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FDA 510(k)

TopCEM Vigor SA Self-Adhesive Resin Cement

K-Number: K252785 · 2025-12-12

ApplicantRizhao Huge Biomaterials Company, Ltd.
Decision Date2025-12-12
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TopCEM Vigor SA Self-Adhesive Resin Cement is a medical device manufactured by Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2025-12-12 under approval number K252785. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TopCEM Vigor SA Self-Adhesive Resin Cement?

TopCEM Vigor SA Self-Adhesive Resin Cement is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K252785.

When was TopCEM Vigor SA Self-Adhesive Resin Cement approved by the FDA?

TopCEM Vigor SA Self-Adhesive Resin Cement received FDA 510(k) clearance on 2025-12-12, under approval number K252785.

What company makes TopCEM Vigor SA Self-Adhesive Resin Cement?

TopCEM Vigor SA Self-Adhesive Resin Cement is manufactured by Rizhao Huge Biomaterials Company, Ltd..

What is the FDA product code for TopCEM Vigor SA Self-Adhesive Resin Cement?

The FDA product code for TopCEM Vigor SA Self-Adhesive Resin Cement is EMA.

Related Clinical Trials

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Other Devices by Rizhao Huge Biomaterials Company, Ltd.

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Related Devices (Code: EMA)

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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.

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