Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010905160

FEI Number

3010905160

Entity Name

PRITIDENTA GMBH

City/State/Country

Leinfelden-Echterdingen Baden-Wurttemberg, DE

Establishment Address

Meisenweg 37, Leinfelden-Echterdingen Baden-Wurttemberg D-70771, DE

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

pritidenta GmbH (Owner Number: 10047178)

Owner / Operator Contact Address

Meisenweg 37, Leinfelden-Echterdingen, DE-NOTA D-70771, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102128

PMA Number

N/A

All Registered Proprietary Names

pritimultidisc ZrO2 High Translucent pritimultibloc ZrO2 High Translucent Tizian Block 5 Multilayer 5YZirconia High Translucent priti®crown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2017-02-07
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2014-07-11

Official Correspondent

David Figge

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

pritidenta GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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3031595584	ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD	Taizhou Zhejiang, CN
3030464310	DOCTUS GLOBAL	Goyang-si, Gyeonggi-do, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010905160. Last updated year: 2026. Please use registration number 3010905160 when referencing this establishment in official correspondence.