Identity
- Trade Name
- P.P. ApicalShaper Z40 FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- 100 units FDA UDI
- Model / Reference
- PP-440 FDA UDI
- Description
- 100 units FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810092939221 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
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: Endodontic paper point
P.P. ApicalShaper Z40 by Nusmile, Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endodontic paper point.
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- MM MARKED PAPER POINTS — DiaDent Group International · Class I
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- 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
- Nusmile, Ltd
Sources (1)
- FDA UDI 14d14c08-c032-409f-9f62-819ee47e1774 34 fields · synced May 31, 2026