Respire Pink AT Hard
Respire Pink AT Hard is a custom oral appliance for mild to moderate obstructive sleep apnea in patients aged 18 years or older. It advances the lower jaw during sleep to help maintain an…
Respire Pink AT Hard is a custom oral appliance for mild to moderate obstructive sleep apnea in patients aged 18 years or older. It advances the lower jaw during sleep to help maintain an open airway.
Dental acrylic resins and metal components form the patient-specific appliance. A telescopic arm links the arches and permits adjustment of mandibular advancement as treatment is titrated.
Advancement Mechanism
The AT arm uses a self-contained hinge and readable adjustment mechanism. Its maximum advancement range is 7 mm, allowing incremental changes within the prescribed treatment arrangement.
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) | K192127 |
| Record published | 2020-02-13 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPAT000US | 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.