Blue Series – Hard
Respire Blue Series Hard is a custom oral appliance for adults with mild to moderate obstructive sleep apnea. Its upper and lower dental plates advance the lower jaw during sleep to…
Respire Blue Series Hard is a custom oral appliance for adults with mild to moderate obstructive sleep apnea. Its upper and lower dental plates advance the lower jaw during sleep to increase the airway opening. It is prescribed for use by one patient.
The plates are made from hard acrylic and connect at an angle that permits opening and closing the mouth while the appliance is worn. An anterior opening allows breathing through the mouth. An adjustment key changes the lower-jaw position.
Listed Item
Respire Blue Series – Hard
Retention and Removal
Ball clasps retain the hard acrylic version and can be tightened if the fit becomes loose. The upper and lower trays unhook for removal, and the appliance is cleaned daily.
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 | Respire LLC, United States |
|---|---|
| FDA product code | LRK |
| Device type | Device, Anti-Snoring |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K111207 |
| Record published | 2016-09-20 |
| Record revised | 2020-02-17 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Circumference 200 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SB000US | Circumference 200 mm | 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 |
|---|---|
| K214096 | 2022-05-31 |
| K192127 | 2020-02-05 |
| K170692 | 2017-05-26 |
| K152292 | 2015-12-07 |
| K150572 | 2015-08-27 |
| K131138 | 2013-09-09 |
| K111207 | 2011-08-23 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-09-01 | Class II | Device Design | Potential for device breakage during use | 2019-12-09 | |
| 2017-09-01 | Class II | Device Design | Potential for device breakage during use | 1 unit | 2019-12-09 |
| 2017-09-01 | Class II | Device Design | Potential for device breakage during use | 29 units | 2019-12-09 |
| 2017-09-01 | Class II | Device Design | Potential for device breakage during use | 25 units | 2019-12-09 |
| 2017-09-01 | Class II | Device Design | Potential for device breakage during use | 2019-12-09 |
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.