Identity
- Trade Name
- ProShape One Paper Points Primary FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Model / Reference
- SDGP50061 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810138822309 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
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ProShape One Paper Points Primary by Endo Direct, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Endo Direct, Llc
Sources (1)
- FDA UDI 3d562ce6-754b-4501-8873-3f2c36484164 33 fields · synced Jun 1, 2026