2003103-20032024-09-05
D77810320041Scott's Select Mouth Mirror Front Surface #4103-2004103-20042024-09-05
D77810320051Scott's Select Mouth Mirror Front Surface #5103-2005103-20052024-09-05
D77810750051"SCOTT'S SYRINGE SLEEVE 2.5""x10"" (500) CLEAR"107-5005107-50052021-02-27
D77810750061"SCOTT'S SYRINGE SLEEVE 2.5""x10"" (500) BLUE"107-5006107-50062021-02-27
D77810750071"SCOTT'S FULL CHAIR COVER 29"" X 80"" (125/bx)"107-5007107-50072021-02-27
D77810750091"SCOTT'S HALF CHAIR CVR 27.5"" X 24"" (225/bx)"107-5009107-50092021-02-27

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