Adherence M5 Multi-Cure Composite Cement System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K891463 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K914317 Active Cleared 26 Mar 1992

• Surgi Pak Ne and Cocoment Eugenal Free Paste Syst

  Class II

  FDA 510(k) K902817 Active Cleared 28 Aug 1990

• Porcelain Primer

  Class II

  FDA 510(k) K920534 Active Cleared 26 Mar 1992

• Cyrstalline L3 Multi-Use Hybrid Composite

  Class II

  FDA 510(k) K946307 Active Cleared 26 Jan 1995

• Crystalline C2 and Crystalline L3

  Class II

  FDA 510(k) K894890 Active Cleared 27 Oct 1989

• Granitec Z2, Zinc Phosphate Cement

  Class II

  FDA 510(k) K896649 Active Cleared 22 Feb 1990

See all devices from Confi-Dental Products Co. →

• What clinical purpose does the Adherence M5 Multi-Cure Composite Cement System serve?

  It is a composite cement system intended for dental procedures, providing a material that can bond restorations to tooth structure. Its classification under product code EBF and the advisory committee designation for dental indicates it is meant for routine dental cementation tasks.

• How was the Adherence M5 Multi-Cure Composite Cement System cleared for market?

  The device received FDA 510(k) clearance (K891463) on May 19, 1989, as substantially equivalent to a predicate device. This traditional clearance route means the FDA determined it has the same safety and effectiveness profile as an already marketed product.

• Is the Adherence M5 Multi-Cure Composite Cement System supplied as a sterile product?

  The provided data does not specify sterility status or packaging details. Because it is a dental cement system, manufacturers typically supply it in a form ready for clinical use, but the exact sterility claim cannot be confirmed from the available information.

• What regulatory classification applies to the Adherence M5 Multi-Cure Composite Cement System?

  The device is classified under product code EBF and falls under the dental advisory committee (DE). This classification reflects its intended use as a dental material and aligns with the FDA’s product coding system for composite cements.