Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000486347

FEI Number

1000486347

Entity Name

DREVE DENTAMID GMBH

City/State/Country

UNNA North Rhine-Westphalia, DE

Establishment Address

MAX-PLANCK-STR. 31, UNNA North Rhine-Westphalia 59423, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DREVE DENTAMID GMBH (Owner Number: 9042374)

Owner / Operator Contact Address

MAX-PLANCK-STRASSE 31, UNNA, DE-NW 59423, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tips Application tips Mixing tips FotoDent guide Fixtemp C&B 4:1 Primeprint Direct Aligner Drufosoft pro Drufosoft BioBleach hart/soft Odontosil 50/60 Odontosil 2K Lack Drufolen H Kombiplast Biolon FotoDent denture NanoVarnish Plaquit FotoDent TryIn

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2012-05-02
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2015-06-12
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2015-06-16
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2024-06-03
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-11-17
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2004-12-28
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2021-01-07
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2018-04-09
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	2026-02-19

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Nickoloff Business: DREVE AMERICA CORP. Email: Robert.Nickoloff@Dreve-America.com Phone: (651) 3249494

Related Public Records

Same Entity

DREVE DENTAMID 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
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K093019	Enamelite, LLC	ENAMELITE ACRYSEAL SPRAY SEALANT	2009-12-22
K030585	Bisco, Inc.	SCULPTING RESIN	2003-04-28

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.

Similar Registrations

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2018957	DEN-MAT HOLDINGS, LLC	Lompoc, CA, US
3005558160	MAXILL, INC.	ST. THOMAS Ontario, CA
9611385	Solventum Germany GmbH	SEEFELD Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000486347. Last updated year: 2026. Please use registration number 1000486347 when referencing this establishment in official correspondence.