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Found 223 results
510(k) Data Aggregation
(92 days)
77043
Re: K252976
Trade/Device Name: Park Dental Nylon MAD
Regulation Number: 21 CFR 872.5570
Anti-Snoring & Device, Jaw Repositioning
Device Classification: Class II
Regulation Number: 872.5570
Same as reference |
| Device Class | Class II | Class II | Class II | Same |
| Classification | 21 CFR 872.5570
| 21 CFR 872.5570 | 21 CFR 872.5570 | Same |
| Rx | Rx only | Rx only | Rx only | Same |
| Anatomical
The Park Dental Nylon MAD is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The Park Dental Nylon Mandibular Advancement Device (MAD) is a custom-made, removable oral appliance consisting of two intraoral trays connected by an adjustable interlocking rigid rod. It is intended for use in patients diagnosed with Obstructive Sleep Apnea (OSA) and functions by advancing the lower jaw (mandible) during sleep to increase the pharyngeal airway space. This advancement reduces airway obstruction, minimizes snoring, and promotes improved sleep quality and reduced jaw tension.
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(135 days)
Model 100 Brachytherapy Source (K090321) | |
| Classification | 21 CFR § 892.5730, Class II | 21 CFR 872.5570
OncoPatch is indicated for the surface treatment of localized tumors. It is designed to deliver radiation therapy for the treatment of superficial lesions. It can be used either as primary treatment or as treatment for residual disease after excision of primary or recurrent tumors.
The OncoPatch device is engineered for the surface treatment of skin cancers, such as basal and squamous cell carcinoma, as well as for other skin conditions, including keloids. Using yttrium-90 (Y-90) as the radioactive source, this device delivers low-energy beta radiation directly to the skin surface, targeting cancerous or abnormal tissue while sparing underlying healthy tissue. The OncoPatch device makes use of radioactive patches constructed from thin, polymer-coated foils containing Y-90. These foils are adhered to the underside of a plastic or metal composite shield, which ensures safety for both the patient and healthcare providers during treatment. The patch and shield are coupled with an applicator. The applicator uses collimators with predetermined shapes and sizes that assume a flat patient geometry. The OncoPatch is secured temporarily to the patient surface for single or multiple treatment fractions, typically with short (< 60 min) treatment durations.
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(2 days)
California 92108
Re: K253868
Trade/Device Name: QuietLab Pro
Regulation Number: 21 CFR 872.5570
| Common Name | QuietLab Pro |
| Classification Name | Device, Anti-Snoring |
| Regulation Number | 872.5570
Intended as an aid in the reduction of snoring for adults at least 18 years old.
The QuietLab Pro Anti-Snoring Mouthpiece is a reusable, over-the-counter oral appliance intended to reduce or eliminate snoring by gently repositioning the lower jaw to maintain an open upper airway during sleep. The device achieves this effect through a precision-adjustable mandibular advancement mechanism that minimizes airway collapse and reduces tissue vibration—the primary cause of snoring.
Scientific Basis and Mechanism of Action:
Snoring typically occurs when the muscles around the throat relax during sleep—especially during REM—causing a partial collapse of the airway. As air moves through this narrowed passage, it vibrates the soft tissues, producing the characteristic sound of snoring. The QuietLab Pro addresses this by:
- Advancing the lower jaw (mandible) slightly forward using a precision-fit tray and hinge system.
- Increasing pharyngeal space to prevent airway collapse.
- Promoting steady airflow and reducing soft tissue vibration during sleep.
Device Design and Key Performance Characteristics:
The QuietLab Pro is comprised of three primary components, designed for comfort, adjustability, and durability:
1. Central Part - Structural Component
- Thermoplastic Polyurethane for flexible hinge zones.
- Provides structural support, maintains upper/lower tray alignment, and enables lateral jaw movement during sleep.
2. Central Part – Hard Inserts & Attachment Pins (4-Pin Diamond-Shaped Sliding Mechanism)
- Made of Polycarbonate (PC) for rigidity
- Offers incremental, repeatable adjustment to tailor the mandibular position to the user's anatomy.
- Prevents unintentional shifting during use, improving comfort and treatment consistency.
