Dorsal Comfort Fit
The Sapphire Dorsal Comfort Fit is a custom oral appliance that repositions the lower jaw during sleep. It is intended to reduce nighttime snoring and mild to moderate obstructive sleep…
The Sapphire Dorsal Comfort Fit is a custom oral appliance that repositions the lower jaw during sleep. It is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in patients aged 18 or older.
Fitted trays cover the upper and lower teeth. An expansion screw mechanism allows the dentist or physician to adjust mandibular advancement in small increments, increasing the space available in the throat.
Listed Item
The Sapphire Dorsal Comfort Fit is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of custom fitted trays which fit over the upper and lower teeth. The device functions as a mandibular repositioner, which acts to increase the patient’s pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has an expansion screw adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
Fitting and Follow-up
The trays are made from medical-grade acrylic and distribute repositioning forces across the dental arch. The prescribing dentist evaluates the temporomandibular joint before treatment and reviews persistent jaw discomfort during use. The appliance permits oral breathing.
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (1), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Dongguan Yiyao Science & Technology Development Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Dongyang City Yonoel Outdoor Products Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 32 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Zhuhai DS Dental Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 8 |
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Crane Dental Laboratory, United States |
|---|---|
| FDA product code | LRK |
| Device type | Device, Anti-Snoring |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K181416 |
| Record published | 2023-03-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Emerald Herbst | Island Dental LAB DBA Emerald Dental LAB | 141 |
| EMA | The Myerson Company Limited | 94 |
| Apnea Guard | Advanced Brain Monitoring, Inc. | 32 |
| SML | Selane Products, Inc. | 32 |
| SomnoDent Avant | Somnomed, Ltd. | 11 |
| Itus Mouthguardz | Shinrin-Yoku Traders LLC | 8 |
| Virtus | Somnomed, Ltd. | 7 |
| Silent Nite Sleep Appliance with Glidewell Hinge | Prismatik Dentalcraft, Inc. | 7 |
| ZQuiet S.A. | Sleeping Well, LLC | 6 |
| Zyppah | A.M.A. Plastics | 6 |
| AIRvance™ | Medtronic Xomed, Inc. | 5 |
| Anti-snoring, restoration | Modern Dental Laboratory (DG) Co., Ltd. | 4 |
Showing 12 of 209. All products under Device, Anti-Snoring
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181416 | 2019-09-17 |
| K140429 | 2014-09-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.