Identity
- Trade Name
- Safety Release Modules Heavy FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- Safety Release Modules For Intraoral And Extraoral Headgear-32 Ounce Heavy FDA UDI
- Model / Reference
- 600-559 FDA UDI
- Description
- Safety Release Modules For Intraoral And Extraoral Headgear-32 Ounce Heavy FDA UDI
Identifiers
- Catalog Number
- 600-559 FDA UDI
- Primary DI / UDI-DI
- 00842452100675 FDA UDI
- 510(k) Number
- K961754 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
Yes
FDA UDI
Category: Orthodontic extraoral headgear
Safety Release Modules Heavy by Ortho Specialties — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic extraoral headgear.
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- 3M™ — 3M UNITEK CORPORATION · Class II
Cleared under the same submission
K961754 also covers:
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Safety Release Modules Light — ORTHO SPECIALTIES
- Saftey Release Modules Medium — ORTHO SPECIALTIES
- ClassOne — Ortho Organizers, Inc.
- ClassOne — Ortho Organizers, Inc.
- ClassOne — Ortho Organizers, Inc.
- Masel — Ortho Organizers, Inc.
- Masel — Ortho Organizers, Inc.
- Ortho Specialties — Young Innovations, Inc.
- OrthoQuest — Young Innovations, Inc.
- The Orthodontic Store — Young Innovations, 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 Specialties
Sources (1)
- FDA UDI 9496e699-fe37-4a41-b0dd-01ea54b55f62 36 fields · synced Jun 8, 2026