ZQuiet S.A.
- Primary DI
- 00858522003258
- Brand
- ZQuiet S.A.
- Company
- SLEEPING WELL, LLC
- Model
- ZQSA-XDC
- Device description
- ZQuiet S.A. Dental Size C Single Unit
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| LRK | Device, Anti-Snoring |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LRK | Device, Anti-Snoring | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K140777 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10858522003255 | Package | GS1 | 12 | In Commercial Distribution |
| 00858522003258 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10858522003255 | 10858522003255 | ||
| 00858522003258 | 00858522003258 | 858522003258 | 0858522003258 |
GMDN Terms#
| Term | Definition |
|---|---|
| Mandible-repositioning sleep-disordered breathing orthosis | A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 020904101
- Device count
- 1
- DM exempt
- true
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00858522003173 | ZQuiet | ZQ2PK | 2016-09-24 | |
| 00858522003227 | ZQuiet S.A. | ZQSA-XM | 2016-09-24 | |
| 00858522003234 | ZQuiet S.A. | ZQSA-XDA | 2016-09-24 | |
| 00858522003241 | ZQuiet S.A. | ZQSA-XDB | 2016-09-24 | |
| 00858522003265 | ZQuiet S.A. | ZQSA-XDD | 2016-09-24 | |
| 00858522003289 | ZQuiet S.A. | ZQSA-XD12M | 2016-09-24 | |
| 00858522003180 | ZQuiet | ZQC1 | 2016-09-24 | |
| 00858522003197 | ZQuiet | ZQC2 | 2016-09-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00850077473005 | EMA NOW PATIENT STARTER KITS | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473012 | EMA Serena Patient Starter kits | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473043 | INDIVIDUAL EMA STRAPS(EMAST13W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473050 | Individual EMA Straps(EMAST14W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473067 | Individual EMA Straps(EMAST15W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473074 | Individual EMA Straps(EMAST16W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473081 | Individual EMA Straps(EMAST17W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473098 | Individual EMA Straps(EMAST18W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473104 | Individual EMA Straps(EMAST19W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473111 | Individual EMA Straps(EMAST20W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473128 | Individual EMA Straps(EMAST21W) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473135 | Individual EMA Straps(EMAST13Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473142 | Individual EMA Straps(EMAST14Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473159 | Individual EMA Straps(EMAST15Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473166 | Individual EMA Straps(EMAST16Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473173 | Individual EMA Straps(EMAST17Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473180 | Individual EMA Straps(EMAST18Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473197 | Individual EMA Straps(EMAST19Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473203 | Individual EMA Straps(EMAST20Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473210 | Individual EMA Straps(EMAST21Y) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473227 | Individual EMA Straps(EMAST13B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473234 | Individual EMA Straps(EMAST14B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473241 | Individual EMA Straps(EMAST15B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473258 | Individual EMA Straps(EMAST16B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473265 | Individual EMA Straps(EMAST17B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473272 | Individual EMA Straps(EMAST18B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473289 | Individual EMA Straps(EMAST19B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473296 | Individual EMA Straps(EMAST20B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473302 | Individual EMA Straps(EMAST21B) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |
| 00850077473319 | Individual EMA Straps(EMAST13C) | EMA SLEEP INCORPORATED | LRK | 2026-08-14 |