Elos Medtech Pinol A S

FDA Filings

This page includes the latest FDA filings for Elos Medtech Pinol A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007689689
• FEI Number: 3007689689
• Name: ELOS MEDTECH PINOL A/S
• Owner & Operator: Elos Medtech Pinol A/S
• Contact Address: Engvej 33 ; Goerloese DK-84 Region Hovedstaden DK3330 DK
• Official Correspondent:
  • Tina Friis Poulsen
  • 45-48-216400-x
• US Agent:
  • Jodie Gilmore
  • Elos Medtech Onyx LCC
  • 901 3236699
  • Jodie.Gilmore@elosmedtech.com
• Importing Logistics Registration:
  • Importer: Broadway Dental
  • Address: 5255 South 4015 west ; Taylorsville, UT 84118 UNITED STATES
• Importing Logistics Registration:
  • Importer: Imagine Milling
  • Address: 1890 Preston White Dr. Ste 103 ; Reston, VA 20191 UNITED STATES
• Importing Logistics Registration:
  • Importer: Sunrise Dental Laboratory
  • Address: 32371 Yucaipa Blvd. ; Yucaipa, CA 92399 UNITED STATES
• Importing Logistics Registration:
  • Importer: TruCrown
  • Address: 21150 Peters road ; Saegertown, PA 16433 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Engvej 33 ; Goerloese Region Hovedstaden, DK3330 DK
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 05712821013705 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 68020510	2024-05-15
GUDID 05712821013620 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 68020504	2024-05-15
GUDID 05712821013613 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 68020501	2024-05-15
GUDID 05712821013606 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 68020500	2024-05-15
GUDID 05712821013354 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-BCE60-1	2024-04-25
GUDID 05712821013347 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-BCE50-1	2024-04-25
GUDID 05712821013330 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-BCE41-1	2024-04-25
GUDID 05712821013323 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-BCE34-1	2024-04-25
GUDID 05712821011633 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-BCE60-1	2024-04-25
GUDID 05712821011626 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-BCE50-1	2024-04-25
GUDID 05712821011619 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-BCE41-1	2024-04-25
GUDID 05712821011602 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-BCE34-1	2024-04-25
GUDID 05712821007827 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Engaging HBE-BCE60H-1	2024-04-25
GUDID 05712821007810 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Engaging HBE-BCE50H-1	2024-04-25
GUDID 05712821007803 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Engaging HBE-BCE41H-1	2024-04-25
GUDID 05712821007797 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Engaging HBE-BCE34H-1	2024-04-25
GUDID 05712821002570 Elos Medtech Pinol A/S	Abutment Blank AB-BCE501213	2024-04-25
GUDID 05712821002556 Elos Medtech Pinol A/S	Abutment Blank AB-BCE411213	2024-04-25
GUDID 05712821002532 Elos Medtech Pinol A/S	Abutment Blank AB-BCE341213	2024-04-25
GUDID 05712821000330 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Engaging HBE-BCE60-1	2024-04-25
GUDID 05712821000323 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Engaging HBE-BCE50-1	2024-04-25
GUDID 05712821000316 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Engaging HBE-BCE41-1	2024-04-25
GUDID 05712821000309 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Engaging HBE-BCE34-1	2024-04-25
GUDID 05712821013767 Elos Medtech Pinol A/S	CORiTEC Prosthetic Screw CAS-BCEM168NCPOS	2024-04-24
GUDID 05712821013750 Elos Medtech Pinol A/S	Elos Prosthetic Screw AS-BCEM168NCPOS	2024-04-24
GUDID 05712821013743 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw AS-BCEM1608NCA-1	2024-04-24
GUDID 05712821013699 Elos Medtech Pinol A/S	Elos Accurate® Prosthetic Screwdriver 34mm 68020509	2024-04-15
GUDID 05712821013682 Elos Medtech Pinol A/S	Elos Accurate® Prosthetic Screwdriver 26mm 68020508	2024-04-15
GUDID 05712821013675 Elos Medtech Pinol A/S	Elos Accurate® Prosthetic Screwdriver 18mm 68020507	2024-04-15
