FDA.reportPublic FDA data

ECO Dental

Primary DI
D170FG7901GECO1000
Brand
ECO Dental
Company
TriRock Dental LLC
Model
FG 7901G
Catalog number
FG7901G-ECO-100
Device description
ECO Dental FG #7901 Carbide
Published
2025-12-05
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
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D170FG7901GECO1002PrimaryHIBCC0
D170FG7901GECO1000Unit 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

Contacts#

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

Regulatory Flags#

DUNS number
118701065
Device count
100
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
D170885012MTRD250TriRock Dental885 012M885-012M-TRD-252025-12-09
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

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Primary DI, Brand, Company table
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00810226101043AiraAIRA, LLCEJL2026-08-25
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00810226101081AiraAIRA, LLCEJL2026-08-25