Gluma Comfort Bond

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992985 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Heraeus Kulzer, Inc. →

• What is the primary use of Gluma Comfort Bond?

  Gluma Comfort Bond is a one-bottle, light-cured dental adhesive system designed to function as a priming and bonding agent for restorative dentistry.

• How is this dental adhesive applied?

  The clinician applies the agent to conditioned, moist tooth surfaces using consecutive strokes, followed by air-drying and light curing for 20 seconds.

• What is the regulatory status of this device?

  This device is subject to FDA 510(k) authorization, which indicates it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.