Identity
- Trade Name
- EdgeOne™ FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- Classic Fit EdgeOne™ Paper Points Primary FDA UDI
- Model / Reference
- 8806387821663_1 FDA UDI
- Description
- Classic Fit EdgeOne™ Paper Points Primary FDA UDI
Identifiers
- Catalog Number
- 8806387821663_1 FDA UDI
- Primary DI / UDI-DI
- 10818365021670 FDA UDI
- FDA Product Code
- EKN FDA UDI
- GMDN Term
- Endodontic paper point FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3830 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: Endodontic paper point
EdgeOne™ by US Endodontics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic paper point.
- EndoEssentials™ Absorbent Paper Points 200 - XC — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- Absorbant Paper Points, 45 — Meta Biomed, Inc. · Class I
- ABSORBENT PAPER POINTS — DiaDent Group International · Class I
- ABSORBENT PAPER POINTS — DiaDent Group International · Class I
- Absorbant Paper Points, 10 — Meta Biomed, Inc. · Class I
- MM MARKED PAPER POINTS — DiaDent Group International · Class I
- Roydent Absortbent paper Points Zipperer — ROYDENT DENTAL PRODUCTS INC · Class I
- MM MARKED PAPER POINTS — DiaDent Group International · 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
- US Endodontics, LLC
Sources (1)
- FDA UDI 9364e070-5576-4368-a463-69aff1c1d759 35 fields · synced May 30, 2026