Identity
- Trade Name
- G&H REVERSE PULL FACE MASK, LARGE FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- The stainless steel frame is softened by hypo-allergenic chin and forehead pads to minimize irritation and maximize patient acceptance. Bilateral and bi-longitudinal adjust-ability allow for patient customization. Each mask also includes: 1 forehead pad, 2 chin pad and replacement screws. FDA UDI
- Model / Reference
- RPFMLG FDA UDI
- Description
- The stainless steel frame is softened by hypo-allergenic chin and forehead pads to minimize irritation and maximize patient acceptance. Bilateral and bi-longitudinal adjust-ability allow for patient customization. Each mask also includes: 1 forehead pad, 2 chin pad and replacement screws. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886000380 FDA UDI
- 510(k) Number
- K111169 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
Yes
FDA UDI
Category: Orthodontic extraoral headgear
G&H Reverse Pull Face Mask, Large by G&H Wire Company, 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
- Multi-Adjustable Facemask — Ortho Organizers, Inc. · Class II
- FACEMASK — Ortho Organizers, Inc. · Class II
- ClassOne — Ortho Organizers, Inc. · Class II
- 3M™ — 3M UNITEK CORPORATION · Class II
- Ortho Specialties — Young Innovations, Inc. · Class II
- Lancer Gear — LANCER ORTHODONTICS, INC. · Class II
Cleared under the same submission
K111169 also covers:
- G&H COLOR COATED FACEBOW — G&H Wire Company, Inc.
- G&H COLOR COATED FACEBOW — G&H Wire Company, Inc.
- G&H HIGH PULL HEADCAP — G&H Wire Company, Inc.
- G&H HIGH PULL HEADCAP — G&H Wire Company, Inc.
- G&H PROTRACTION FACE MASK, CHIN CUP — G&H Wire Company, Inc.
- G&H PROTRACTION FACE MASK, PADS — G&H Wire Company, Inc.
- G&H REVERSE PULL FACE MASK, CHIN & FOREHEAD PADS — G&H Wire Company, Inc.
- G&H REVERSE PULL FACE MASK, SCREWS — G&H Wire Company, Inc.
- G&H STANDARD FACEBOW — G&H Wire Company, Inc.
- G&H STANDARD FACEBOW — G&H Wire Company, Inc.
- G&H STANDARD FACEBOW — G&H Wire Company, Inc.
- G&H STANDARD FACEBOW — G&H Wire Company, 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
- G&H Wire Company, Inc.
Sources (1)
- FDA UDI af83b1d1-6179-4e9d-bab1-f28874dad474 35 fields · synced Jun 8, 2026