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)

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)

K-Number: K172761 · 2017-11-17

ApplicantShanghai New Century Dental Materials Co., Ltd.
Decision Date2017-11-17
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is a medical device manufactured by Shanghai New Century Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2017-11-17 under approval number K172761. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is a medical device that received FDA 510(k) clearance on 2017-11-17. It is manufactured by Shanghai New Century Dental Materials Co., Ltd.. The 510(k) number is K172761.

When was New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) approved by the FDA?

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) received FDA 510(k) clearance on 2017-11-17, under approval number K172761.

What company makes New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is manufactured by Shanghai New Century Dental Materials Co., Ltd..

What is the FDA product code for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

The FDA product code for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is EIH.

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT06012071 Two-piece Zirconia Implants With Two Various Platforms RECRUITING 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 NCT07521501 Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design NOT_YET_RECRUITING

Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160203ADAMANT ZIRCONIA DISCAdamant Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, 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.

↑