← Back to catalogue

ProPlan CMF

FDA UDI

Class II (US FDA UDI)

by Materialise NV

Identity

Trade Name
ProPlan CMF FDA UDI
Generic Name
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Device Name
Patient Specific Instrument and Planning Kit, Orthognathic Kit, two Splints FDA UDI
Model / Reference
SD900.008 FDA UDI
Description
Patient Specific Instrument and Planning Kit, Orthognathic Kit, two Splints FDA UDI

Identifiers

Catalog Number
SD900.008 FDA UDI
Primary DI / UDI-DI
05420060350085 FDA UDI
510(k) Number
K103136 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

ProPlan CMF by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K103136 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Materialise NV

Sources (1)

  • FDA UDI 0b6b5aac-9972-4685-8f01-7623bb47288c 36 fields · synced Jun 8, 2026