FDA.reportPublic FDA data

TRUMATCH

Primary DI
05420060351235
Brand
TRUMATCH
Company
Materialise NV
Model
SD980.041
Catalog number
SD980.041
Device description
Bimaxillary Surgical Kit, Toothborne, Ti Splint, 2 Splints
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZJDRIVER, WIRE, AND BONE DRILL, MANUAL
JEYPLATE, BONE
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
JEYPlate, BoneDental2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170272000
K243637000
K260913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170272000TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV2017-08-08JEY
K243637000Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV2025-02-21DZJ
K260913000CMF Titanium SplintsMaterialise NV2026-10-09DZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420060351235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420060351235054200603512355420060351235

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy model/surgical guide kitA collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
373139427
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
05420060351242TRUMATCHSD980.042SD980.0422026-10-22
05420060351259TRUMATCHSD980.043SD980.0432026-10-22
05420060351266TRUMATCHSD980.044SD980.0442026-10-22
05420060351273TRUMATCHSD980.045SD980.0452026-10-22
05420060351280TRUMATCHSD980.046SD980.0462026-10-22
05420060351297TRUMATCHSD980.047SD980.0472026-10-22
05420060351303TRUMATCHSD980.048SD980.0482026-10-22
05420060351310TRUMATCHSD980.049SD980.0492026-10-22
05420060351327TRUMATCHSD980.050SD980.0502026-10-22
05420060351334TRUMATCHSD980.051SD980.0512026-10-22
05420060351341TRUMATCHSD980.052SD980.0522026-10-22
05420060351358TRUMATCHSD980.053SD980.0532026-10-22
05420060351365TRUMATCHSD980.054SD980.0542026-10-22
05420060351372TRUMATCHSD980.055SD980.0552026-10-22
05420060351389TRUMATCHSD980.056SD980.0562026-10-22
05420060351396TRUMATCHSD980.057SD980.0572026-10-22
05420060351402TRUMATCHSD980.058SD980.0582026-10-22
05420060351228TruMatch CMF Titanium 3D Printed SplintsSD980.030SD980.0302026-10-20
E314SHCLM010101Lima PSISHC-LM01-01-01SHC-LM01-01-012016-12-01
E314SHCLM020101Lima PSISHC-LM02-01-01SHC-LM02-01-012016-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351242TRUMATCHMaterialise NVDZJ2026-10-22
05420060351242TRUMATCHMaterialise NVJEY2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVDZJ2026-10-22
05420060351266TRUMATCHMaterialise NVDZJ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVJEY2026-10-22
05420060351273TRUMATCHMaterialise NVDZJ2026-10-22
05420060351273TRUMATCHMaterialise NVJEY2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVJEY2026-10-22
05420060351280TRUMATCHMaterialise NVDZJ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVJEY2026-10-22
05420060351297TRUMATCHMaterialise NVDZJ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVJEY2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVDZJ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVDZJ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVJEY2026-10-22
05420060351327TRUMATCHMaterialise NVDZJ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVJEY2026-10-22
05420060351334TRUMATCHMaterialise NVDZJ2026-10-22