Identity
- Trade Name
- The Orthodontic Store FDA UDI
- Generic Name
- Orthodontic palate expander screw key FDA UDI
- Device Name
- Ez Key FDA UDI
- Model / Reference
- 620-710 FDA UDI
- Description
- Ez Key FDA UDI
Identifiers
- Catalog Number
- 620-710 FDA UDI
- Primary DI / UDI-DI
- 00840326409305 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Orthodontic palate expander screw key FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Orthodontic palate expander screw key
The Orthodontic Store by Young Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic palate expander screw key.
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- OSE — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class I
- ATOZ Key — M.K. Meditech Co. , Ltd. · Class I
- ATOZ Expander Kit — M.K. Meditech Co. , Ltd. · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations, Inc.
Sources (1)
- FDA UDI 99b3c4bb-65eb-4e04-94d1-6e31d55f0ab5 35 fields · synced Jun 8, 2026