Dr. Greensburg's Hybrid
by Always More Marketing, Inc.
510(k) K111680
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111680 | Date23 Dec 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LRK
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5570
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
A dental device classified as an anti-snoring appliance, the Dr. Greensburg’s Hybrid is designed to address obstructive sleep apnea by repositioning the jaw and tongue to maintain an open airway during sleep. It combines oral and mandibular components to provide adjustable support for patients with mild to moderate sleep-disordered breathing.
Supplied as a single-use or reusable device depending on the model, the Dr. Greensburg’s Hybrid is intended for use in dental offices under professional supervision. It is regulated under FDA 510(k) clearance (K111680) as a Class II device under regulation 872.5570, with no specific MRI safety restrictions noted. Sizes and configurations are referenced by the product codes listed in the submission, and sterility or cleaning instructions are not detailed in the regulatory data.
Other devices from Always More Marketing Inc
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Dr. Greensburg’s Hybrid and how does it work?
The Dr. Greensburg’s Hybrid is designed as an anti-snoring appliance to address obstructive sleep apnea by repositioning the jaw and tongue to keep the airway open during sleep. It combines oral and mandibular components to provide adjustable support, targeting patients with mild to moderate sleep-disordered breathing.
Is the Dr. Greensburg’s Hybrid intended for home use or must it be fitted and used under professional supervision?
The device is intended for use in dental offices under professional supervision, as indicated in the regulatory data. While it may be supplied as either single-use or reusable depending on the model, its application requires clinical oversight.
Are there different sizes or configurations available for the Dr. Greensburg’s Hybrid, and how are they identified?
Yes, the Dr. Greensburg’s Hybrid comes in multiple sizes and configurations, each referenced by specific product codes listed in the regulatory submission (e.g., LRK). These codes correspond to different models or adjustments for patient-specific use.
Can the Dr. Greensburg’s Hybrid be reused, or is it designed for single-use only?
The Dr. Greensburg’s Hybrid is available in both single-use and reusable models, depending on the specific variant. The regulatory data does not specify cleaning or sterility instructions, so reuse would depend on manufacturer guidelines for the chosen model.
What regulatory pathway was followed for the Dr. Greensburg’s Hybrid, and what does that mean for its use?
The device was cleared through the FDA’s 510(k) process (K111680) as a Class II medical device under regulation 872.5570, classified under dental anti-snoring appliances. This clearance indicates it meets FDA standards for safety and effectiveness, but its use remains subject to professional supervision as outlined in the regulatory submission.