FDA.reportPublic FDA data

Burs

Primary DI
D8130419101000
Brand
Burs
Company
DEN-MAT HOLDINGS, LLC
Model
041910100
Catalog number
041910100
Device description
POLISHING CUP COARSE
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
D8130419101000PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
18004336628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D813CR11010Nuance®CR1101CR11012016-09-24
D813CR11020Nuance®CR1102CR11022016-09-24
D813CR11030Nuance®CR1103CR11032016-09-24
D813CR11040Nuance®CR1104CR11042016-09-24
D813CR11060Nuance®CR1106CR11062016-09-24
D813CR11080Nuance®CR1108CR11082016-09-24
D813CR11120Nuance®CR1112CR11122016-09-24
D813CR11210Nuance®CR1121CR11212016-09-24
D813CR11350Nuance®CR1135CR11352016-09-24
D813CR11360Nuance®CR1136CR11362016-09-24
D813CR11370Nuance®CR1137CR11372016-09-24
D813CR11380Nuance®CR1138CR11382016-09-24
D813CR11400Nuance®CR1140CR11402016-09-24
D813CR11420Nuance®CR1142CR11422016-09-24
D813CR11430Nuance®CR1143CR11432016-09-24
D813CR11460Nuance®CR1146CR11462016-09-24
D813CR11550Nuance®CR1155CR11552016-09-24
D813CR12090Nuance®CR1209CR12092016-09-24
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194409387AiraAIRA, LLCEJL2026-08-25
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00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
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00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
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00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
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00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
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00810226100275AiraAIRA, LLCEJL2026-08-25
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00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25
00810226101081AiraAIRA, LLCEJL2026-08-25