DELTAMED GMBH

FDA Device Registration & Listing · FRIEDBERG Hesse, DE · Registration 3002789526

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
3002789526
FEI Number
3002789526
Entity Name
DELTAMED GMBH
City/State/Country
FRIEDBERG Hesse, DE
Establishment Address
RAIFFEISENSTR. 8a, FRIEDBERG Hesse D-61169, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DELTAMED GMBH (Owner Number: 9026386)
Owner / Operator Contact Address
RAIFFEISENSTR. 8a, --, FRIEDBERG, DE-HE 61169, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Renamel® Flowable Microhybrid Renamel® Microhybrid 3Delta Crown PRO Resins Crown X 3Delta Denture Teeth PRO Resins Tooth X Prevue® PRO Resins Arch X RS VIVO C&B Ultimate 3Delta UNlimited Insure® Lite Insure® Lite Automix Insure® P pro Crown & Bridge 3Delta Etemp Renamel® Gingafill® Creative Color® Pink Opaque™ Creative Color® Tint Creative Color® Clear Liquid Resin Creative Color® Opaquer P pro Splint COSMESEAL® Clear COSMESEAL® Filled Renamel® Microfill P pro Try-In RS VIVO Try-In 3Delta Try-In XT Renamel® NANO™ +plus PRO Resins Guide X P Pro Surgical Guide Clear 3Delta Guide XT RS VIVO Guide Brush & Sculpt™ Renamel® Bulkfill 3Delta Denture Fix 3Delta Denture Bond 3Delta Denture Base PRO Resins Base X PRO Resins Denture Fix ACRIFIX Bonder PRO Resins Denture Bond RS VIVO Tray RS Impression Tray P pro Impression Tray Green 3 Delta Tray 3Delta Tray Rose

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2022-12-06
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2022-01-19
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2022-09-16
EMA Cement, Dental Dental Class 2 872.3275 2008-04-03
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2025-02-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2025-02-12
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2025-02-12
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2025-02-12
EMA Cement, Dental Dental Class 2 872.3275 2008-04-03
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2020-08-05
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-04-03
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2020-01-23
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-04-03
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2019-05-02
EEA Plate, Base, Shellac Dental Class 1 872.6200 2018-12-18
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2019-05-02
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2018-12-18
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2009-12-01
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2021-08-30
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2022-01-19
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2022-01-19
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2018-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

Mary Beth Nowak Business: COSMEDENT, INC. Email: regulatory@cosmedent.com Phone: (800) 6216729

Related Public Records

Same Entity

DELTAMED 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
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
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08

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 3002789526. Last updated year: 2026. Please use registration number 3002789526 when referencing this establishment in official correspondence.
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