3. Upper and Lower Trays (Anatomical Trays)
- Fabricated from Thermoplastic Elastomer
- Anatomically contoured to fit over dental arches without molding.
- The lower tray allows for up to 9 mm of mandibular advancement via a 25-position micro-adjustment system.
Material Composition:
All components are made of biocompatible, medical-grade materials tested for prolonged mucosal contact (per ISO 10993-1):
- PC (Polycarbonate) – Provides strength and stability.
- TPU (Thermoplastic Polyurethane) – Allows for flexibility at hinge and contact points.
- TPE (Thermoplastic Elastomer) – Ensures soft tissue compatibility and user comfort.
The device is manufactured in an ISO-certified facility under strict quality controls and is compliant with RoHS material safety standards.
The carrying-case material is indirect patient contact only.
Physical Properties:
- Non-sterile, reusable device intended for single-patient use.
- Designed for home use during sleep.
- Accommodates diverse dental anatomies through flexible materials and an Adaptive Fit system.
- Lightweight, with integrated grooves to promote airflow and minimize saliva buildup.
Function and Adjustability:
- Upper Tray: Provides upper jaw stabilization.
- Lower Tray: Delivers adjustable mandibular advancement.
- Adjustment Range: Up to 9 mm total advancement with fine control.
- Custom Fit: No boiling or molding required; adjustment is tool-free and user-controlled.
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(138 days)
Connecticut 06484
Re: K252161
Trade/Device Name: Hushd Avera
Regulation Number: 21 CFR 872.5570
for snoring
Classification Name: Device Anti-Snoring
Classification Regulation: 21 CFR 872.5570
Hybrid (K111680) REFERENCE PREDICATE** | Comments |
|---|---|---|---|
| Regulation | 21 CFR 872.5570
| 21 CFR 872.5570 | 21 CFR 872.5570 | Same |
| Class | Class II | Class II | Class II | Same |
|
The Hushd Avera device is intended to reduce or alleviate snoring.
The Hushd Avera device is a removable intraoral non-patient specific device used for treating snoring. The device consists of multiple trays that fit over the upper and lower teeth. When the upper and lower tray engages, the device functions as a mandibular repositioner holding the mandible forward during sleep thus preventing the tongue and soft tissues of the throat from collapsing into the airway.
The Hushd Avera device is a "Boil and Bite" device where both the upper and lower trays are constructed out of moldable soft ethylene vinyl acetate (EVA) material with rigid polypropylene (PP) outer shells.
Hushd Avera consists of one upper and two lower trays. Each upper tray contains a trapezoidal block on each side of the posterior to mate with the lower tray. An identification mark is placed on the blocks. The blocks and the outer shell of the upper tray are molded in one piece.
Each lower tray contains a vertical dorsal fin on each side of the posterior to serve as mating mechanism. The fins are triangular shaped at approximately 12.0mm(H) x 12.0mm(W) x 2.5mm(D). The mating surface of the fins are flat to ensure stable positioning of the upper and lower trays against each other. An identification mark is placed on the dorsal fins. The dorsal fins and the outer shell of the lower tray are molded in one piece.
There are no additional clip-on mechanisms connecting the upper and lower trays.
Relative to the upper tray (U), the first lower tray (L1) is positioned 1.0mm forward from an edge-to-edge position, while the upper tray (U) and the second lower tray (L2) have an additional 2.0mm protrusion. The user can select between the two positions as needed.
Therefore, the maximum protrusion is +3mm from edge to edge while using L2.
There are no variants for this device and it is available only in one configuration.
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(87 days)
, Texas 75701
Re: K252525
Trade/Device Name: AIO Breathe
Regulation Number: 21 CFR 872.5570
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. (21 CFR § 872.5570
Reference (K234089)DNA Appliance | Comparison Summary |
|---|---|---|---|---|
| Regulation | 21 CFR 872.5570
| 21 CFR 872.5570 | 21 CFR 872.5570 | Identical |
| Product Code | LRK, LQZ | LRK, LQZ | LRK, LQZ |
The AIO Breathe is intended to reduce snoring and to treat mild and moderate obstructive sleep apnea in children 6-17 years of age who are diagnosed with snoring and/or mild or moderate obstructive sleep apnea.
AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the teeth. The device is manufactured at AIOMEGA facilities using additive manufacturing with Stereolithography (SLA) 3D printing technology that builds the device from biocompatible resins. The customized trays are fabricated based on intraoral scans provided by the dentist and the dentist's prescription.
AIO Breathe features right and left protrusive flanges on the buccal sides of the upper tray. These flanges engage with corresponding right and left vertical flanges featured on the buccal sides of the lower tray. This engagement repositions the jaw to reflect the dentist's prescribed anterior mandibular advancement.
Additionally, mandibular plateaus, as prescribed by the dentist, featured on the right, and left occlusal cranial surfaces of lower tray, guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw (jaw is not fixed in a single position) and work together to maintain advancement in open and closed mouth positions. This design feature allows more room and creates traction for the tongue to migrate forward. The resulting mechanical protrusion increases the patient's pharyngeal space, improving their ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.
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(68 days)
, Texas 75057
Re: K252698
Trade/Device Name: NightGuard Aire Max
Regulation Number: 21 CFR 872.5570
Name:** Intraoral Devices for Snoring and/ or Obstructive Sleep Apnea
Regulation Number: 21 CFR 872.5570
Manufacturer | Nightguard Express, LLC | EMA Sleep Incorporated | N/A |
| Regulatory Classification | 21 CFR 872.5570
| 21 CFR 872.5570 | Same |
| Classification | II | II | Same |
| Product Code | LRK | LRK | Same |
|
Both devices are classified under 21 CFR 872.5570, Class II, with the same product code (LRK), and share
The NightGuard Aire Max is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The NightGuard Aire Max is a custom made intraoral appliance intended to treat mild to moderate Obstructive Sleep Apnea (OSA) and habitual snoring. The device's primary function is mandibular advancement, which repositions the lower jaw forward during sleep. This forward positioning helps reduce airway obstruction, promoting improved airflow and alleviating symptoms associated with snoring and Obstructive Sleep Apnea (OSA). The device comprises two custom made trays, each featuring two embedded button hooks on each side, and a pair of elastic bands. The hooks are positioned at a distance of 20mm apart from the upper tray hook to the bottom tray hook. These hooks serve as secure attachment points for the elastic bands, which serve to keep the trays in place. The bands are available in four different sizes (20mm, 19mm, 18mm, and 17mm) ensuring a functional, customizable fit for each patient. The upper and lower trays each support a structural element, and the structural elements together maintain an open airway. In particular, the lower tray features an anterior platform with a bump elevation located at a position corresponding to a patient's central incisors. This bump serves as a specific point of contact to maintain an open airflow space, supporting the functionality of the anterior platform. The upper tray includes a flat plane at a position corresponding to the patient's central incisors, which works in conjunction with the bump elevation on the lower tray to facilitate airflow during use. The upper and lower trays are manufactured using one of three FDA-cleared, biocompatible materials: Dental LT Comfort Resin, KeySplint Hard Resin, or KeySplint Soft Resin, each of which is suitable for long-term contact with oral tissues.
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(29 days)
K253355**
Trade/Device Name: Difiney Advanced Anti Snoring Device 4.0
Regulation Number: 21 CFR 872.5570
obstructive sleep apnea |
| Classification Name | Device, Anti-Snoring |
| Regulation Number | 872.5570
The Difiney Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.
The Difiney Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring.
The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.
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(135 days)
Connecticut 06484
Re: K251784
Trade/Device Name: Hushd Pro Z-Link
Regulation Number: 21 CFR 872.5570
sleep apnea
Classification Name: Device Anti-Snoring
Classification Regulation: 21 CFR 872.5570
Device: Panthera Anti-Snoring device (K143244) | Comments |
|---|---|---|---|---|
| Regulation | 21 CFR 872.5570
| 21 CFR 872.5570 | 21 CFR 872.5570 | Same |
| Class | Class II | Class II | Class II | Same |
| Product
The Hushd Pro Z-Link device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The Hushd Pro Z-Link device series are removable intraoral patient-specific device intended for the treatment of snoring and mild to moderate obstructive sleep apnea. The device consists of custom-made maxillary and mandibular splints that fit over the upper and lower teeth, and are connected via a pair of detachable rigid connectors. When linked, the splints function as a mandibular repositioner by holding the lower jaw in a forward position during sleep, thereby preventing the tongue and soft tissues from collapsing into the airway.
