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Dentastic One-Step

FDA 510(k)

Class II (US FDA 510(k))

510(k) K953301

by Pulpdent Corporation

Identifiers

510(k) Number
K953301 FDA 510(k)
FDA Product Code
EMA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3275 FDA 510(k)
Regulation Number
872.3275 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dentastic One-Step is a dental adhesive cement designed for bonding to multiple substrates, including dentin, enamel, porcelain, metal, and resins. Classified as a dental cement under FDA product code EMA, it is intended for use in restorative and adhesive dentistry procedures, providing a single-component, one-step application for wet bonding.

This device is supplied as a single-use adhesive system and is regulated under FDA 510(k) clearance (K953301) as a Class II medical device. It is intended for use in clinical settings where precise bonding is required, such as in dental restorations. The product is not described as MRI-safe or reusable, and no sterility specifications are provided in the available data.

Frequently asked questions

What types of dental materials can the Dentastic One-Step adhesive cement bond to, and why is this important for clinical use?

The Dentastic One-Step adhesive cement is designed to bond to multiple substrates, including dentin, enamel, porcelain, metal, and resins. This versatility is important for clinical use because it allows dentists to apply a single adhesive system across various restorative materials, simplifying workflow and reducing the need for multiple bonding agents. This is particularly useful in procedures requiring composite restorations, crowns, or bridges where different substrates may be present.

Is the Dentastic One-Step adhesive system intended for single-use only, and how does this affect its clinical application?

Yes, the Dentastic One-Step adhesive system is supplied as a single-use adhesive system. This design ensures sterility and consistency for each patient, reducing the risk of cross-contamination and ensuring optimal bonding performance. Clinicians should use a fresh application for each patient to maintain safety and efficacy, as reuse is not recommended.

What regulatory pathway was followed for the FDA clearance of the Dentastic One-Step, and what does this mean for its clinical use?

The Dentastic One-Step received FDA clearance through a 510(k) submission (K953301), classified as a Class II medical device under the Dental specialty and product code EMA. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for dental adhesive cements. Clinicians can rely on this clearance as evidence of its regulatory review for use in restorative and adhesive dentistry.

Are there different sizes or models of the Dentastic One-Step adhesive system, and if so, how might this affect my purchasing decision?

The provided data lists multiple FEI numbers (e.g., 3012441963, 3038718579) and registration numbers, which typically correspond to different lot or variant identifiers rather than distinct product sizes or models. However, these identifiers suggest the system may be available in various packaging configurations or batch sizes. If you require specific quantities or formulations, confirm with Pulpdent Corporation whether these variations align with your clinical needs, such as practice size or patient volume.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K953301 FDA 510(k) - DENTASTIC ONE-STEP | Pulpdent Corp., DenTASTIC™ UNO™ - PULPDENT, DENTASTIC ONE-STEP 510 (k) K953301 - FDA.report, PDF K953301 - Dentastic One-step, DENTASTIC ONE-STEP (K953301) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K953301 24 fields · synced Sep 20, 2026