Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)

K-Number: K230218 · 2023-04-25

ApplicantDental Direkt GmbH
Decision Date2023-04-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) is a medical device manufactured by Dental Direkt GmbH. It received FDA 510(k) clearance on 2023-04-25 under approval number K230218. 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 DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) is a medical device that received FDA 510(k) clearance on 2023-04-25. It is manufactured by Dental Direkt GmbH. The 510(k) number is K230218.

When was DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) approved by the FDA?

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) received FDA 510(k) clearance on 2023-04-25, under approval number K230218.

What company makes DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) is manufactured by Dental Direkt GmbH.

What is the FDA product code for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

The FDA product code for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) is NHA.

Related Clinical Trials

NCT03258580 Sociocultural & Biobehavioral Influences on Pain Expression and Assessment RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07529912 Detecting Beta-amyloid in the Retina TERMINATED NCT07545473 Retinal Hyperspectral Imaging in Neurodegenerative Diseases RECRUITING NCT03811821 Fecal Incontinence Treatment (FIT) Study COMPLETED NCT07504926 A Randomised Feasibility Study of CPAP in Large Airway Collapse NOT_YET_RECRUITING

Other Devices by Dental Direkt GmbH

K153490DD medical polymers K170885DD cubeX2 HS K183569DD cube ONE ML K193588DD Contrast K230410DD medical polymers (PMMA) K191111DD Solid Connect® CAD/CAM Abutments

View all 8 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.

↑