Contract manufacturerDENTSPLY IH Inc. (Waltham, MA)MassachusettsDentalClass IClass II
DENTSPLY IH Inc.
Contract manufacturer ยท Waltham, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1222802 (openFDA record; or search FDA's registration database)
- FEI number
- 1000120733
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- DENTSPLY SIRONA INC (FDA owner/operator no. 2511302)
- Registered address
- 590 LINCOLN STREET, Waltham, MA 02451
- Contract listings
- 2 device listings, 2 product codes, first listed Oct 23, 2001
- 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 |
|---|
| NDP | Accessories, Implant, Dental, Endosseous | Class I | Dental | Contract manufacturing | Oct 23, 2001 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | Contract manufacturing | Mar 25, 2020 |
Other contract facilities of DENTSPLY SIRONA INC