Planmeca Oy

FDA Filings

This page includes the latest FDA filings for Planmeca Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8030876
• FEI Number: 1000207287
• Name: Ed Mcdonough
• Owner & Operator: Planmeca Oy
• Contact Address: Asentajankatu 6 ; Helsinki FI-ES Etela-Suomen laani 00880 FI
• Official Correspondent:
  • Lars K Moring
  • 358-20-7795500-x
• US Agent:
  • Ed Mcdonough
  • Planmeca U.S.A. Inc.
  • 630 5292300
  • ed.mcdonough@planmecausa.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2600 Forbs Ave. ; Hoffman Est, IL 60192 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 2183536
• FEI Number: 1421092
• Name: Planmeca U.S.A. Inc.
• Owner & Operator: Planmeca Oy
• Contact Address: Asentajankatu 6 ; Helsinki FI-ES Etela-Suomen laani 00880 FI
• Official Correspondent:
  • Lars K Moring
  • 358-20-7795500-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2600 Forbs Ave. ; Hoffman Est, IL 60192 US

FDA Filings

Device Company	Device	Date
GUDID 06430035420988 Planmeca Oy	Planmeca Viso 30048120, 30035196, 30016794, 30054720, 30064043,	2025-09-15
GUDID 06430035420995 Planmeca Oy	Planmeca Viso 30048121,30016793, 30064269	2025-09-10
GUDID 06430035420599 Planmeca Oy	Planmeca Romexis 10041546	2023-06-22
PMN K200572 Planmeca Oy	Planmeca Romexis	2020-12-02
GUDID 06430035420612 Planmeca Oy	Planmeca Compact 30021331, 30021332	2019-11-06
GUDID 06430035420605 Planmeca Oy	Planmeca Viso 30016183	2019-03-14
GUDID 06430035420575 Planmeca Oy	Planmeca Compact 30013450, 30015629, 30015630, 30015632, 30015633	2019-02-04
NRD Ed Mcdonough [Planmeca Oy]	Planmeca Somia	2018-11-02
GUDID 06430035420551 Planmeca Oy	Planmeca Viso 30004941	2018-10-22
PMN K181576 | OAS Ed Mcdonough [Planmeca Oy]	Planmeca Viso	2018-09-18
PMN K181576 Planmeca Oy	Planmeca Viso	2018-09-13
GUDID 06430035420490 Planmeca Oy	Planmeca ProMax 30003112	2018-07-06
GUDID 06430035420483 Planmeca Oy	Planmeca ProMax 30003113	2018-07-06
GUDID 06430035420476 Planmeca Oy	Planmeca ProMax 30003109	2018-07-06
GUDID 06430035420469 Planmeca Oy	Planmeca ProMax 30003110	2018-07-06
GUDID 06430035420452 Planmeca Oy	Planmeca ProMax 30003107	2018-07-06
GUDID 06430035420445 Planmeca Oy	Planmeca ProMax 30003108	2018-07-06
GUDID 06430035420438 Planmeca Oy	Planmeca Compact 10031950, 10031951, 10031952, 10031953, 10039745,	2018-07-06
GUDID 06430035420407 Planmeca Oy	Planmeca ProMax 10032801	2018-07-06
GUDID 06430035420377 Planmeca Oy	Planmeca ProMax 10032016	2018-07-06
GUDID 06430035420346 Planmeca Oy	Planmeca ProMax 10020018	2018-07-06
GUDID 06430035420322 Planmeca Oy	Planmeca ProOne 10012010	2018-07-06
GUDID 06430035420315 Planmeca Oy	Planmeca ProMax 10019566	2018-07-06
GUDID 06430035420308 Planmeca Oy	Planmeca ProSensor 10037245	2018-07-06
GUDID 06430035420292 Planmeca Oy	Planmeca ProMax 10030688	2018-07-06
GUDID 06430035420254 Planmeca Oy	Planmeca Romexis	2018-07-06
GUDID 06430035420247 Planmeca Oy	Planmeca SingLED 10020815	2018-07-06
GUDID 06430035420162 Planmeca Oy	Planmeca Chair 10026000	2018-07-06
GUDID 06430035420100 Planmeca Oy	Planmeca Sovereign 10032746, 10032747	2018-07-06
GUDID 06430035420544 Planmeca Oy	Planmeca Solanna 30006329; 30009016	2018-03-29
GUDID 06430035420513 Planmeca Oy	Planmeca ProMax 30003115	2018-03-29
GUDID 06430035420506 Planmeca Oy	Planmeca ProMax 30003114	2018-03-29
GUDID 06430035420360 Planmeca Oy	Planmeca Intra 10029551	2018-03-29
GUDID 06430035420353 Planmeca Oy	Planmeca ProMax 10020019	2018-03-29
PMN K171385 | LLZ Ed Mcdonough [Planmeca Oy]	Planmeca Romexis	2017-12-05
PMN K171385 Planmeca Oy	Planmeca Romexis	2017-11-14
EAZ Ed Mcdonough [Planmeca Oy]	Planmeca Solanna	2017-08-28
PMN K923534 | KLC Ed Mcdonough [Planmeca Oy]	Planmeca Chair	2017-05-05
PMN K160506 PLANMECA OY	Planmeca ProMax 3D Max, Planmeca Maximity	2016-05-20
NOF Ed Mcdonough [Planmeca Oy]	PlanScan Lab, PlanMill 50, PlanCAD Premium	2015-09-07
PMN K140713 | LLZ Ed Mcdonough [Planmeca Oy]	Planmeca Romexis	2014-09-09
PMN K140713 PLANMECA OY	PLANMECA ROMEXIS	2014-06-16
PMN K103689 | MUH Ed Mcdonough [Planmeca Oy]	Planmeca ProMax 3D Mid	2011-03-29
