EMA
- Primary DI
- 00860015650405
- Brand
- EMA
- Company
- DENTAL PROSTHETIC SERVICES, INC.
- Model
- EMA 3D
- Device description
- A customized, removable, and patient adjustable intraoral device, fabricated using 3d printing or milling technology, that utilizes interchangeable elastic straps of varying lengths and strengths to advance the mandible forward and open the bite.
- Published
- 2026-04-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
Product Code Classifications#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00860015650405 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00860015650405 | 00860015650405 | 860015650405 | 0860015650405 |
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. |
Regulatory Flags#
- DUNS number
- 065227423
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
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 |
| 00850077473029 | EMA 3D PATIENT STARTER KITS | EMA SLEEP INCORPORATED | LQZ | 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 |