Identity
- Trade Name
- HyFlex™ Paper Points FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- HyFlex™ CM Paper Points 0.04 # 25 FDA UDI
- Model / Reference
- 60022673 FDA UDI
- Description
- HyFlex™ CM Paper Points 0.04 # 25 FDA UDI
Identifiers
- Catalog Number
- 60022673 FDA UDI
- Primary DI / UDI-DI
- E165600226731 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
Yes
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
HyFlex™ Paper Points by Coltène/Whaledent AG — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coltène/Whaledent AG
Sources (1)
- FDA UDI 55d81c9b-d3c9-49fb-907b-fac98db16ba4 36 fields · synced May 30, 2026