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)

Straumann CI RD Ceramic Healing Caps

K-Number: K190654 · 2019-06-28

ApplicantInstitut Straumann AG
Decision Date2019-06-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann CI RD Ceramic Healing Caps is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2019-06-28 under approval number K190654. 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 Straumann CI RD Ceramic Healing Caps?

Straumann CI RD Ceramic Healing Caps is a medical device that received FDA 510(k) clearance on 2019-06-28. It is manufactured by Institut Straumann AG. The 510(k) number is K190654.

When was Straumann CI RD Ceramic Healing Caps approved by the FDA?

Straumann CI RD Ceramic Healing Caps received FDA 510(k) clearance on 2019-06-28, under approval number K190654.

What company makes Straumann CI RD Ceramic Healing Caps?

Straumann CI RD Ceramic Healing Caps is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann CI RD Ceramic Healing Caps?

The FDA product code for Straumann CI RD Ceramic Healing Caps is NHA.

Related Clinical Trials

NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT06086873 Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA RECRUITING NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING

Other Devices by Institut Straumann AG

K161677Straumann Sterile Healing Solution K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, K153758Straumann Bone Level Tapered Implants K171773Straumann n!ce Glass Ceramic A14 Blocks K173410n!ce for Planmill K162848Straumann CARES Golden Ti/TiN Abutments

View all 56 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.

↑