Skip to content

VSP System Repositioned Mandible Model

by 3D Systems, Inc.

VSP System Repositioned Mandible Model is a custom-made organ/bone anatomy model (FDA Class II) made by 3D Systems, Inc., cleared under FDA 510(k) K210347 on 26 Apr 2021 (3 earlier submissions) and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00816847021135), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210347 Date26 Apr 2021DecidedStatusActive
United StatesGUDID listing Number00816847021135 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210347 decided 26 Apr 2021 Active· +3 more in the status table
  • FDA GUDID UDI-DI 00816847021135 listed 12 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1510-2022 FDA Class II initiated 17 May 2022

    Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

Timeline

6 dated events

  1. Cleared FDA 510(k) K120956
  2. Cleared FDA 510(k) K133907
  3. Listed FDA GUDID 00816847021135
  4. Cleared FDA 510(k) K192192
  5. Cleared FDA 510(k) K210347
  6. Recall initiated FDA recalls Z-1510-2022

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VSP System
Generic name
Custom-made organ/bone anatomy model
Model / reference
Repositioned Mandible Model
Primary DI / UDI-DI
00816847021135
510(k) Number
FDA product code
LLZ, DZJ
GMDN term
Custom-made organ/bone anatomy model
Device class
Class II
Regulation number
892.2050, 872.4120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Related devices

Category: Custom-made organ/bone anatomy model

Cleared under the same submission (K120956)

and 8 more cleared under K120956

Cleared under the same submission (K133907)

and 8 more cleared under K133907

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from 3D Systems, Inc.

See all devices from 3D Systems, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)