GUDID 05712821013668 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw 68020506	2024-04-15
GUDID 05712821013651 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw 68020503	2024-04-15
GUDID 05712821013644 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Non-Engaging 68020505	2024-04-15
GUDID 05712821013637 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Non-Engaging 68020502	2024-04-15
GUDID 05712821010513 Elos Medtech Pinol A/S	Elos Prosthetic Screw AS-NGMM1610POS	2024-02-19
GUDID 05712821010506 Elos Medtech Pinol A/S	Elos Prosthetic Screw AS-HETM2008POS	2024-02-19
GUDID 05712821010490 Elos Medtech Pinol A/S	Elos Prosthetic Screw AS-HETM1610POS	2024-02-19
GUDID 05712821009609 Elos Medtech Pinol A/S	Abutment Blank AB-NGM451213	2024-02-19
GUDID 05712821009586 Elos Medtech Pinol A/S	Abutment Blank AB-HET451213	2024-02-19
GUDID 05712821009562 Elos Medtech Pinol A/S	Abutment Blank AB-HET351213	2024-02-19
GUDID 05712821003157 Elos Medtech Pinol A/S	Abutment Blank AB-ZSV551213O	2024-02-19
GUDID 05712821003133 Elos Medtech Pinol A/S	Abutment Blank AB-ZSV451213O	2024-02-19
GUDID 05712821003119 Elos Medtech Pinol A/S	Abutment Blank AB-ZSV351213O	2024-02-19
GUDID 05712821003096 Elos Medtech Pinol A/S	Abutment Blank AB-SSY651213	2024-02-19
GUDID 05712821003072 Elos Medtech Pinol A/S	Abutment Blank AB-SSY481213	2024-02-19
GUDID 05712821002013 Elos Medtech Pinol A/S	Elos Prosthetic Screw AS-ZSVM1808POS	2024-02-19
GUDID 05712821002006 Elos Medtech Pinol A/S	Elos Prosthetic Screw AS-SSYM207POS	2024-02-19
GUDID 05712821013538 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-HET45-1	2024-02-16
GUDID 05712821013521 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-HET35-1	2024-02-16
GUDID 05712821013514 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-NGM45-1	2024-02-16
GUDID 05712821013408 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-ZSV57-1	2024-02-16
GUDID 05712821013392 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-ZSV45-1	2024-02-16
GUDID 05712821013385 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-ZSV35-1	2024-02-16
GUDID 05712821013378 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-SSY65-1	2024-02-16
GUDID 05712821013361 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-SSY48-1	2024-02-16
GUDID 05712821011985 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-ZSV57-1	2024-02-16
GUDID 05712821011978 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-ZSV45-1	2024-02-16
GUDID 05712821011961 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-ZSV35-1	2024-02-16
GUDID 05712821011954 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-SSY65-1	2024-02-16
GUDID 05712821011947 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-SSY48-1	2024-02-16
GUDID 05712821011916 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-NGM45-1	2024-02-16
GUDID 05712821011824 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-HET45-1	2024-02-16
GUDID 05712821011817 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-HET35-1	2024-02-16
GUDID 05712821013316 Elos Medtech Pinol A/S	CORiTEC Prosthetic Screw CAS-SBXM1606POS	2024-01-24
GUDID 05712821013309 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-SBX45-1	2024-01-24
GUDID 05712821011336 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-NBA43-1	2024-01-24
GUDID 05712821011329 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-NBA35-1	2024-01-24
GUDID 05712821010988 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-DBA40-1	2024-01-19
GUDID 05712821010933 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ATE48P-1	2024-01-19
GUDID 05712821010926 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ATE42P-1	2024-01-19
GUDID 05712821010902 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-BHI57-1	2024-01-19
GUDID 05712821010896 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-BHI45-1	2024-01-19
GUDID 05712821010889 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-BHI35-1	2024-01-19
