Identifiers
- 510(k) Number
- K161684 FDA 510(k)
- FDA Product Code
- DYH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3750 FDA 510(k)
- Regulation Number
- 872.3750 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Quantum LB is an adhesive, bracket and tooth conditioner, resin device intended for use as a light cure orthodontic adhesive. It is classified as a Class II medical device under the dental specialty.
The device was cleared via the FDA 510(k) pathway under K number K161684 on October 6, 2016, and is manufactured by Reliance Orthodontic Products, Inc. It is supplied as a resin-based adhesive for orthodontic bonding procedures.
Frequently asked questions
What is Quantum LB used for?
Quantum LB is an adhesive, bracket and tooth conditioner, resin device intended for use as a light cure orthodontic adhesive in orthodontic bonding procedures.
How is Quantum LB supplied and what is its form?
Quantum LB is supplied as a resin-based adhesive for orthodontic bonding procedures, meaning it is provided in a resin form designed to be cured with light during clinical use.
What regulatory pathway was used for Quantum LB and when was it cleared?
Quantum LB was cleared via the FDA 510(k) pathway under K number K161684 on October 6, 2016, based on a determination of substantial equivalence to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Quantum LB (K161684) — FDA 510(k) | Innolitics, Quantum LB — FDA 510 (k) K161684 | MedTracker, Bonding Adhesives | Aligner Solutions | Reliance Orthodontic Products, Reliance Orthodontic Products, Inc. FDA 510(k) Products 2021, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161684 | Class II | Active |
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Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA 510(k) K161684 24 fields · synced Sep 21, 2026