Trend Set 2 Plus

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

510(k) Number

K936070 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Confi-Dental Products Co. →

• Is the Trend Set 2 Plus impression material reusable or single-use, and how does this affect its use in a dental office?

  The Trend Set 2 Plus is explicitly described as a reusable impression material, meaning it can be used multiple times after proper cleaning and sterilization between patients. This makes it cost-effective for dental offices, as it eliminates the need to purchase single-use materials for each impression. However, the manufacturer does not specify sterilization methods or cycles, so offices must follow established dental protocols to ensure safety and accuracy between uses.

• What sizes or models of the Trend Set 2 Plus are available, and how do I determine which one to use for my patient?

  The provided data does not list specific sizes or model variations of the Trend Set 2 Plus. However, it is classified under product code ELW (impression materials) and is associated with a wide range of FEI numbers (e.g., 3003762341, 3013020540), which may correspond to different packaging or batch identifiers rather than distinct sizes. Clinicians should consult the manufacturer’s packaging or technical documentation for details on available sizes or models, as these are not specified in the regulatory submission.

• Does the Trend Set 2 Plus require any special storage conditions, and if so, what are they?

  The data does not provide explicit storage instructions for the Trend Set 2 Plus. However, as a reusable dental impression material, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity. Offices should follow the manufacturer’s guidelines (if available) or general dental material storage practices to prevent degradation, as no specific requirements are mentioned in the regulatory filing.

• What is the regulatory pathway for the Trend Set 2 Plus, and how does this affect its use in clinical practice?

  The Trend Set 2 Plus received FDA 510(k) clearance under the product code ELW, classified as Class II, with a regulatory number of 872.3660. This means it was determined to be substantially equivalent to a legally marketed predicate device and is subject to general controls plus special controls for dental impression materials. Clinicians can use it with confidence that it meets FDA standards for safety and effectiveness, though they should always follow the manufacturer’s instructions for proper handling and application.