FDA 510(k)

NobelProcera HT ML FCZ Implant Bridge and Framework

K-Number: K160158 · 2016-07-25

Decision Date2016-07-25

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

NobelProcera HT ML FCZ Implant Bridge and Framework is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2016-07-25 under approval number K160158. 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 HT ML FCZ Implant Bridge and Framework?

NobelProcera HT ML FCZ Implant Bridge and Framework is a medical device that received FDA 510(k) clearance on 2016-07-25. It is manufactured by Nobel Biocare AB. The 510(k) number is K160158.

When was NobelProcera HT ML FCZ Implant Bridge and Framework approved by the FDA?

NobelProcera HT ML FCZ Implant Bridge and Framework received FDA 510(k) clearance on 2016-07-25, under approval number K160158.

What company makes NobelProcera HT ML FCZ Implant Bridge and Framework?

NobelProcera HT ML FCZ Implant Bridge and Framework is manufactured by Nobel Biocare AB.

What is the FDA product code for NobelProcera HT ML FCZ Implant Bridge and Framework?

The FDA product code for NobelProcera HT ML FCZ Implant Bridge and Framework is NHA.

Related Clinical Trials

NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT07563803 The restor3d Outcomes Registry NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39744726 Regulatory gaps in India's medical device framework: The case of Johnson and Johnson's faulty hip implants. World journal of orthopedics (2024)

Other Devices by Nobel Biocare AB

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Related Devices (Code: NHA)

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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.