Dreve Dentamid G M B H

FDA Filings

This page includes the latest FDA filings for Dreve Dentamid G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1000486347
• FEI Number: 1000486347
• Name: Mike Kollar
• Owner & Operator: DREVE DENTAMID GMBH
• Contact Address: MAX-PLANCK-STRASSE 31 ; UNNA DE-NW Nordrhein-Westfalen 59423 DE
• US Agent:
  • Mike Kollar
  • DREVE AMERICA CORP.
  • 612 3238803
  • michael.kollar@dreve-america.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6477 City West Pkwy ; Eden Prairie, MN 55344 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID E239D38124US1 Dreve Dentamid GmbH	Plaquit D38124US	2024-04-24
GUDID E239D38123US1 Dreve Dentamid GmbH	Plaquit D38123US	2024-04-24
GUDID E239D38900US1 Dreve Dentamid GmbH	NanoVarnish D38900US	2023-10-24
GUDID E239D3530031 Dreve Dentamid GmbH	FotoDent® tray2 D353003	2023-04-26
GUDID E239D3530021 Dreve Dentamid GmbH	FotoDent® tray2 D353002	2023-04-26
GUDID E239D3530011 Dreve Dentamid GmbH	FotoDent® tray2 D353001	2023-04-26
GUDID E239D38135R1 Dreve Dentamid GmbH	Lightplast base plates D38135R	2022-12-13
GUDID E239D38135N1 Dreve Dentamid GmbH	Lightplast base plates D38135N	2022-12-13
GUDID E239D4248X91 Dreve Dentamid GmbH	Drufosoft® D4248X9	2022-08-29
GUDID E239D4248X81 Dreve Dentamid GmbH	Drufosoft® D4248X8	2022-08-29
GUDID E239D4248X71 Dreve Dentamid GmbH	Drufosoft® D4248X7	2022-08-29
GUDID E239D4248X6S1 Dreve Dentamid GmbH	Drufosoft® D4248X6S	2022-08-29
GUDID E239D4248X61 Dreve Dentamid GmbH	Drufosoft® D4248X6	2022-08-29
GUDID E239D4248X51 Dreve Dentamid GmbH	Drufosoft® D4248X5	2022-08-29
GUDID E239D4248X41 Dreve Dentamid GmbH	Drufosoft® D4248X4	2022-08-29
GUDID E239D4248X3Q1 Dreve Dentamid GmbH	Drufosoft® D4248X3Q	2022-08-29
GUDID E239D4248X31 Dreve Dentamid GmbH	Drufosoft® D4248X3	2022-08-29
GUDID E239D4248X26SQ1 Dreve Dentamid GmbH	Drufosoft® D4248X26SQ	2022-08-29
GUDID E239D4248X261 Dreve Dentamid GmbH	Drufosoft® D4248X26	2022-08-29
GUDID E239D4248X251 Dreve Dentamid GmbH	Drufosoft® D4248X25	2022-08-29
GUDID E239D4248X24S1 Dreve Dentamid GmbH	Drufosoft® D4248X24S	2022-08-29
GUDID E239D4248X241 Dreve Dentamid GmbH	Drufosoft® D4248X24	2022-08-29
GUDID E239D4248X23SQ1 Dreve Dentamid GmbH	Drufosoft® D4248X23SQ	2022-08-29
GUDID E239D4248X231 Dreve Dentamid GmbH	Drufosoft® D4248X23	2022-08-29
GUDID E239D4248X221 Dreve Dentamid GmbH	Drufosoft® D4248X22	2022-08-29
GUDID E239D4248X21SQ1 Dreve Dentamid GmbH	Drufosoft® D4248X21SQ	2022-08-29
GUDID E239D4248X211 Dreve Dentamid GmbH	Drufosoft® D4248X21	2022-08-29
GUDID E239D4248X21 Dreve Dentamid GmbH	Drufosoft® D4248X2	2022-08-29
