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FDA 510(k)

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm

K-Number: K171728 · 2017-09-28

ApplicantSterngold Dental, LLC
Decision Date2017-09-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is a medical device manufactured by Sterngold Dental, LLC. It received FDA 510(k) clearance on 2017-09-28 under approval number K171728. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm?

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is a medical device that received FDA 510(k) clearance on 2017-09-28. It is manufactured by Sterngold Dental, LLC. The 510(k) number is K171728.

When was MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm approved by the FDA?

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm received FDA 510(k) clearance on 2017-09-28, under approval number K171728.

What company makes MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm?

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is manufactured by Sterngold Dental, LLC.

What is the FDA product code for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm?

The FDA product code for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is DZE.

Related Clinical Trials

NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT07557836 Comparative Clinical Study of Implant Stability and Peri-implant Bone Loss in Two Implant Designs COMPLETED NCT02204618 Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study. COMPLETED NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED NCT07338864 A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults NOT_YET_RECRUITING

Other Devices by Sterngold Dental, LLC

K153173MOR Implant System

Related Devices (Code: DZE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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