Identity
- Trade Name
- OPTRAGATE FDA UDI
- Generic Name
- Dental cheek retractor, professional, single-use FDA UDI
- Device Name
- OptraGate Junior Refill/80 FDA UDI
- Model / Reference
- 591451WW FDA UDI
- Description
- OptraGate Junior Refill/80 FDA UDI
Identifiers
- Catalog Number
- 591451WW FDA UDI
- Primary DI / UDI-DI
- DVIV591451WW1 FDA UDI
- FDA Product Code
- EIF FDA UDI
- GMDN Term
- Dental cheek retractor, professional, single-use 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental cheek retractor, professional, single-use
Optragate by Ivoclar Vivadent Aktiengesellschaft — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cheek retractor, professional, single-use.
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- Cheek Retractor — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- Denovo Clearfield cheek retractors — DENOVO DENTAL INC · Class I
- Geistlich Panorama — DSSM AG · Class I
- Ortho Organizers — Ortho Organizers, 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
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI e606cfd7-169a-4b4c-a8a1-ece7138b905f 34 fields · synced May 30, 2026