Identity
- Trade Name
- Ortho Specialties FDA UDI
- Generic Name
- Dental wedge, reusable FDA UDI
- Device Name
- Rotation Wedges, Gray FDA UDI
- Model / Reference
- 600-065 FDA UDI
- Description
- Rotation Wedges, Gray FDA UDI
Identifiers
- Catalog Number
- 600-065 FDA UDI
- Primary DI / UDI-DI
- 00840326411353 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Dental wedge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental wedge, reusable
Ortho Specialties by Young Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Henry Schein — HENRY SCHEIN, INC. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Wagotrix — GoldenDent · 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 333b0ee5-be7a-4b49-b817-e0abe46c5c03 35 fields · synced May 30, 2026