Gluma One Bond
by Heraeus Kulzer, Inc. 510(k)
Active
510(k) K974390
Overview
Gluma One Bond is an agent for tooth bonding resin, classified as a dental device. It is a one-bottle adhesive designed to bond resinous restorative materials to dental hard tissue.
The product is a light-curing monomer mixture dissolved in acetone, applied to enamel and dentin after conditioning with phosphoric acid, prior to co-polymerization with the restorative material. It is supplied as a single-use device and has received FDA 510(k) clearance under K974390.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974390 | Date4 Feb 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KLE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Heraeus Kulzer, Inc.
Questions
What is Gluma One Bond used for in dental procedures?
Gluma One Bond is a one-bottle adhesive designed to bond resinous restorative materials to dental hard tissue, such as enamel and dentin. It is applied after conditioning the tooth surface with phosphoric acid and before copolymerization with the restorative material, ensuring a strong bond for fillings or other restorative treatments.
Is Gluma One Bond intended for single-use or can it be reused?
Gluma One Bond is explicitly supplied as a single-use device. This means each bottle is meant for one application only, ensuring sterility and preventing cross-contamination between patients.
How is Gluma One Bond supplied, and what should I consider when storing it?
Gluma One Bond is supplied as a single-use bottle containing a light-curing monomer mixture dissolved in acetone. Since it is a single-use product, storage should follow standard guidelines for dental adhesives—keep it in a cool, dry place, away from direct sunlight, and ensure the bottle remains tightly sealed until use.
What regulatory pathway was followed for FDA clearance of Gluma One Bond?
Gluma One Bond received FDA clearance through a 510(k) submission, classified as substantially equivalent under the Traditional clearance type. The submission was reviewed by the Dental (DE) Advisory Committee and filed under product code KLE, with a decision date of February 4, 1998.