Identity
- Trade Name
- IPS CaseDesigner® FDA UDI
- Generic Name
- Dental treatment application software FDA UDI
- Device Name
- IPS CaseDesigner 2.2 Win 64-bit FDA UDI
- Model / Reference
- 2.2 FDA UDI
- Description
- IPS CaseDesigner 2.2 Win 64-bit FDA UDI
Identifiers
- Catalog Number
- 300011 FDA UDI
- Primary DI / UDI-DI
- 07332747181913 FDA UDI
- 510(k) Number
- K200810 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
IPS CaseDesigner® by Nobel Biocare AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental treatment application software.
- SMARTDent — Ray Co., Ltd · Class II
- MSOFT Dental Planning System — Swissmeda AG · Class II
- ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation — Zirkonzahn GmbH · Class II
- OsstellConnect — Osstell AB · Class I
- iChiropro Surgery APP — Bien-Air Dental SA · Class I
- Swissmeda Dental Planning System — Swissmeda AG · Class II
- Blue Sky Bio, LLC. — BLUE SKY BIO LLC · Class II
- Blue Sky Bio, LLC. — BLUE SKY BIO LLC · Class II
Cleared under the same submission
K200810 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 |
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Manufacturer
- Manufacturer
- Nobel Biocare AG
Sources (1)
- FDA UDI 1663c02d-c96b-497f-b2fa-fb751ecba0d7 36 fields · synced May 31, 2026