FDA.reportPublic FDA data

ZIRKONZAHN.Implant-Planner incl. Bone & Tooth Segmentation

Primary DI
D800SY16600
Brand
ZIRKONZAHN.Implant-Planner incl. Bone & Tooth Segmentation
Company
ZIRKONZAHN SRL
Model
SY1660
Device description
Zirkonzahn.Implant-Planner incl. Bone & Tooth Segmentation module - LicenseThe conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for a period of 12 months!
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203765000ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-TrayZirkonzahn Srl2021-07-20LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D800SY16600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental treatment application softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
564251911
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D800ZRTA09010Prettau 5 98H10ZRTA09012026-09-18
D800ZRTA09110Prettau 5 98H14 with stepZRTA09112026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZRTA09212026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZRTA09312026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZRTA09412026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZRTA09512026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZRTA09622026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZRTA09712026-09-18
D800ZRTA106100Prettau 5 106H10ZRTA106102026-09-18
D800ZRTA106110Prettau 5 106H11ZRTA106112026-09-18
D800ZRTA106120Prettau 5 106H12ZRTA106122026-09-18
D800ZRTA106130Prettau 5 106H13ZRTA106132026-09-18
D800ZRTA106140Prettau 5 106H14ZRTA106142026-09-18
D800ZRTA106150Prettau 5 106H15ZRTA106152026-09-18
D800ZRTA106160Prettau 5 106H16ZRTA106162026-09-18
D800ZRTA106170Prettau 5 106H17ZRTA106172026-09-18
D800ZRTA106180Prettau 5 106H18ZRTA106182026-09-18
D800ZRTA106190Prettau 5 106H19ZRTA106192026-09-18
D800ZRTA106200Prettau 5 106H20ZRTA106202026-09-18
D800ZRTA106210Prettau 5 106H21ZRTA106212026-09-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20