Identity
- Trade Name
- ZIRKONZAHN.Implant-Planner Practice FDA UDI
- Generic Name
- Dental treatment application software FDA UDI
- Device Name
- Rights of use Zirkonzahn.Implant-Planner Practice The conclusion of the Zirkonzahn.Implant-Planner Practice service contract is obligatory for the duration of 12 months! Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner Practice FDA UDI
- Model / Reference
- SY1620 FDA UDI
- Description
- Rights of use Zirkonzahn.Implant-Planner Practice The conclusion of the Zirkonzahn.Implant-Planner Practice service contract is obligatory for the duration of 12 months! Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner Practice FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800SY1620 FDA UDI
- 510(k) Number
- K203765 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Dental treatment application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental treatment application software
ZIRKONZAHN.Implant-Planner Practice by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Zirkonzahn GmbH
Sources (1)
- FDA UDI ef0e7d54-b0fb-43d5-9d99-1f197c87abf0 35 fields · synced May 31, 2026