PAGALIN 2

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

510(k) Number

K911675 ↗

FDA Product Code

EJS

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• V-Delta, Sf

  Class II

  FDA 510(k) K911537 Active Cleared 29 Apr 1991

• Solaro 4

  Class II

  FDA 510(k) K911544 Active Cleared 29 Apr 1991

• V-Deltabond

  Class II

  FDA 510(k) K911536 Active Cleared 29 Apr 1991

• V92

  Class II

  FDA 510(k) K911533 Active Cleared 29 Apr 1991

• Standard S1

  Class II

  FDA 510(k) K912303 Active Cleared 26 Jun 1991

• VS1B

  Class II

  FDA 510(k) K912299 Active Cleared 26 Jun 1991

See all devices from Metalor Dental USA Corp. →

• What is PAGALIN 2 used for in dental applications?

  PAGALIN 2 is a Class II dental alloy made of noble metal, intended for various dental applications. It is classified under product code EJS and received FDA 510(k) clearance on June 27, 1991, making it substantially equivalent to other devices in this category.

• Is PAGALIN 2 a single-use device or can it be reused?

  The device data does not specify whether PAGALIN 2 is designed for single-use or reuse. As a dental alloy, its usage would depend on the specific dental procedure and the clinician's judgment regarding sterilization and reuse protocols.

• What is the regulatory status of PAGALIN 2?

  PAGALIN 2 received FDA 510(k) clearance on June 27, 1991, with K number K911675. It is classified as a Class II device with special controls under regulation number 872.3060 and was reviewed by the Dental advisory committee.

• Who manufactures PAGALIN 2 and where is it produced?

  PAGALIN 2 is manufactured by Metalor Dental USA Corp., located at 457 Laurel Rd., Box 369, Rockville Centre, NY 11571, USA. The company has multiple registration numbers with the FDA, including 3003103749 and 3009300369.