Inclusive Abutments
K-Number: K160979 · 2016-11-04
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2016-11-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Inclusive Abutments is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2016-11-04 under approval number K160979. 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 Abutments?
Inclusive Abutments is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K160979.
When was Inclusive Abutments approved by the FDA?
Inclusive Abutments received FDA 510(k) clearance on 2016-11-04, under approval number K160979.
What company makes Inclusive Abutments?
Inclusive Abutments is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for Inclusive Abutments?
The FDA product code for Inclusive Abutments is NHA.
Other Devices by Prismatik Dentalcraft, Inc.
K162537CAD/CAMouflage Milling Block
K160425CAD/CAMouflage Milling Bock
K153099INCLUSIVE TAPERED IMPLANT SYSTEM
K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
K191903BruxZir GT (Gum Tissue) Color
K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
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.