FDA.reportPublic FDA data

TriRock Dental

Primary DI
D170885012MTRD250
Brand
TriRock Dental
Company
TriRock Dental LLC
Model
885 012M
Catalog number
885-012M-TRD-25
Device description
TriRockDental FG #885-012M Diamond
Published
2025-12-09
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D170885012MTRD251PrimaryHIBCC0
D170885012MTRD250Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(844)763-5900sales@trirockdental.com

Regulatory Flags#

DUNS number
118701065
Device count
25
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D170835014FECO101ECO Dental835 014F835-014F-ECO-102025-12-09
D170885012MTRD251TriRock Dental885 012M885-012M-TRD-252025-12-09
D170835014FECO100ECO Dental835 014F835-014F-ECO-102025-12-09
D170368016CECO101ECO Dental368 016C368-016C-ECO-102025-12-05
D170368016MECO101ECO Dental368 016M368-016M-ECO-102025-12-05
D170368018MECO101ECO Dental368 018M368-018M-ECO-102025-12-05
D170368023CECO101ECO Dental368 023C368-023C-ECO-102025-12-05
D170368023CTRD101TriRock Dental368-023C368-023C-TRD-102025-12-05
D170368023CTRD502TriRock Dental368-023C368-023C-TRD-502025-12-05
D170368023FTRD101TriRock Dental368-023F368-023F-TRD-102025-12-05
D170368023FTRD502TriRock Dental368-023F368-023F-TRD-502025-12-05
D170368023MECO102ECO Dental368 023M368-023M-ECO-102025-12-05
D170368023MECO51ECO Dental368 023M368-023M-ECO-52025-12-05
D170368023MSUECO101ECO Dental368 023M SU368-023M-SU-ECO-102025-12-05
D170368023MTRD101TriRock Dental368-023M368-023M-TRD-102025-12-05
D170368023SCECO101ECO Dental368 023SC368-023SC-ECO-102025-12-05
D170368023SCSUECO101ECO Dental368 023SC SU368-023SC-SU-ECO-102025-12-05
D170368023SCTRD101TriRock Dental368-023SC368-023SC-TRD-102025-12-05
D170368023SCTRD502TriRock Dental368-023SC368-023SC-TRD-502025-12-05
D170379016FECO101ECO Dental379 016F379-016F-ECO-102025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243660995Alpen DiamondsDent4You AGDZP2026-09-04
07630243661237Alpen DiamondsDent4You AGDZP2026-09-04
07630243662470Alpen DiamondsDent4You AGDZP2026-09-04
07630243662494Alpen DiamondsDent4You AGDZP2026-09-04
07630243662517Alpen DiamondsDent4You AGDZP2026-09-04
07630243662531Alpen DiamondsDent4You AGDZP2026-09-04
07630243662555Alpen DiamondsDent4You AGDZP2026-09-04
07630243662579Alpen DiamondsDent4You AGDZP2026-09-04
07630243662593Alpen DiamondsDent4You AGDZP2026-09-04
07630243662616Alpen DiamondsDent4You AGDZP2026-09-04
07630243662630Alpen DiamondsDent4You AGDZP2026-09-04
07630243662654Alpen DiamondsDent4You AGDZP2026-09-04
07630243662678Alpen DiamondsDent4You AGDZP2026-09-04
07630243662692Alpen DiamondsDent4You AGDZP2026-09-04
07630243662715Alpen DiamondsDent4You AGDZP2026-09-04
07630243662739Alpen DiamondsDent4You AGDZP2026-09-04
07630243662753Alpen DiamondsDent4You AGDZP2026-09-04
07630243662777Alpen DiamondsDent4You AGDZP2026-09-04
07630243662791Alpen DiamondsDent4You AGDZP2026-09-04
07630243662814Alpen DiamondsDent4You AGDZP2026-09-04
07630243662838Alpen DiamondsDent4You AGDZP2026-09-04
07630243662852Alpen DiamondsDent4You AGDZP2026-09-04
07630243662876Alpen DiamondsDent4You AGDZP2026-09-04
07630243662890Alpen DiamondsDent4You AGDZP2026-09-04
07630243662913Alpen DiamondsDent4You AGDZP2026-09-04
07630243662937Alpen DiamondsDent4You AGDZP2026-09-04
07630243662951Alpen DiamondsDent4You AGDZP2026-09-04
07630243662975Alpen DiamondsDent4You AGDZP2026-09-04
07630243662999Alpen DiamondsDent4You AGDZP2026-09-04
07630243663019Alpen DiamondsDent4You AGDZP2026-09-04