Identity
- Trade Name
- Swissmeda powered by Carestream Dental FDA UDI
- Generic Name
- Dental treatment application software FDA UDI
- Device Name
- Swissmeda powered by Carestream Dental FDA UDI
- Model / Reference
- 5944541 FDA UDI
- Description
- Swissmeda powered by Carestream Dental FDA UDI
Identifiers
- Catalog Number
- 5944541 FDA UDI
- Primary DI / UDI-DI
- 60192155944543 FDA UDI
- 510(k) Number
- K112251 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental treatment application software
Swissmeda powered by Carestream Dental by Carestream Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental treatment application software.
- IPS CaseDesigner® — Nobel Biocare AG · Class II
- IPS CaseDesigner® — Nobel Biocare AG · Class II
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carestream Dental LLC
Sources (1)
- FDA UDI 90b8fec4-12bf-4166-ad9d-369967dd5198 35 fields · synced Jun 8, 2026