Each device consists of one maxillary and one mandibular splint, designed and manufactured using 3D printing technology. The splints incorporate a pair of integrated studs that are located around the canine area for the maxillary splint and around the first molar area for the mandibular splint. These studs interface with slots on the detachable connectors to securely link the two splints together. This configuration permits the mandible to advance from the baseline position, offering improved patient comfort.
Titration is achieved by replacing the connectors with another pair of a different size. The connectors are available in 1.0 mm incremental lengths, allowing progressive mandibular advancement according to patient tolerance and clinical need. A standard set includes six pairs of connectors, ranging from -1 mm to +5 mm protrusion, while an extended set ranging from +6 mm to +10 mm is available upon request, providing a maximum mandibular protrusion of 10 mm.
The connectors are not elastic and do not contain adjustment mechanisms such as pistons, screws, straps, or repositioning elastics. The rigid connectors are manufactured with medical grade nylon PA12 using commercial injection molding process and are marked for easy identification.
The splints of this device are manufactured using selective laser sintering (SLS) 3D printing with EOS PA2200 polyamide (nylon) PA12 material. This material offers excellent mechanical properties, long-term stability, and has a history of safe use in oral medical devices. The manufacturing process includes mechanical or chemical polishing, cleaning, and rigorous quality control prior to packaging.
The Hushd Pro Z-Link is available for prescription only and designed based on optical or physical impressions taken by a licensed healthcare provider. The splints and connectors are designed exclusively by the device manufacturer and its authorized partners to ensure consistent quality and performance.
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(147 days)
Re: K251628**
Trade/Device Name: Mandibular Advancement Device
Regulation Number: 21 CFR 872.5570
For Snoring And Obstructive Sleep Apnea
Production code: LRK
Regulation number: 21 CFR 872.5570
Name:** SnoreRx
Device Class: Class II
Product Code: LRK
Regulation Number: 21 CFR 872.5570
| SnoreRx | - |
| Model | L07 | / | - |
| Product Code | LRK | LRK | - |
| Regulation No. | 21 CFR 872.5570
| 21 CFR 872.5570 | - |
| Classification Name | Intraoral Device for Snoring and Obstructive Sleep Apnea
The Mandibular Advancement Device is designed to advance the user's lower jaw and maintain this position during use, opening the airway to reduce snoring during sleep. It is intended for adults with at least 18 years old.
The L07 Mandibular Advancement Device is an intraoral device that is used to maintain the lower jaw in a forward position to increase pharyngeal space so as to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.
The L07 Mandibular Advancement Device include three types: Type A, Type B, Type C. Each type includes one upper tray and one lower tray. The upper tray of these three types are the same, while they are only different in lower tray. By combining upper tray with different lower tray, the device can be used for advancing lower jaw from 0mm to 6mm.
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(270 days)
CHINA
Re: K250028
Trade/Device Name: Anti Snore Mouthpiece
Regulation Number: 21 CFR 872.5570
Regulatory Information**
Classification Name: Device, Anti-Snoring
Regulation Number: 21 CFR 872.5570
Anti Snore Mouthpiece | SilentZPro 2.0 | - |
| Classification | 2 | 2 | Same |
| Regulation | 21 CFR 872.5570
| 21 CFR 872.5570 | Same |
| Product code | LRK | LRK | Same |
| Indications for use | Anti snore mouthpiece
Anti snore mouthpiece is intended as an aid in the reduction of snoring for adults at least 18 years old.
Anti snore mouthpiece is an intraoral device composed of a maxillary and mandibular tray assembled to position the mandible forward relative to the maxilla to increase users' pharyngeal space and improve the ability to exchange air and decreases air turbulence, a causative factor in snoring.
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