ENVISIONTEC GMBH

FDA Device Registration & Listing · Gladbeck North Rhine-Westphalia, DE · Registration 3012389497

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
3012389497
FEI Number
3012389497
Entity Name
ENVISIONTEC GMBH
City/State/Country
Gladbeck North Rhine-Westphalia, DE
Establishment Address
Bruesseler Strasse 51, Gladbeck North Rhine-Westphalia D-45968, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
EnvisionTEC GmbH (Owner Number: 10053558)
Owner / Operator Contact Address
Bruesseler Strasse 51, Gladbeck, DE-NW D-45968, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Flexcera™ Smile Ultra+ E-Temp Flexcera™ Base E1-Guide Soft C-29C NP Swabs E-Guard blue E-Guard E-Guide SmileGuard Flexcera™ Smile Flexcera™ Smile Ultra+ Flexcera™ Smile Ultra+ E-Dent 1000 Flexcera™ Base Ultra+ E-Tray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2022-01-13
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2021-04-06
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2020-04-03
MQC Mouthguard, Prescription Unknown Class U N/A 2020-11-30
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2020-11-30
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2016-12-19
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2022-06-27
MQC Mouthguard, Prescription Unknown Class U N/A 2022-06-27
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2021-06-28
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2022-01-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2022-01-13
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2022-01-13
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2020-10-07

Official Correspondent

Mindy McCann

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

EnvisionTEC 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
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19
K070591 Union Dental S.A./Unidesa.Odi REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH 2007-05-11
K915276 Nobelpharma USA, Inc. DENTURE PLASTIC TEETH,76 ELM 1992-02-03
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - 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 3012389497. Last updated year: 2026. Please use registration number 3012389497 when referencing this establishment in official correspondence.
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