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FDA 510(k)

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV

K-Number: K191222 · 2019-08-05

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2019-08-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2019-08-05 under approval number K191222. 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: Dentsply Implants Astra Tech Implant System EV?

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV is a medical device that received FDA 510(k) clearance on 2019-08-05. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K191222.

When was Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV approved by the FDA?

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV received FDA 510(k) clearance on 2019-08-05, under approval number K191222.

What company makes Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV?

Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV is manufactured by Prismatik Dentalcraft, Inc..

What is the FDA product code for Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV?

The FDA product code for Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV is NHA.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) PMID: 41620260 [Breast implants and cancer: Anaplastic large cell lymphoma in breast implants]. Annales de chirurgie plastique et esthetique (2026)

Other Devices by Prismatik Dentalcraft, Inc.

K162537CAD/CAMouflage Milling Block K160979Inclusive Abutments K160425CAD/CAMouflage Milling Bock K153099INCLUSIVE TAPERED IMPLANT SYSTEM K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System K191903BruxZir GT (Gum Tissue) Color

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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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