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)

NobelProcera Zirconia Implant Bridge

K-Number: K202452 · 2020-12-03

ApplicantNobel Biocare AB
Decision Date2020-12-03
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NobelProcera Zirconia Implant Bridge is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2020-12-03 under approval number K202452. 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 NobelProcera Zirconia Implant Bridge?

NobelProcera Zirconia Implant Bridge is a medical device that received FDA 510(k) clearance on 2020-12-03. It is manufactured by Nobel Biocare AB. The 510(k) number is K202452.

When was NobelProcera Zirconia Implant Bridge approved by the FDA?

NobelProcera Zirconia Implant Bridge received FDA 510(k) clearance on 2020-12-03, under approval number K202452.

What company makes NobelProcera Zirconia Implant Bridge?

NobelProcera Zirconia Implant Bridge is manufactured by Nobel Biocare AB.

What is the FDA product code for NobelProcera Zirconia Implant Bridge?

The FDA product code for NobelProcera Zirconia Implant Bridge is NHA.

Related Clinical Trials

NCT06012071 Two-piece Zirconia Implants With Two Various Platforms RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT01974362 Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior RECRUITING NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING NCT07522671 Clinical Performance of 3D-Printed Resin and Zirconia Implant Restorations RECRUITING

Other Devices by Nobel Biocare AB

K162043NobelProcera HT ML FCZ Bridge K161435Temporary Snap Abutment K161634IPS CaseDesigner K160158NobelProcera HT ML FCZ Implant Bridge and Framework K153534NobelProcera HT ML Full Contour Zirconia Crown K160119NobelSpeedy Groovy

View all 39 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.

↑