Contract manufacturer3Shape Inc. (Morrisville, NC)North CarolinaDentalClass II
3Shape Inc.
Contract manufacturer ยท Morrisville, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3015193486 (openFDA record; or search FDA's registration database)
- FEI number
- 3015193486
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- 3Shape A/S (FDA owner/operator no. 10023901)
- Registered address
- 2800 Perimeter Park Drive, Suite E, Morrisville, NC 27560
- Contract listings
- 3 device listings, 2 product codes, first listed Dec 20, 2007
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| NBL | Light-Induced Fluorescence Caries Detector | Class II | Dental | Contract manufacturing | Sep 24, 2022 |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class II | Dental | Contract manufacturing | Dec 20, 2007 |