GUDID E239D4248X201 Dreve Dentamid GmbH	Drufosoft® D4248X20	2022-08-29
GUDID E239D4248X191 Dreve Dentamid GmbH	Drufosoft® D4248X19	2022-08-29
GUDID E239D4248X18SQ1 Dreve Dentamid GmbH	Drufosoft® D4248X18SQ	2022-08-29
GUDID E239D4248X18S1 Dreve Dentamid GmbH	Drufosoft® D4248X18S	2022-08-29
GUDID E239D4248X181 Dreve Dentamid GmbH	Drufosoft® D4248X18	2022-08-29
GUDID E239D4248X17SQ1 Dreve Dentamid GmbH	Drufosoft® D4248X17SQ	2022-08-29
GUDID E239D4248X171 Dreve Dentamid GmbH	Drufosoft® D4248X17	2022-08-29
GUDID E239D42483X91 Dreve Dentamid GmbH	Drufosoft® D42483X9	2022-08-29
GUDID E239D42483X81 Dreve Dentamid GmbH	Drufosoft® D42483X8	2022-08-29
GUDID E239D42483X71 Dreve Dentamid GmbH	Drufosoft® D42483X7	2022-08-29
GUDID E239D42483X61 Dreve Dentamid GmbH	Drufosoft® D42483X6	2022-08-29
GUDID E239D42483X51 Dreve Dentamid GmbH	Drufosoft® D42483X5	2022-08-29
GUDID E239D42483X41 Dreve Dentamid GmbH	Drufosoft® D42483X4	2022-08-29
GUDID E239D42483X31 Dreve Dentamid GmbH	Drufosoft® D42483X3	2022-08-29
GUDID E239D42483X261 Dreve Dentamid GmbH	Drufosoft® D42483X26	2022-08-29
GUDID E239D42483X251 Dreve Dentamid GmbH	Drufosoft® D42483X25	2022-08-29
GUDID E239D42483X241 Dreve Dentamid GmbH	Drufosoft® D42483X24	2022-08-29
GUDID E239D42483X231 Dreve Dentamid GmbH	Drufosoft® D42483X23	2022-08-29
GUDID E239D42483X221 Dreve Dentamid GmbH	Drufosoft® D42483X22	2022-08-29
GUDID E239D42483X211 Dreve Dentamid GmbH	Drufosoft® D42483X21	2022-08-29
GUDID E239D42483X21 Dreve Dentamid GmbH	Drufosoft® D42483X2	2022-08-29
GUDID E239D42483X201 Dreve Dentamid GmbH	Drufosoft® D42483X20	2022-08-29
GUDID E239D42483X191 Dreve Dentamid GmbH	Drufosoft® D42483X19	2022-08-29
GUDID E239D42483X181 Dreve Dentamid GmbH	Drufosoft® D42483X18	2022-08-29
GUDID E239D42483X171 Dreve Dentamid GmbH	Drufosoft® D42483X17	2022-08-29
GUDID E239D42481SQ1 Dreve Dentamid GmbH	Drufosoft® D42481SQ	2022-08-29
GUDID E239D424811 Dreve Dentamid GmbH	Drufosoft® D42481	2022-08-29
GUDID E239D42481 Dreve Dentamid GmbH	Drufosoft® D4248	2022-08-29
GUDID E239D42472SQ1 Dreve Dentamid GmbH	Drufosoft® D42472SQ	2022-08-29
GUDID E239D424721 Dreve Dentamid GmbH	Drufosoft® D42472	2022-08-29
GUDID E239D42451SQ1 Dreve Dentamid GmbH	Drufosoft® D42451SQ	2022-08-29
GUDID E239D424511 Dreve Dentamid GmbH	Drufosoft® D42451	2022-08-29
GUDID E239D42451 Dreve Dentamid GmbH	Drufosoft® D4245	2022-08-29
GUDID E239D42374421 Dreve Dentamid GmbH	Drufolen H D4237442	2022-08-29
GUDID E239D423681S1 Dreve Dentamid GmbH	Drufolen H D423681S	2022-08-29
GUDID E239D4236811 Dreve Dentamid GmbH	Drufolen H D423681	2022-08-29
GUDID E239D4236411 Dreve Dentamid GmbH	Drufolen H D423641	2022-08-29
