ZIRKONZAHN.Implant-Planner incl. Bone & Tooth Segmentation

FDA UDI

Class II (US FDA UDI)

by Zirkonzahn GmbH

Identity

Trade Name: ZIRKONZAHN.Implant-Planner incl. Bone & Tooth Segmentation FDA UDI
Generic Name: Dental treatment application software FDA UDI
Device Name: Zirkonzahn.Implant-Planner incl. Bone & Tooth Segmentation module - License The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for a period of 12 months! FDA UDI
Model / Reference: SY1660 FDA UDI
Description: Zirkonzahn.Implant-Planner incl. Bone & Tooth Segmentation module - License The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for a period of 12 months! FDA UDI

Identifiers

Primary DI / UDI-DI: D800SY16600 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental treatment application software

ZIRKONZAHN.Implant-Planner incl. Bone & Tooth Segmentation by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Blue Sky Bio, LLC. — BLUE SKY BIO LLC · Class II

Cleared under the same submission

K203765 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: Zirkonzahn GmbH

Sources (1)

FDA UDI f3929d1d-21f1-4f9b-b620-7d61d85056c0 34 fields · synced May 30, 2026