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FDA 510(k)

Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System

K-Number: K170044 · 2017-06-06

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2017-06-06
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2017-06-06 under approval number K170044. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System?

Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System is a medical device that received FDA 510(k) clearance on 2017-06-06. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K170044.

When was Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System approved by the FDA?

Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System received FDA 510(k) clearance on 2017-06-06, under approval number K170044.

What company makes Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System?

Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System is manufactured by Prismatik Dentalcraft, Inc..

What is the FDA product code for Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System?

The FDA product code for Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System is NHA.

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by Prismatik Dentalcraft, Inc.

K162537CAD/CAMouflage Milling Block K160979Inclusive Abutments K160425CAD/CAMouflage Milling Bock K153099INCLUSIVE TAPERED IMPLANT SYSTEM K191903BruxZir GT (Gum Tissue) Color K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV

View all 35 devices →

Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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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