EMA
EMA first step maxillary buttons (2 pieces) & EMA first step maxillary buttons with bite pads attached (2 pieces)
8manufacturers in China registered for this device type
94catalogue numbers in this listing
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 | The Myerson Company Limited, TT |
|---|---|
| FDA product code | LRK |
| Device type | Device, Anti-Snoring |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K971794 |
| Record published | 2016-09-24 |
| Record revised | 2024-11-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 13 to 21 mm; height 0.035 to 19 mm; outer diameter 120 to 125 mm; height 5 in; length 5 in |
| Distribution end date | 2024-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EMATD12508 | Height 2.0 mm | In distribution |
| EMAKT12510 | Height 2.5 mm | In distribution |
| EMAST17WSB | Length 17 mm | In distribution |
| EMAST13WS | Length 13 mm | In distribution |
| EMAST19CE | Length 19 mm | In distribution |
| EMAST17CEB | Length 17 mm | In distribution |
| EMAKT12010 | Height 2.5 mm | In distribution |
| EMAST17WS | Length 17 mm | In distribution |
| EMAST17CE | Length 17 mm | In distribution |
| EMAST14BF | Length 14 mm | In distribution |
| EMAST13YMB | Length 13 mm | In distribution |
| EMAST20WSB | Length 20 mm | In distribution |
| EMAST19CEB | Length 19 mm | In distribution |
| EMAST18BF | Length 18 mm | In distribution |
| EMAST17YMB | Length 17 mm | In distribution |
| EMAST14CE | Length 14 mm | In distribution |
| EMAST14BFB | Length 14 mm | In distribution |
| EMATD12510 | Height 2.5 mm | In distribution |
| EMAST13BF | Length 13 mm | In distribution |
| EMAST21CEB | Length 21 mm | In distribution |
| EMAST15YM | Length 15 mm | In distribution |
| EMAST14WS | Length 14 mm | In distribution |
| EMAST19YM | Height 19 mm | In distribution |
| EMASA | In distribution | |
| EMAST18BFB | Length 18 mm | In distribution |
| EMAST15CE | Length 15 mm | In distribution |
| EMAST21BFB | Length 21 mm | In distribution |
| EMAST15BF | Length 15 mm | In distribution |
| EMAST13BFB | Length 13 mm | In distribution |
| EMATD12008 | Height 2.0 mm | In distribution |
| EMAST21YMB | Length 21 mm | In distribution |
| EMAGLDW | In distribution | |
| EMAKT12508 | Height 2.0 mm | In distribution |
| EMAST16BF | Length 16 mm | In distribution |
| EMAKT12008 | Height 2.0 mm | In distribution |
| EMAST18YM | Length 18 mm | In distribution |
| EMAST16CE | Length 16 mm | In distribution |
| EMAST15WSB | Length 15 mm | In distribution |
| EMAST14YM | Length 14 mm | In distribution |
| EMAST21BF | Length 21 mm | In distribution |
| EMAST20BFB | Length 20 mm | In distribution |
| EMAST13YM | Length 13 mm | In distribution |
| EMAST18CE | Length 18 mm | In distribution |
| EMABN2B | In distribution | |
| EMAST16YM | Length 16 mm | In distribution |
| EMAST16WS | Length 16 mm | In distribution |
| EMAST20CE | Length 20 mm | In distribution |
| EMAST19WS | Length 19 mm | In distribution |
| EMAST14CEB | Length 14 mm | In distribution |
| EMAST18CEB | Length 18 mm | In distribution |
| EMAST16CEB | Length 16 mm | In distribution |
| EMAST16YMB | Length 16 mm | In distribution |
| EMAST17BFB | Length 17 mm | In distribution |
| EMAST20BF | Length 20 mm | In distribution |
| EMAST15WS | Length 15 mm | In distribution |
| EMAST21CE | Length 21 mm | In distribution |
| EMAST20YM | Length 20 mm | In distribution |
| EMAST18YMB | Length 18 mm | In distribution |
| EMAST15BFB | Length 15 mm | In distribution |
| EMAST20CEB | Length 20 mm | In distribution |
| EMABPB | In distribution | |
| EMAST21WSB | Length 21 mm | In distribution |
| EMAST13CE | Length 13 mm | In distribution |
| EMAST13WSB | Length 13 mm | In distribution |
| EMAST21WS | Length 21 mm | In distribution |
| EMAST18WSB | Length 18 mm | In distribution |
| EMAST18WS | Length 18 mm | In distribution |
| EMAST14WSB | Length 14 mm | In distribution |
| EMAST14YMB | Length 14 mm | In distribution |
| EMAST21YM | Length 21 mm | In distribution |
| EMAST13CEB | Length 13 mm | In distribution |
| EMAST19BFB | Length 19 mm | In distribution |
| EMAST19WSB | Length 19 mm | In distribution |
| EMAST20WS | Length 20 mm | In distribution |
| EMAST20YMB | Length 20 mm | In distribution |
| EMABP | In distribution | |
| EMAST17BF | Length 17 mm | In distribution |
| EMAST16BFB | Length 16 mm | In distribution |
| EMAST17YM | Length 17 mm | In distribution |
| EMAST15YMB | Length 15 mm | In distribution |
| EMAST16WSB | Length 16 mm | In distribution |
| EMAST19BF | Length 19 mm | In distribution |
| EMABN2 | In distribution | |
| EMAST19YMB | Length 19 mm | In distribution |
| EMATD12010 | Height 2.5 mm | In distribution |
| EMAST15CEB | Height 15 mm | In distribution |
| EMAFSVSR120 | Height 0.035 mm | Withdrawn |
| EMAFSVS | Height 5 in | Withdrawn |
| EMAFSKT | Length 5 in | Withdrawn |
| EMARK | Withdrawn | |
| EMAFSK125 | Outer Diameter 125 mm | Withdrawn |
| EMAFSK120 | Outer Diameter 120 mm | Withdrawn |
| EMAFSVSR125 | Height 0.035 mm | Withdrawn |
| EMAFSB | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Emerald Herbst | Island Dental LAB DBA Emerald Dental LAB | 141 |
| 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 |
| EMA Custom | The Myerson Company Limited | 4 |
Showing 12 of 209. All products under Device, Anti-Snoring
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.