GUDID E239D4230Q1 Dreve Dentamid GmbH	Drufosoft® pro D4230Q	2022-08-29
GUDID E239D42301 Dreve Dentamid GmbH	Drufosoft® pro D4230	2022-08-29
GUDID E239D42251 Dreve Dentamid GmbH	Drufosoft® D4225	2022-08-29
GUDID E239D4200241 Dreve Dentamid GmbH	Biolon D420024	2022-08-29
GUDID E239D4200231 Dreve Dentamid GmbH	Biolon D420023	2022-08-29
GUDID E239D4200221 Dreve Dentamid GmbH	Biolon D420022	2022-08-29
GUDID E239D4200211 Dreve Dentamid GmbH	Biolon D420021	2022-08-29
GUDID E239D420020S1 Dreve Dentamid GmbH	Biolon D420020S	2022-08-29
GUDID E239D4200201 Dreve Dentamid GmbH	Biolon D420020	2022-08-29
GUDID E239D4200191 Dreve Dentamid GmbH	Biolon D420019	2022-08-29
GUDID E239D420018S1 Dreve Dentamid GmbH	Kombiplast D420018S	2022-08-29
GUDID E239D420018Q1 Dreve Dentamid GmbH	Kombiplast D420018Q	2022-08-29
GUDID E239D4200181 Dreve Dentamid GmbH	Kombiplast D420018	2022-08-29
GUDID E239D420017SQ1 Dreve Dentamid GmbH	Kombiplast D420017SQ	2022-08-29
GUDID E239D4200171 Dreve Dentamid GmbH	Kombiplast D420017	2022-08-29
GUDID E239D420016SQ1 Dreve Dentamid GmbH	Kombiplast D420016SQ	2022-08-29
GUDID E239D4200161 Dreve Dentamid GmbH	Kombiplast D420016	2022-08-29
GUDID E239D4200151 Dreve Dentamid GmbH	BioBleach® hart D420015	2022-08-29
GUDID E239D420012SQ1 Dreve Dentamid GmbH	Biolon D420012SQ	2022-08-29
GUDID E239D4200121 Dreve Dentamid GmbH	Biolon D420012	2022-08-29
GUDID E239D4200111 Dreve Dentamid GmbH	Biolon D420011	2022-08-29
GUDID E239D420010SQ1 Dreve Dentamid GmbH	Biolon D420010SQ	2022-08-29
GUDID E239D4200101 Dreve Dentamid GmbH	Biolon D420010	2022-08-29
GUDID E239D4200091 Dreve Dentamid GmbH	Biolon D420009	2022-08-29
GUDID E239D4200081 Dreve Dentamid GmbH	Biolon D420008	2022-08-29
GUDID E239D4200071 Dreve Dentamid GmbH	Biolon D420007	2022-08-29
GUDID E239D420006S1 Dreve Dentamid GmbH	Biolon D420006S	2022-08-29
GUDID E239D4200061 Dreve Dentamid GmbH	Biolon D420006	2022-08-29
GUDID E239D4200051 Dreve Dentamid GmbH	Biolon D420005	2022-08-29
GUDID E239D420004SQ1 Dreve Dentamid GmbH	Biolon D420004SQ	2022-08-29
GUDID E239D4200041 Dreve Dentamid GmbH	Biolon D420004	2022-08-29
GUDID E239D4200031 Dreve Dentamid GmbH	Biolon D420003	2022-08-29
GUDID E239D420002SQ1 Dreve Dentamid GmbH	Biolon D420002SQ	2022-08-29
GUDID E239D420002S1 Dreve Dentamid GmbH	Biolon D420002S	2022-08-29
GUDID E239D382341 Dreve Dentamid GmbH	Odontosil 2K Lack D38234	2022-08-29
PMN K200580 Dreve Dentamid GmbH	FotoDent Denture	2020-11-19
PMN K190571 | ELW Mike Kollar [DREVE DENTAMID GMBH]	StoneBite, StoneBite scan	2019-11-08
PMN K190571 Dreve Dentamid GmbH	StoneBite And StoneBite Scan	2019-11-07
PMN K171729 | EBG Mike Kollar [DREVE DENTAMID GMBH]	Fixtemp C&B	2018-06-15
