Identity
- Trade Name
- ORTHOQUEST FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- Cervical Neck Pad Denim FDA UDI
- Model / Reference
- L0102 FDA UDI
- Description
- Cervical Neck Pad Denim FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10817713022222 FDA UDI
- 510(k) Number
- K940410 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic extraoral headgear
Orthoquest by Orthoquest, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K940410 also covers:
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Cervical Neckpads — ORTHO TECHNOLOGY, INC.
- Cervical Neckpads — ORTHO TECHNOLOGY, INC.
- High Pull Head Caps — ORTHO TECHNOLOGY, INC.
- High Pull Head Caps — ORTHO TECHNOLOGY, INC.
- ORTHOQUEST — ORTHOQUEST, 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 |
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Manufacturer
- Manufacturer
- Orthoquest, Inc.
Sources (1)
- FDA UDI b35753e4-3230-4169-a383-3312b42990ea 34 fields · synced Jun 1, 2026