FDA Registration
Active
🇺🇸 United States
PROVIDE® IMPRESSION COPING 4.8MM(P) - 5.5MM POST
Reg #: 1036836
·
FEI: 1036836
·
Expires 2025
Products
1
Proprietary Names
39
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1036836
- FEI Number
- 1036836
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1148 Porter Ave
- City
- Haw River
- State
- NC
- ZIP
- 27258
- Country
- US
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2012-11-09 |
Proprietary Names
PROVIDE® IMPRESSION COPING 4.8MM(P) - 5.5MM POST
PROVIDE® IMPRESSION COPING WITH HOLES 4.8MM(P) - 4MM POST
DRILL STOP, 4.25MM-5.25MM X 18MM
PROVIDE® IMPRESSION COPING 6.5MM(P) - 4MM POST
DRILL STOP, 4.25MM-5.25MM X 13MM
PROVIDE® IMPRESSION COPING 6.5MM(P) - 5.5MM POST
DRILL STOP, 4.25MM-5.25MM X 8.5MM
PROVIDE® IMPRESSION COPING WITH HOLES 6.5MM(P) - 4MM POST
DRILL STOP, 2.3MM-3.25MM X 10MM
PROVIDE® IMPRESSION COPING 4.8MM(P) - 4MM POST
CONICAL EP® TWIST LOCK TM COPING
Drill Kit Tapered
MPLANT EP® PICK-UP COPING
CERTAIN® PICK-UP COPING
CERTAIN® STRAIGHT PICK UP COPING
CERTAIN® TWIST LOCK TM STRAIGHT TRANSFER COPING
CERTAIN® EP® TWIST LOCK TM COPING
Disposable Pilot Drill
CERTAIN® HEX TRY-IN SCREW
Disposable Twist Drill, Non-Hubbed
IMPLANT EP® TWIST LOCK TM COPING
Disposable Round Drill
CONICAL EP® PICK-UP COPING (NON-HEXED)
CERTAIN® STRAIGHT PICK-UP COPING
Disposable Twist Drill
Disposable Drill Kit
Standard Abutment Transfer Coping
Standard Abutment Pick-Up Coping
Drill Kit Parallel Walled
Conical Abutment Pick-Up Coping
IMPLANT EP® PICK-UP COPING
Index Coping - Surgical
Pick-Up Impression Coping
Disposable Countersink Drill
CONICAL EP® PICK-UP COPING (HEXED)
PROVIDE® IMPRESSION COPING WITH HOLES 4.8MM(P) - 5.5MM POST
DRILL STOP, 2.3MM-3.25MM X 20MM
DRILL STOP, 2.3MM-3.25MM X 15MM
PROVIDE® IMPRESSION COPING WITH HOLES 6.5MM(P) - 5.5MM POST
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)