Inclusive® Tapered Implant 5.2 mmD x 10 mmL x 4.5 mmP

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: K121406

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
Implant, Endosseous, Root-Form	DZE	Class 2	Dental	No	2021-06-23

Proprietary Names

Inclusive® Tapered Implant 5.2 mmD x 10 mmL x 4.5 mmP Reflect Rapid Healing Abutment 5.7 mmD x 3 mmH RP Inclusive® Tapered Implant 4.7 mmD x 13 mmL x 4.5 mmP Inclusive® Tapered Implant Healing Abutment 3 mmP x 3.7 mmD x 7 mmH Inclusive® Healing Abutment 3.5 x 3.5 x 3 mm Inclusive® Healing Abutment 4.5 x 5.7 x 5 mm Reflect Tapered Healing Abutment 3.5 Platform x 4.7 mmD x 5 mmH Inclusive Tapered Implant Healing Abut. 3.5 mmP x 3.5 mmD x 7 mmH Inclusive® Tapered Implant 3.7 mmD x 10 mmL x 3.5 mmP Inclusive Tapered Implant Healing Abut. 3.5 mmP x 4.7 mmD x 7 mmH Inclusive® Tapered Implant 3.7 mmD x 16 mmL x 3.5 mmP Reflect Rapid Healing Abutment 3.5 mmD x 5 mmH NP Inclusive® Tapered Implant 3.7 mmD x 11.5 mmL x 3.5 mmP Reflect Rapid Healing Abutment 4.7 mmD x 3 mmH NP Inclusive® Healing Abutment 4.5 x 5.7 x 3 mm Inclusive® Tapered Implant 5.2 mmD x 13 mmL x 4.5 mmP Inclusive® Tapered Implant 3.7 mmD x 8 mmL x 3.5 mmP Inclusive® Tapered Implant 4.7 mmD x 16 mmL x 4.5 mmP Inclusive® Tapered Implant 4.7 mmD x 10 mmL x 4.5 mmP Reflect Tapered Healing Abutment 4.5 Platform x 4.5 mmD x 3 mmH Inclusive® Tapered Implant 5.2 mmD x 11.5 mmL x 4.5 mmP Reflect Tapered Healing Abutment 3.5 Platform x 3.5 mmD x 3 mmH Reflect Tapered Healing Abutment 4.5 Platform x 5.7 mmD x 5 mmH Inclusive® Tapered Implant Healing Abutment 3 mmP x 3.7 mmD x 5 mmH Inclusive® Tapered Implant 3.7 mmD x 13 mmL x 3.5 mmP Reflect Rapid Healing Abutment 4.3 mmD x 3 mmH RP Inclusive® Tapered Implant 3.2 mmD x 16 mmL x 3 mmP Reflect Rapid Healing Abutment 3.5 mmD x 3 mmH NP Inclusive® Tapered Implant 4.2 mmD x 11.5 mmL x 3.5 mmP Inclusive® Tapered Implant 4.2 mmD x 10 mmL x 3.5 mmP Inclusive® Healing Abutment 3.5 x 4.7 x 3 mm Inclusive® Tapered Implant 5.2 mmD x 8 mmL x 4.5 mmP Inclusive® Tapered Implant 3.2 mmD x 8 mmL x 3 mmP Reflect Tapered Healing Abutment 3.5 Platform x 3.5 mmD x 5 mmH Inclusive® Tapered Implant 3.2 mmD x 10 mmL x 3 mmP Inclusive® Tapered Implant 3.2 mmD x 13 mmL x 3 mmP Inclusive Tapered Implant Healing Abut. 4.5 mmP x 5.7 mmD x 7 mmH Inclusive® Tapered Implant 3.2 mmD x 11.5 mmL x 3 mmP Inclusive® Tapered Implant 4.7 mmD x 8 mmL x 4.5 mmP Reflect Rapid Healing Abutment 5.7 mmD x 5 mmH RP Inclusive® Tapered Implant 4.7 mmD x 11.5 mmL x 4.5 mmP Inclusive® Tapered Implant 4.2 mmD x 16 mmL x 3.5 mmP Inclusive® Tapered Implant Healing Abutment 3 mmP x 3.7 mmD x 3 mmH Inclusive® Healing Abutment 4.5 x 4.5 x 5 mm Reflect Tapered Healing Abutment 4.5 Platform x 4.5 mmD x 5 mmH Reflect Rapid Healing Abutment 4.3 mmD x 5 mmH RP Inclusive® Tapered Implant 5.2 mmD x 16 mmL x 4.5 mmP Reflect Tapered Healing Abutment 4.5 Platform x 5.7 mmD x 3 mmH Inclusive Tapered Implant Healing Abut. 4.5 mmP x 4.5 mmD x 7 mmH Inclusive® Tapered Implant 4.2 mmD x 13 mmL x 3.5 mmP Inclusive® Healing Abutment 4.5 x 4.5 x 3 mm Reflect Rapid Healing Abutment 4.7 mmD x 5 mmH NP Reflect Tapered Healing Abutment 3.5 Platform x 4.7 mmD x 3 mmH Inclusive® Healing Abutment 3.5 x 4.7 x 5 mm Inclusive® Tapered Implant 4.2 mmD x 8 mmL x 3.5 mmP Inclusive® Healing Abutment 3.5 x 3.5 x 5 mm

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)