FDA Registration
Active
🇺🇸 United States
DENTSPLY IH Inc.
Reg #: 1222802
·
FEI: 1000120733
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- DENTSPLY IH Inc.
- Registration Number
- 1222802
- FEI Number
- 1000120733
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 590 LINCOLN STREET
- City
- Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063734
Owner / Operator
- Firm Name
- DENTSPLY SIRONA INC
- Operator Number
- 2511302
- Address
- 221 WEST PHILADELPHIA ST., SUITE 60W
- City
- York
- State
- PA
- Postal Code
- 17401
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2017-10-27 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2006-08-17 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-11-20 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2001-10-23 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2017-10-27 |
Proprietary Names
Atlantis Temp Crown
ATLANTIS Crown
Atlantis Abutment in Zirconia for 3i Certain MicroMini Implants
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)