Identity
- Trade Name
- SML FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- ZYPPAH VH FDA UDI
- Model / Reference
- 63760VHS FDA UDI
- Description
- ZYPPAH VH FDA UDI
Identifiers
- Primary DI / UDI-DI
- D85463760VHS1 FDA UDI
- 510(k) Number
- K091035 FDA UDI
- FDA Product Code
- LQZ FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
Yes
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Mandible-repositioning sleep-disordered breathing orthosis
SML, a removable intraoral mandible-repositioning sleep-disordered breathing orthosis, helps alleviate obstructive sleep apnea and snoring by repositioning the lower jaw. This is an advanced device that offers adjustable and fixed types with various techniques and materials, making it suitable for patients with different needs.
Similar devices
Also classified as Mandible-repositioning sleep-disordered breathing orthosis.
- Tap III Anti-Snoring Device — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class II
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- EMA — The Myerson Company Limited · Class II
- TAP 1 & 3 — Ortho Solutions LC · Class II
- EMA — The Myerson Company Limited · Class II
- SomnoDent ALPHA — SOMNOMED INC. · Class II
- EMA — The Myerson Company Limited · Class II
- Apnea Guard — Advanced Brain Monitoring, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Selane Products, Inc.
Sources (1)
- FDA UDI 78283b8e-6c7b-4b0b-9cc5-c554078349c7 34 fields · synced Jul 30, 2026