Identity
- Trade Name
- Flexi-Flange FDA UDI
- Generic Name
- Endodontic stopper FDA UDI
- Device Name
- Flexi-Flange Depth Gauge FDA UDI
- Model / Reference
- 496-00 FDA UDI
- Description
- Flexi-Flange Depth Gauge FDA UDI
Identifiers
- Catalog Number
- 496-00 FDA UDI
- Primary DI / UDI-DI
- 00766054002178 FDA UDI
- FDA Product Code
- EIL FDA UDI
- GMDN Term
- Endodontic stopper 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic stopper
Flexi-Flange by Essential Dental Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic stopper.
- Stopper — DENTIS CO. , LTD · Class I
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- Stopper — DENTIS CO. , LTD · Class I
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- Lateral Stopper — DENTIS CO. , LTD · Class I
- Crestal Stopper — DENTIS CO. , LTD · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Drilling Guide Wheel — DENTIS CO. , LTD · 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
- Essential Dental Systems, Inc.
Sources (1)
- FDA UDI abdae6bc-17fb-4cf9-8815-44e1b7735c79 35 fields · synced May 31, 2026