Identity
- Trade Name
- Multi-Adjustable Facemask FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- Multi-Adjustable Facemask-Blue FDA UDI
- Model / Reference
- 426-055 FDA UDI
- Description
- Multi-Adjustable Facemask-Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707097684 FDA UDI
- 510(k) Number
- K000358 FDA UDI
- FDA Product Code
- DZB FDA UDI
- GMDN Term
- Orthodontic extraoral headgear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic extraoral headgear
Multi-Adjustable Facemask by Ortho Organizers, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic extraoral headgear.
- 3M™ — 3M UNITEK CORPORATION · Class II
- 3M™ — 3M UNITEK CORPORATION · Class II
- ODP FACEMASK, REVERSE PULL — G&H Wire Company, Inc. · Class II
- G&H COLOR COATED FACEBOW — G&H Wire Company, Inc. · Class II
- 3M™ — 3M UNITEK CORPORATION · Class II
- Ortho Specialties — Young Innovations, Inc. · Class II
- Lancer Gear — LANCER ORTHODONTICS, INC. · Class II
- Morales Eco Protraction Face Mask — Ortosim, S.A. de C.V. · Class II
Cleared under the same submission
K000358 also covers:
- Multi-Adjustable Face Mask — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- American Flag Class III Adjustable Facemask — ORTHO SPECIALTIES
- Flames Class III Adjustable Facemask — ORTHO SPECIALTIES
- Hawaiian Print Class III Adjustable Facemask — ORTHO SPECIALTIES
- Leopard Print Class III Adjustable Facemask — ORTHO SPECIALTIES
- Multi-Adjustable Facemask — ORTHO SPECIALTIES
- ClassOne — Ortho Organizers, Inc.
- ClassOne — Ortho Organizers, Inc.
- ClassOne — Ortho Organizers, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho Organizers, Inc.
Sources (1)
- FDA UDI 4ea8805f-688d-4a50-9924-f340c35994b3 34 fields · synced Jun 9, 2026