STRATASYS LTD

FDA Device Registration & Listing · Kiryat Gat Southern, IL · Registration 3016074824

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016074824
FEI Number
3016074824
Entity Name
STRATASYS LTD
City/State/Country
Kiryat Gat Southern, IL
Establishment Address
10 Habarzel st, Kiryat Gat Southern 8258310, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Stratasys Ltd (Owner Number: 10086646)
Owner / Operator Contact Address
1 Holtzman street, Rehovot, IL-M 7670401, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TrueDent Magenta TrueDent Clear TrueDent White TrueDent Yellow TrueDent Cyan MED610-DSG MED610

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2022-11-29
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2022-11-29
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2022-11-29
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2022-11-29
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2023-12-14

Official Correspondent

Dafna Fitoussi

US Agent Details

Michelle Ford Business: Stratasys Inc. Email: Michelle.ford@stratasys.com Phone: (704) 6185948

Related Public Records

Same Entity

Stratasys Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017374693 STRATASYS LTD - Headquarter Rehovot Central, IL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01
K153476 Kuraray Noritake Dental, Inc. KATANA AVENCIA Block 2016-08-23
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016074824. Last updated year: 2026. Please use registration number 3016074824 when referencing this establishment in official correspondence.
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