FDA Registration Active 🇺🇸 United States

Hahn™ Tapered Implant Healing Abutment 5 mmH - 04.3 Implant

Reg #: 2022435 · FEI: 2022435 · Expires 2025
Products
1
Proprietary Names
69
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Sterigenics U.S., LLC
Registration Number
2022435
FEI Number
2022435
Status
Active
Expiry Year
2025
Initial Importer
No
Address
1401 Morgan Cir
City
Tustin
State
CA
ZIP
92780
Country
US

Regulatory Submissions

510(k) Number
K143353

Owner / Operator

Firm Name
Sotera Health LLC
Operator Number
10029425
Address
2015 Spring Road, Suite 650
City
Oak Brook
State
IL
Postal Code
60523
Country
US
Correspondent
Karen Whaley-Krumins

Products

Device Name Product Code
Implant, Endosseous, Root-Form DZE

Proprietary Names

Hahn™ Tapered Implant Healing Abutment 5 mmH - 04.3 Implant Hahn Tapered Implant Multi-Unit Abut. 2.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant 05 x 16 mm Hahn™ Tapered Implant 03.5 x 11.5 mm Hahn™ Tapered Implant 03 x 16 mm Hahn™ Tapered Implant 05 x 13 mm Hahn™ Tapered Implant 03 x 13 mm Hahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 05 Implant Hahn™ Tapered Implant Healing Abutment 3 mmH - 07 Implant Hahn™ Tapered Implant Healing Abutment 5 mmH - 03 Implant Hahn Tapered Implant 30 Multi-Unit Abutment 4.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant Healing Abutment 7 mmH - 04.3 Implant Hahn™ Tapered Implant Healing Abutment 3 mmH - 03.5 Implant Hahn™ Tapered Implant 04.3 x 10 mm Hahn™ Tapered Implant Healing Abutment 3 mmH - 03 Implant Hahn™ Tapered Implant Healing Abutment 5 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abut. 4.5 mmH - 05 Implant Hahn™ Tapered Implant 04.3 x 13 mm Hahn™ Tapered Implant 03.5 x 10 mm Hahn Tapered Implant Multi-Unit Abut. 2.5 mmH - 05 Implant Hahn Tapered Implant 30 Multi-Unit Abutment 3.5 mmH - 05 Implant Hahn Tapered Implant 30 Multi-Unit Abutment 3.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant 03.5 x 8 mm Hahn Tapered Implant 30 Multi-Unit Abut. 3.5 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abut. 3.5 mmH - 05 Implant Hahn Tapered Implant 17 Multi-Unit Abut. 3.5 mmH - 05 Implant Hahn™ Tapered Implant 04.3 x 8 mm Hahn Tapered Implant 30 Multi-Unit Abut. 3.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abut. 3.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant Healing Abutment 7 mmH - 03 Implant Hahn™ Tapered Implant Healing Abutment 5 mmH - 03.5 Implant Hahn Tapered Implant 17 Multi-Unit Abutment 3.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant 07 x 8 mm Hahn™ Tapered Implant Healing Abutment 5 mmH - 07 Implant Hahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abutment 1.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant Healing Abutment 3 mmH - 04.3 Implant Hahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 05 Implant Hahn™ Tapered Implant 07 x 10 mm Hahn Tapered Implant Multi-Unit Abut. 2.5 mmH - 03 Implant Hahn Tapered Implant 17 Multi-Unit Abutment 2.5 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abut. 3.5 mmH - 03 Implant Hahn™ Tapered Implant 03.5 x 16 mm Hahn™ Tapered Implant 03 x 11.5 mm Hahn™ Tapered Implant Healing Abutment 7 mmH - 03.5 Implant Hahn™ Tapered Implant 05 x 8 mm Hahn Tapered Implant Multi-Unit Abut. 1.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant Healing Abutment 3 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abutment 1.5 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abut. 1.5 mmH - 05 Implant Hahn Tapered Implant 17 Multi-Unit Abutment 2.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant 04.3 x 11.5 mm Hahn™ Tapered Implant 05 x 11.5 mm Hahn Tapered Implant 30 Multi-Unit Abutment 4.5 mmH - 05 Implant Hahn Tapered Implant 30 Multi-Unit Abut. 4.5 mmH - 05 Implant Hahn Tapered Implant 17 Multi-Unit Abut. 2.5 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 03 Implant Hahn Tapered Implant 30 Multi-Unit Abut. 4.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant 17 Multi-Unit Abut. 3.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant 17 Multi-Unit Abutment 3.5 mmH - 05 Implant Hahn™ Tapered Implant 07 x 11.5 mm Hahn™ Tapered Implant 03.5 x 13 mm Hahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 03 Implant Hahn Tapered Implant Multi-Unit Abutment 4.5 mmH - 05 Implant Hahn™ Tapered Implant 05 x 10 mm Hahn™ Tapered Implant 04.3 x 16 mm Hahn Tapered Implant 17 Multi-Unit Abut. 2.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant Healing Abutment 7 mmH - 05 Implant

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)