PMN K103689 PLANMECA OY	PLANMECA PROMAX 3D MID	2011-03-17
PMN K093590 | MUH Ed Mcdonough [Planmeca Oy]	Planmeca ProMax 3D Max	2010-06-04
PMN K093590 PLANMECA OY	PLANMECA PROMAX 3D MAX	2010-05-12
PMN K091197 | EHD Ed Mcdonough [Planmeca Oy]	Planmeca ProSensor	2009-11-12
PMN K091197 PLANMECA OY	PLANMECA PROSENSOR	2009-07-29
PMN K081699 | EIA Ed Mcdonough [Planmeca Oy]	Planmeca Sovereign	2009-03-20
PMN K081699 | EIA Ed Mcdonough [Planmeca Oy]	Planmeca Sovereign Side	2009-03-20
PMN K081699 | EIA Ed Mcdonough [Planmeca Oy]	Planmeca Sovereign Reach	2009-03-20
PMN K081699 | EIA Ed Mcdonough [Planmeca Oy]	Planmeca Sovereign Classy	2009-03-20
PMN K961420 | EIA Ed Mcdonough [Planmeca Oy]	Planmeca Compact	2007-12-05
PMN K955429 | EHD Ed Mcdonough [Planmeca Oy]	Planmeca Intra	2007-12-05
PMN K923462 | EAZ Ed Mcdonough [Planmeca Oy]	Planmeca SingLed	2007-12-05
PMN K923462 | EAZ Ed Mcdonough [Planmeca Oy]	Planmeca Delight	2007-12-05
PMN K072244 | MUH Ed Mcdonough [Planmeca Oy]	Planmeca ProOne	2007-12-05
PMN K060328 | MUH Ed Mcdonough [Planmeca Oy]	Planmeca ProMax 3Ds	2007-12-05
PMN K060328 | MUH Ed Mcdonough [Planmeca Oy]	Planmeca ProMax 3D	2007-12-05
PMN K051464 | MUH Ed Mcdonough [Planmeca Oy]	Planmeca ProMax with DEC	2007-12-05
PMN K051464 | EHD Ed Mcdonough [Planmeca Oy]	Planmeca ProMax with DEC	2007-12-05
PMN K011619 | EHD Ed Mcdonough [Planmeca Oy]	Planmeca ProMax	2007-12-05
PMN K000771 | EHD Ed Mcdonough [Planmeca Oy]	Planmeca Dimax	2007-12-05
PMN K000163 | EHD Ed Mcdonough [Planmeca Oy]	Planmeca Proline XC	2007-12-05
PMN K000163 | EHD Ed Mcdonough [Planmeca Oy]	Planmeca Proline EC	2007-12-05
PMN K000163 | EHD Ed Mcdonough [Planmeca Oy]	Planmeca Proline CC	2007-12-05
PMN K072244 PLANMECA OY	PLANMECA PROONE	2007-09-21
PMN K060328 PLANMECA OY	PLANMECA PROMAX 3D	2006-03-15
PMN K051464 PLANMECA OY	PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)	2005-06-24
PMN K011619 PLANMECA OY	PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT	2001-06-29
PMN K000771 PLANMECA OY	DIMAX 2	2000-05-03
PMN K000428 PLANMECA OY	DIXI 2	2000-04-28
PMN K000163 PLANMECA OY	PM 2002 PROLINE/AEC	2000-04-18
PMN K000454 PLANMECA OY	DIMEX 2	2000-03-31
PMN K984013 PLANMECA OY	PLANMECA INTRACAM STATION	1999-01-26
PMN K980581 PLANMECA OY	PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM	1998-04-17
PMN K970812 PLANMECA OY	PM 2002 CC PROLINE	1997-08-05
PMN K972033 PLANMECA OY	PLANMECA INTRACAM	1997-06-20
PMN K970975 PLANMECA OY	PROSTYLE INTRA	1997-04-01
PMN K970263 PLANMECA OY	PM 2002 CC PROLINE	1997-02-26
PMN K963209 PLANMECA OY	PROSTYLE COMPACT	1996-10-24
PMN K961420 PLANMECA OY	PROSTYLE COMPACT	1996-09-10
PMN K955429 PLANMECA OY	PROSTYLE INTRA	1995-12-11
PMN K952763 PLANMECA OY	PANORAMIC X-RAY UNIT (MODIFICATION)	1995-10-07
PMN K934063 PLANMECA OY	PANORAMIC X-RAY UNITS, MODIFICATION	1993-12-15

Related Finance Registrations

NCAGE Code	S5126	PLANMECA OY
NCAGE Code	A038G	PLANMECA OY
CAGE Code	A038G	PLANMECA OY
CAGE Code	S5126	PLANMECA OY

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092999384	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES	36 PKG
2020091665757	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES, DENTAL UNITS	141 PKG
2020091665757	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES, DENTAL UNITS	141 PKG
2020091665756	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES	91 PKG
2020091665756	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES	91 PKG
2020091574192	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES	91 PKG
2020091574192	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES	91 PKG
2020091574193	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES, DENTAL UNITS	141 PKG
2020091574193	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES, DENTAL UNITS	141 PKG
20200909118105	Anvers,Belgium -> Norfolk, Virginia	X RAY APP	25 PKG
20200811117660	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES	42 PKG
20200811117659	Anvers,Belgium -> Norfolk, Virginia	X RAY APP FOR DENTAL USES	53 PKG