FDA.reportPublic FDA data

TruAbutment DS

Primary DI
08800076451094
Brand
TruAbutment DS
Company
TRUABUTMENT INC.
Model
MCN-CS
Catalog number
MCN-CS
Published
2025-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800076451094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076451094088000764510948800076451094

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, custom-madeA custom-made device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]; an abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure and is manufactured for a specific patient.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
714-956-1488sales@truabutment.com

Regulatory Flags#

DUNS number
079875622
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800076421233TruAbutment DSOTM-CSOTM-CS2025-04-09
08800076432222TruAbutment DSOTM-CB2025-04-09
08800076432239TruAbutment DSOTR-CB2025-04-09
08800076432246TruAbutment DSDSU-CBDSU-CB2025-04-09
08800076432574TruAbutment DSZV3-CSZV3-CS2025-04-09
08800076432581TruAbutment DSDSU-CSDSU-CS2025-04-09
08800076432598TruAbutment DSZVN-CSZVN-CS2025-04-09
08800076432611TruAbutment DSZV4-CSZV4-CS2025-04-09
08800076432628TruAbutment DSZV5-CSZV5-CS2025-04-09
08800076432635TruAbutment DSNA3-CSNA3-CS2025-04-09
08800076432659TruAbutment DSNAR-CSNAR-CS2025-04-09
08800076432666TruAbutment DSNAW-CSNAW-CS2025-04-09
08800076432673TruAbutment DSNRN-CS2025-04-09
08800076432680TruAbutment DSNRR-CS2025-04-09
08800076432697TruAbutment DSNRW-CS2025-04-09
08800076432703TruAbutment DSNR6-CS2025-04-09
08800076432710TruAbutment DSAS3-CSAS3-CS2025-04-09
08800076432727TruAbutment DSAS4-CSAS4-CS2025-04-09
08800076432734TruAbutment DSAS5-CSAS5-CS2025-04-09
08800076432741TruAbutment DSAE30-CSAE30-CS2025-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516875691SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08