Pulp Canal Sealer EWT

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

510(k) Number

K945244 ↗

FDA Product Code

EMA

Device Class

Class II

Regulation

21 CFR Part 872.3275

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Prodigy 4

  Class II

  FDA 510(k) K990898 Active Cleared 6 Apr 1999

• Kerr Gel Etchant

  Class II

  FDA 510(k) K000954 Active Cleared 28 Apr 2000

• Sealapex 4

  Class II

  FDA 510(k) K010940 Active Cleared 20 Jun 2001

• Point 4 Flowable

  Class II

  FDA 510(k) K012321 Active Cleared 27 Aug 2001

• Temp-Bond Ne 2

  Class II

  FDA 510(k) K003658 Active Cleared 4 Jan 2001

• Extrude

  Class II

  FDA 510(k) K940379 Active Cleared 22 Mar 1994

See all devices from Sybron Dental Specialties, Inc. →

• What is the primary purpose of the Pulp Canal Sealer EWT in endodontic treatment?

  The Pulp Canal Sealer EWT is designed specifically to fill and seal the root canal system during endodontic therapy. Its zinc oxide-eugenol-based formula helps prevent microbial leakage, which is critical for ensuring the long-term success of root canal treatment by maintaining a sterile and sealed environment within the canal.

• How is the Pulp Canal Sealer EWT supplied, and what makes it unique compared to other root canal sealers?

  The Pulp Canal Sealer EWT comes as a powder-liquid system, which requires mixing before use. What sets it apart is its extended working time of over six hours, allowing clinicians more flexibility and precision when placing and adapting the material within the root canal system.

• Is the Pulp Canal Sealer EWT intended for single-use or can it be reused?

  The Pulp Canal Sealer EWT is explicitly intended for single-use in clinical settings. This ensures sterility and performance consistency, as reusing dental materials can compromise their effectiveness and introduce contamination risks.

• What storage instructions should be followed to maintain the product’s sterility and performance?

  The product must be stored according to the manufacturer’s guidelines to preserve sterility and performance. While the exact storage conditions aren’t detailed here, typical dental cements like this require protection from moisture, extreme temperatures, and direct light to maintain their integrity until use.

• What is the regulatory pathway for this device, and how does it classify under FDA regulations?

  The Pulp Canal Sealer EWT follows the FDA’s 510(k) clearance pathway, classified as a Class II medical device. It was determined to be *substantially equivalent* to a predicate device, meaning it meets the same performance standards and regulatory requirements as previously approved root canal sealers in this category.