GUDID 05712821010872 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-BHI30-1	2024-01-19
GUDID 05712821010865 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ATU45-1	2024-01-19
GUDID 05712821010858 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ATU20-1	2024-01-19
GUDID 05712821010841 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-SSY65-1	2024-01-19
GUDID 05712821010834 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-SSY48-1	2024-01-19
GUDID 05712821010827 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-SBO41-1	2024-01-19
GUDID 05712821010810 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-SBO33-1	2024-01-19
GUDID 05712821010803 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-SSA46-1	2024-01-19
GUDID 05712821010797 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-SSA35-1	2024-01-19
GUDID 05712821010773 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-AUE33-1	2024-01-19
GUDID 05712821010766 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ATO45-1	2024-01-19
GUDID 05712821010759 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ATO35-1	2024-01-19
GUDID 05712821010742 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ATO30-1	2024-01-19
GUDID 05712821011398 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-ATO45-1	2024-01-12
GUDID 05712821011381 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-ATO35-1	2024-01-12
GUDID 05712821011374 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-BRA51-1	2024-01-12
GUDID 05712821011367 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-BRA35-1	2024-01-12
GUDID 05712821011350 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-BRA41-1	2024-01-12
GUDID 05712821011343 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-NBA60-1	2024-01-12
GUDID 05712821011312 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-NBA30-1	2024-01-12
GUDID 05712821011305 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-NBR60-1	2024-01-12
GUDID 05712821011299 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-NBR50-1	2024-01-12
GUDID 05712821010322 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-ATE42-10	2024-01-12
GUDID 05712821010315 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-ATE36-10	2024-01-12
GUDID 05712821010308 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-SBO41-10	2024-01-12
GUDID 05712821010292 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-SBO33-10	2024-01-12
GUDID 05712821010285 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-NBA43-10	2024-01-12
GUDID 05712821010278 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-NBA35-10	2024-01-12
PMN K222044 Elos Medtech Pinol A/S	Elos Accurate Customized Abutment	2022-11-30
PMN K201860 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base	2021-02-19
PMN K192457 | NHA ELOS MEDTECH PINOL A/S	Elos Prosthetic Screw	2020-03-02
PMN K192457 | NHA ELOS MEDTECH PINOL A/S	Elos Accurate? Custom Ti Abut	2020-03-02
PMN K192457 | NHA ELOS MEDTECH PINOL A/S	Abutment Blank	2020-03-02
PMN K191919 | NHA ELOS MEDTECH PINOL A/S	Universal Base Non-Engaging	2020-03-02
PMN K191919 | NHA ELOS MEDTECH PINOL A/S	Elos Accurate? Hybrid Base? Non-Engaging	2020-03-02
PMN K191919 | NHA ELOS MEDTECH PINOL A/S	Elos Accurate? Hybrid Base? Engaging	2020-03-02
PMN K191919 | NHA ELOS MEDTECH PINOL A/S	Elos Accurate? Hexalobular Prosthetic Screw	2020-03-02
PMN K191890 | NHA ELOS MEDTECH PINOL A/S	Elos Prosthetic Screw	2020-03-02
PMN K191890 | NHA ELOS MEDTECH PINOL A/S	Elos Accurate? Custom Ti Abut	2020-03-02
PMN K191890 | NHA ELOS MEDTECH PINOL A/S	Abutment Blank	2020-03-02
PMN K191919 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base	2020-02-10
PMN K191890 Elos Medtech Pinol A/S	Elos Accurate Customized Abutment	2020-02-06
PMN K192457 Elos Medtech Pinol A/S	Elos Accurate Customized Abutment	2020-01-02
PMN K190299 | NHA ELOS MEDTECH PINOL A/S	Elos Prosthetic Screw	2019-10-24
PMN K190299 | NHA ELOS MEDTECH PINOL A/S	Elos Accurate? Custom Ti Abut	2019-10-24
PMN K190299 | NHA ELOS MEDTECH PINOL A/S	Abutment Blank	2019-10-24
