FDA.reportPublic FDA data

Prodia Carbides

Primary DI
B868CDCP00021
Brand
Prodia Carbides
Company
ABRASIVE TECHNOLOGY, INC.
Model
2
Catalog number
CDCP0002
Device description
Carbide Dental Bur
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
B868CDCP00021PrimaryHIBCC0
B868CDCP00020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054028295
Device count
100
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B868CFES00171Two Striper379-023SCCFES00172025-09-01
B868CFES00181Two Striper379-023FCFES00182025-09-01
B868CDCP00011Prodia Carbides2CDCP00012026-05-06
B868CDCP00031Prodia Carbides4CDCP00032026-05-06
B868CDCP00041Prodia Carbides4CDCP00042026-05-06
B868CDCP00051Prodia Carbides6CDCP00052026-05-06
B868CDCP00061Prodia Carbides6CDCP00062026-05-06
B868CDCP00071Prodia Carbides245CDCP00072026-05-06
B868CDCP00081Prodia Carbides245CDCP00082026-05-06
B868CDCP00091Prodia Carbides330CDCP00092026-05-06
B868CDCP00101Prodia Carbides330CDCP00102026-05-06
B868CDCP00111Prodia Carbides557CDCP00112026-05-06
B868CDCP00121Prodia Carbides557CDCP00122026-05-06
B868CDCP00131Prodia Carbides331CDCP00132026-05-06
B868CDCP10011Prodia Carbides7378CDCP10012026-05-06
B868CDCP10021Prodia Carbides7379CDCP10022026-05-06
B868CDCP10031Prodia Carbides7404CDCP10032026-05-06
B868CDCP10041Prodia Carbides7406CDCP10042026-05-06
B868CDCP10051Prodia Carbides7408CDCP10052026-05-06
B868CDCP10061Prodia Carbides7664CDCP10062026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194409387AiraAIRA, LLCEJL2026-08-25
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00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
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00810226100213AiraAIRA, LLCEJL2026-08-25
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00810226100275AiraAIRA, LLCEJL2026-08-25
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00810226101081AiraAIRA, LLCEJL2026-08-25