Identity
- Trade Name
- N!CE For Planmill FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- n!ce® for PlanMill®, LT C2, C14 FDA UDI
- Model / Reference
- Milling Materials FDA UDI
- Description
- n!ce® for PlanMill®, LT C2, C14 FDA UDI
Identifiers
- Catalog Number
- 010.7145 FDA UDI
- Primary DI / UDI-DI
- 07630031734983 FDA UDI
- 510(k) Number
- K173410 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental appliance fabrication material, ceramic
N!CE For Planmill by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173410 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Institut Straumann SA
Sources (1)
- FDA UDI 2bbb3c5c-87d3-4115-906e-f7b7583f0c96 37 fields · synced May 30, 2026