VSP System

FDA UDI

Class II (US FDA UDI)

by 3d Systems, Inc.

Identity

Trade Name: VSP System FDA UDI
Generic Name: Custom-made organ/bone anatomy model FDA UDI
Device Name: A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. FDA UDI
Model / Reference: Perfected Maxilla Model FDA UDI
Description: A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. FDA UDI

Identifiers

Primary DI / UDI-DI: 00816847021197 FDA UDI
510(k) Number: K120956 FDA UDI
K133907 FDA UDI
K192192 FDA UDI
K210347 FDA UDI
FDA Product Code: LLZ FDA UDI
DZJ FDA UDI
GMDN Term: Custom-made organ/bone anatomy model FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
872.4120 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Custom-made organ/bone anatomy model

VSP System by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made organ/bone anatomy model.

IPS — KLS-Martin L.P. · Class I
IPS — KLS-Martin L.P. · Class I
Match Point System — Materialise NV · Class II
ProPlan CMF — Materialise NV · Class I
ProPlan CMF — Materialise NV · Class I
ProPlan CMF — Materialise NV · Class I
Patient-Fitted TMJ Reconstructive Prosthesis System — TMJ Solutions, LLC · Class III
IPS — KLS-Martin L.P. · Class I

Cleared under the same submission

K120956 also covers:

K133907 also covers:

K192192 also covers:

K210347 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: 3d Systems, Inc.

Sources (1)

FDA UDI 71e093a8-2992-47b1-858a-a1b03a349f29 35 fields · synced Jun 6, 2026