Reverse Pull Adjustable Facemask
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162543 FDA 510(k)
- FDA Product Code
- DZB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5500 FDA 510(k)
- Regulation Number
- 872.5500 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Reverse Pull Adjustable Facemask is an Extraoral Orthodontic Headgear (DZB), designed to apply reverse traction forces to correct Class III malocclusion. Constructed from stainless steel, plastic, and foam pads, it is applied externally to the face to guide jaw alignment during orthodontic treatment.
Supplied as a reusable device under 21 CFR 872.5500, it is intended for clinical use in dental settings. The facemask requires proper adjustment and fitting by a trained orthodontist, with no specified sterility requirements beyond standard dental practice protocols. Authorised under FDA 510(k) clearance and MDR compliance, it adheres to Class II regulatory standards for orthodontic headgear.
Frequently asked questions
What is the primary purpose of the Reverse Pull Adjustable Facemask and how does it work?
The Reverse Pull Adjustable Facemask is designed to correct Class III malocclusion, a condition where the lower jaw protrudes beyond the upper jaw. It applies reverse traction forces externally to the face, guiding jaw alignment during orthodontic treatment. The device uses stainless steel, plastic, and foam pads to distribute pressure while being adjusted by a trained orthodontist.
Is this device single-use or reusable, and what cleaning or maintenance is required?
The Reverse Pull Adjustable Facemask is reusable and classified under 21 CFR 872.5500 for orthodontic headgear. Since it is not sterile by design, it must follow standard dental practice protocols for cleaning and maintenance to ensure hygiene and functionality between uses.
How is the device regulated, and what regulatory bodies have approved it?
The device holds FDA 510(k) clearance (K162543) and complies with MDR (Medical Device Regulation) standards. It is classified as Class II under the Dental advisory committee (DE) and is substantially equivalent to predicate devices, as confirmed by the FDA’s decision.
Who should fit and adjust this facemask, and what considerations should be taken during use?
The Reverse Pull Adjustable Facemask must be fitted and adjusted by a trained orthodontist due to its specialized design for correcting jaw alignment. Proper sizing and positioning are critical for effectiveness, and adjustments should follow clinical guidelines to avoid discomfort or misalignment.
What materials is the device made from, and how does this affect its durability?
The facemask is constructed from stainless steel, plastic, and foam pads, which provide structural integrity and comfort. Stainless steel ensures durability for repeated use, while the foam pads help distribute pressure evenly during orthodontic treatment. These materials are chosen for longevity and compatibility with clinical environments.
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: Reverse Pull Adjustable Face Mask - sawbros.com, PDF S001_K162543_Summary - Food and Drug Administration, Reverse Pull Adjustable Facemask (K162543) — FDA 510 (k) | Innolitics, Reverse Pull Adjustable Facemask 510 (k) FDA Premarket Notification ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162543 | Class II | Active |
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Manufacturer
- Manufacturer
- Sawbros Industries Pvt. Ltd.
- FDA Applicant
- Sawbros Industries Pvt., Ltd.
Sources (2)
- FDA 510(k) K162543 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026