FDA UDI
In Commercial Distribution
🇺🇸 United States
ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation
DI: D800SY16700
·
Model: SY1670
·
ZIRKONZAHN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation
- Primary DI
- D800SY16700
- Version / Model
- SY1670
- Company Name
- ZIRKONZAHN SRL
- Labeler DUNS
- 564251911
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-05
- Public Version
- 1
- Public Version Date
- 2025-09-15
- Public Version Status
- New
- Public Device Record Key
- d2bdd840-4e8d-4146-abb7-3bda0fab0477
Device Description
Zirkonzahn.Implant-Planner Practice incl. Bone & Tooth Segmentation module - License The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for a period of 12 months!
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60883 | Dental treatment application software | An application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for dental equipment (e.g., a line-powered dental drilling system). It is typically for installation in an off-the-shelf desktop, laptop or tablet computer, which may require a connection to the dental equipment. It typically includes upgrades to the software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D800SY16700 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203765 | 000 |