Respironics Custom I Oral Appliance
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033822 FDA 510(k)
- FDA Product Code
- LRK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Respironics Custom I Oral Appliance is a removable mandibular repositioning dental device designed to address snoring and obstructive sleep apnea. It falls under the category of anti-snoring devices and is classified as a Class II medical device. The appliance works by repositioning the mandible to maintain an open airway during sleep, thereby reducing or eliminating obstructive breathing events.
This device is supplied as a custom-fitted, single-use dental appliance intended for prescription use by a dentist. It is not sterile at the time of supply but is sterilized via boiling during the fitting process. The appliance is non-reusable and must be replaced as needed. No specific MRI safety information is provided, and the device is available in multiple reference codes as listed in the regulatory submission. The device holds an FDA 510(k) clearance under the classification of dental devices.
Frequently asked questions
What is the Respironics Custom I Oral Appliance used for?
The Respironics Custom I Oral Appliance is a removable mandibular repositioning dental device designed to address snoring and obstructive sleep apnea. It works by repositioning the jaw (mandible) to maintain an open airway during sleep, thereby reducing or eliminating obstructive breathing events. This helps improve sleep quality and reduce daytime fatigue associated with sleep-disordered breathing.
How is the Respironics Custom I Oral Appliance supplied and prepared for use?
The device is supplied as a custom-fitted, single-use dental appliance intended for prescription use by a dentist. It is not sterile at the time of supply but undergoes sterilization through boiling during the fitting process. This ensures it is safe for use after customization. The appliance is non-reusable and must be replaced as needed, as it is designed for individual patient use.
Is the Respironics Custom I Oral Appliance reusable?
No, the Respironics Custom I Oral Appliance is designed for single-use only. Since it is custom-fitted to a patient’s dental structure, it cannot be reused for another individual. After use, it should be replaced with a new appliance as needed to maintain proper function and hygiene.
What reference codes or models are available for the Respironics Custom I Oral Appliance?
The Respironics Custom I Oral Appliance is available in multiple reference codes, including but not limited to: 2082148, 3016674860, 3006098230, 3031288631, and many others. These codes correspond to different configurations or variations of the device, all of which fall under the same FDA-cleared classification. Your dentist or supplier can provide the specific reference code based on your needs.
How should the Respironics Custom I Oral Appliance be stored?
While the device is not sterile at the time of supply, it is sterilized via boiling during the fitting process, which ensures it is safe for use immediately after customization. After use, the appliance should be stored in a clean, dry place, away from direct sunlight or extreme temperatures. Since it is a single-use device, proper storage is primarily relevant for any unused or replacement appliances. Always follow your dentist’s instructions for handling and storage to maintain its integrity.
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: RESPIRONICS CUSTOM I ORAL APPLIANCE (K033822) — FDA 510 (k) - Innolitics, fda.innolitics.com, PDF K033822 - Respironics Custom I Oral Appliance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033822 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K033822 24 fields · synced Oct 1, 2026