TempoCem NE (Multiple)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K970774 ↗

FDA Product Code

EMA

Device Class

Class II

Regulation

21 CFR Part 872.3275

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K970683 Active Cleared 15 Jul 1997

• Foremost Lite Cure Pit & Fissure Sealant

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  FDA 510(k) K845034 Active Cleared 18 Mar 1985

• Ionosit Base Liner

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• Foremost Dentin Adhesive

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See all devices from Foremost Dental Mfg., Inc. →

• What is TempoCem NE (Multiple) used for?

  TempoCem NE (Multiple) is a dental luting cement designed specifically for the temporary cementation of provisional crowns and bridges. It creates a chemical adhesive bond to stabilize restorations until they can be permanently cemented. This makes it ideal for short-term clinical use in dental restorative procedures where immediate stability is required.

• How is TempoCem NE (Multiple) supplied, and is it reusable?

  TempoCem NE (Multiple) is supplied as a multi-unit dental luting agent intended for single-use in dental offices. It is not intended for reuse or sterilization, ensuring patient safety and maintaining product efficacy for each application.

• Is there any specific storage guidance for TempoCem NE (Multiple)?

  The provided data does not include explicit storage instructions for TempoCem NE (Multiple). However, as a dental luting cement, it should generally be stored in a cool, dry place, away from direct sunlight, to preserve its integrity until use.

• What regulatory pathway does TempoCem NE (Multiple) follow?

  TempoCem NE (Multiple) is cleared under the FDA’s 510(k) pathway, specifically Traditional 510(k) review, and is classified as a Class II dental device. It was cleared in 1997 under the product code EMA, with the 510(k) number K970774, and is substantially equivalent to prior devices in its category.