PMN K171562 | ELW Mike Kollar [DREVE DENTAMID GMBH]	Dynax putty	2018-04-16
PMN K171562 | ELW Mike Kollar [DREVE DENTAMID GMBH]	Dynax mono	2018-04-16
PMN K171562 | ELW Mike Kollar [DREVE DENTAMID GMBH]	Dynax light	2018-04-16
PMN K171562 | ELW Mike Kollar [DREVE DENTAMID GMBH]	Dynax heavy body	2018-04-16
PMN K171562 | ELW Mike Kollar [DREVE DENTAMID GMBH]	Dynax clear	2018-04-16
PMN K171562 Dreve Dentamid GmbH	Dynax Clear, Dynax Putty, Dynax Heavy Body, Dynax Light, Dynax Mono	2018-04-13
PMN K162408 | EBD Mike Kollar [DREVE DENTAMID GMBH]	Plaquit	2018-04-09
PMN K162408 | EBD Mike Kollar [DREVE DENTAMID GMBH]	NanoVarnish	2018-04-09
PMN K162408 | EBD Mike Kollar [DREVE DENTAMID GMBH]	Lightpaint On Surface	2018-04-09
PMN K162408 DREVE DENTAMID GMBH	Nano Varnish, Plaquit, Lightpaint On Surface	2018-04-05
PMN K171729 Dreve Dentamid GmbH	Fixtemp C&B	2017-12-13
NDP Mike Kollar [DREVE DENTAMID GMBH]	Multiple	2015-06-16
NDP Mike Kollar [DREVE DENTAMID GMBH]	FotoDent Guide	2015-06-16
PMN K142446 | EMA Mike Kollar [DREVE DENTAMID GMBH]	FixTemp Cement	2015-06-12
EID Mike Kollar [DREVE DENTAMID GMBH]	Multiple	2015-06-12
PMN K102917 | EBG Mike Kollar [DREVE DENTAMID GMBH]	Multiple	2012-05-02
PMN K053427 | ELW Mike Kollar [DREVE DENTAMID GMBH]	Multiple	2012-05-02
EBH Mike Kollar [DREVE DENTAMID GMBH]	Multiple	2010-11-30
EBH Mike Kollar [DREVE DENTAMID GMBH]	FotoDent tray	2010-11-30
EBH Mike Kollar [DREVE DENTAMID GMBH]	FotoDent IBT	2010-11-30
KZN Mike Kollar [DREVE DENTAMID GMBH]	Multiple	2008-11-03
KMY Mike Kollar [DREVE DENTAMID GMBH]	Multiple	2004-12-28

Related Finance Registrations

NCAGE Code	C4777	DREVE DENTAMID GMBH
CAGE Code	C4777	DREVE DENTAMID GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092544020	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	GOODS MADE FROM SILICONE HTS 39100000	8 PKG
2020092544022	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	GOODS MADE FROM SILICONE HTS 39100000	22 PKG
2020092375294	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	DENTAL PRODUCTS	1 BOX
2020092273395	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	GOODS MADE FROM SILICONE HTS 39100000	22 PKG
2020092273393	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	GOODS MADE FROM SILICONE HTS 39100000	8 PKG
2020091968511	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	GOODS MADE FROM SILICONE HTS 39100000	22 PKG
2020091968509	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	GOODS MADE FROM SILICONE HTS 39100000	8 PKG
2020091859874	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	GOODS MADE FROM SILICONE HTS 39100000	8 PKG