PMN K171799 | NHA ELOS MEDTECH PINOL A/S	Elos Prosthetic Screw	2019-10-24
PMN K171799 | NHA ELOS MEDTECH PINOL A/S	Elos Accurate? Custom Ti Abut	2019-10-24
PMN K171799 | NHA ELOS MEDTECH PINOL A/S	Abutment Blank	2019-10-24
PMN K171799 | DZE ELOS MEDTECH PINOL A/S	Elos Prosthetic Screw	2019-10-24
PMN K171799 | DZE ELOS MEDTECH PINOL A/S	Elos Accurate? Custom Ti Abut	2019-10-24
PMN K171799 | DZE ELOS MEDTECH PINOL A/S	Abutment Blank	2019-10-24
PMN K190299 Elos Medtech Pinol A/S	Elos Accurate® Customized Abutment	2019-06-26
PMN K171799 Elos Medtech Pinol A/S	Elos Accurate Customized Abutment, Elos Prosthetic Screw	2018-01-15
PMN K112730 | NHA ELOS MEDTECH PINOL A/S	LDA SCREW SBL 4MM(D)	2016-02-09
PMN K112730 | NHA ELOS MEDTECH PINOL A/S	LDA SCREW SBL 3MM(D)	2016-02-09
PMN K110565 | NHA ELOS MEDTECH PINOL A/S	LDA SCREW NBR 4.3, 5.0, 6.0MM (D)	2011-09-15
PMN K110565 | NHA ELOS MEDTECH PINOL A/S	LDA SCREW NBR 3.5MM (D)	2011-09-15
PMN K971706 | NHA ELOS MEDTECH PINOL A/S	Handle for Machine Instruments	2010-12-15
PMN K952676 | DZE ELOS MEDTECH PINOL A/S	NobelReplace CC, Conical Connection, Branemark System, Replace Select, Abutment EsthetiCone, CeraOne, Procera, Nobel Pro	2010-12-15
PMN K993595 | DZE ELOS MEDTECH PINOL A/S	NobelReplace CC, Conical Connection, Branemark System, Replace Select, Abutment EsthetiCone, CeraOne, Procera, Nobel Pro	2010-12-12
PMN K990846 | DZI ELOS MEDTECH PINOL A/S	Nobel Replace, Nobel Active, Nobel Direct, Branemark System	2010-12-12
PMN K920452 | DZE ELOS MEDTECH PINOL A/S	Handle for Protection Analogs	2010-12-12
PMN K915733 | DZE ELOS MEDTECH PINOL A/S	NobelReplace CC, Conical Connection, Branemark System, Replace Select, Abutment EsthetiCone, CeraOne, Procera, Nobel Pro	2010-12-12
HXX ELOS MEDTECH PINOL A/S	Screwdriver	2010-11-27
HXC ELOS MEDTECH PINOL A/S	Nobel Replace, Branemark System	2010-11-27
NDP ELOS MEDTECH PINOL A/S	Torque wrench kit	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Torque Wrench	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Torque Wrench EV	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Torque Wrench EV Surgical Driver Handle	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Torque Wrench EV Restorative Driver Handle	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Torque Wrench EV Restorative Driver Handle Low	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Torque Wrench EV Restorative Driver Handle 4x4 Low	2009-04-16
NDP ELOS MEDTECH PINOL A/S	TSV Implant Digital Lab analog	2009-04-16
NDP ELOS MEDTECH PINOL A/S	TSV Implant Digital Lab analog Placement Tool	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Nobel Replace, Branemark System, Procera, Nobel Active	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Low Torque Indicating Rachet Wrench	2009-04-16
NDP ELOS MEDTECH PINOL A/S	High Torque Indicating Rachet Wrench	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Torque Wrench Kit	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Driver	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Scan Body	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Scan Body Kit	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Scan Body Driver	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Prosthetic Screwdriver	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Model Analog	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Hybrid Base? Non-Engaging	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Hexalobular Prosthetic Screw	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Analog for Printed Models	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Analog Tool	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Analog Pliers	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Analog Insertion Screw	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Elos Accurate? Analog Insertion Pin	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Drill Extender	2009-04-16
NDP ELOS MEDTECH PINOL A/S	Analog for Printed Model Neoss?	2009-04-16
NDP ELOS MEDTECH PINOL A/S	ADAPTER	2009-04-16