Identity
- Trade Name
- Respire Pink Series with DentiTrac - H FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring. FDA UDI
- Model / Reference
- SPD000US FDA UDI
- Description
- Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851861007161 FDA UDI
- 510(k) Number
- K170692 FDA UDI
- FDA Product Code
- PLC 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
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Circumference — 200 Millimeter FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
Respire Pink Series with DentiTrac - H by Respire Medical Holdings — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mandible-repositioning sleep-disordered breathing orthosis.
- Tap III Anti-Snoring Device — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. · Class II
- SML — Selane Products, Inc. · Class II
- SML — Selane Products, Inc. · Class II
- Rest Assured — RANIR LLC · Class II
- 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
Cleared under the same submission
K170692 also covers:
- Respire Pink Series EF Micro with DentiTrac — Respire Medical Holdings
- Respire Pink Series EF with DentiTrac — Respire Medical Holdings
- Respire Pink Series H/S with DentiTrac — Respire Medical Holdings
- Respire Pink Series Micro H/S with DentiTrac — Respire Medical Holdings
- Respire Pink Series Micro with DentiTrac — Respire Medical Holdings
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
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
- Respire Medical Holdings
Sources (1)
- FDA UDI f6349593-512a-4e4d-a5cc-682c5c094d71 36 fields · synced May 29, 2026