FDA.report

ECO Dental

Primary DI
D170862012SCECO100
Brand
ECO Dental
Company
TriRock Dental LLC
Model
862 012SC
Catalog number
862-012SC-ECO-10
Device description
ECO Dental FG 862-012SC Diamond
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

Related Records

Contact Domains

Product Codes

CodeName
DZPINSTRUMENT, DIAMOND, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D170862012SCECO101PrimaryHIBCC0
D170862012SCECO100Unit of UseHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(844)763-5900sales@trirockdental.com

Regulatory Flags

DUNS number
118701065
Device count
10
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 DIBrandModelCatalogPublished
D170835014FECO100ECO Dental835 014F835-014F-ECO-102025-12-09
D170885012MTRD250TriRock Dental885 012M885-012M-TRD-252025-12-09
D17031P23MTRD10TriRock Dental31P-2.3-M31P-2.3-M-TRD-12025-12-05
D170368016CECO100ECO Dental368 016C368-016C-ECO-102025-12-05
D170368016MECO100ECO Dental368 016M368-016M-ECO-102025-12-05
D170368018MECO100ECO Dental368 018M368-018M-ECO-102025-12-05
D170368023CECO100ECO Dental368 023C368-023C-ECO-102025-12-05
D170368023CTRD100TriRock Dental368-023C368-023C-TRD-102025-12-05
D170368023CTRD500TriRock Dental368-023C368-023C-TRD-502025-12-05
D170368023FTRD100TriRock Dental368-023F368-023F-TRD-102025-12-05
D170368023FTRD500TriRock Dental368-023F368-023F-TRD-502025-12-05
D170368023MECO100ECO Dental368 023M368-023M-ECO-102025-12-05
D170368023MECO50ECO Dental368 023M368-023M-ECO-52025-12-05
D170368023MSUECO100ECO Dental368 023M SU368-023M-SU-ECO-102025-12-05
D170368023MTRD100TriRock Dental368-023M368-023M-TRD-102025-12-05
D170368023SCECO100ECO Dental368 023SC368-023SC-ECO-102025-12-05
D170368023SCSUECO100ECO Dental368 023SC SU368-023SC-SU-ECO-102025-12-05
D170368023SCTRD100TriRock Dental368-023SC368-023SC-TRD-102025-12-05
D170368023SCTRD500TriRock Dental368-023SC368-023SC-TRD-502025-12-05
D170379016FECO100ECO Dental379 016F379-016F-ECO-102025-12-05

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