BelleGlass Point 4

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K030646 ↗

FDA Product Code

EBD

Device Class

Class II

Regulation

21 CFR Part 872.3310

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Ez Connect Resin

  Class II

  FDA 510(k) K000357 Active Cleared 28 Apr 2000

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  FDA 510(k) K000346 Active Cleared 14 Apr 2000

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  Class II

  FDA 510(k) K992067 Active Cleared 27 Aug 1999

• Bioplant

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  FDA 510(k) K050984 Active Cleared 11 Aug 2005

• Belleglass Hp Opaque 2

  Class II

  FDA 510(k) K013375 Active Cleared 29 Oct 2001

• Optibond Solo Plus 3

  Class II

  FDA 510(k) K011908 Active Cleared 6 Sep 2001

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• What is BelleGlass Point 4 used for?

  BelleGlass Point 4 is a dual-cured indirect composite restorative material used within the belleGlass HP crown and bridge fabrication system. Dental laboratory technicians use this system to fabricate composite resin-based crowns and bridges.

• How is BelleGlass Point 4 supplied?

  The device is supplied as a coating, filling material, and resin with Class II special controls. It is manufactured by Kerr Dental Materials Center in Orange, California.

• What is the regulatory status of BelleGlass Point 4?

  BelleGlass Point 4 received FDA 510(k) clearance on May 6, 2003, with the K number K030646. It is classified as a Class II device with product code EBD and is substantially equivalent to other devices in this category.

• Is BelleGlass Point 4 a single-use or reusable product?

  The device information does not specify whether BelleGlass Point 4 is designed for single-use or multiple reuse. For proper usage instructions and disposal guidelines, please refer to the manufacturer's documentation or contact Kerr Dental Materials Center directly.