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
PMN K201860 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base	2021-02-19
GUDID 05712821007384 Elos Medtech Pinol A/S	Scan Body	2020-12-21
GUDID 05712821007377 Elos Medtech Pinol A/S	Scan Body	2020-12-21
GUDID 05712821007360 Elos Medtech Pinol A/S	Scan Body	2020-12-21
GUDID 05712821007391 Elos Medtech Pinol A/S	Torque Wrench, TW	2020-09-23
GUDID 05712821007353 Elos Medtech Pinol A/S	Torque Wrench 70Ncm	2020-09-23
GUDID 05712821007346 Elos Medtech Pinol A/S	Torque Wrench 45Ncm	2020-09-23
GUDID 05712821007339 Elos Medtech Pinol A/S	Torque Wrench	2020-09-23
GUDID 05712821006769 Elos Medtech Pinol A/S	H-TIRW STANDARD 4mm SQUARE ADAPTER	2020-07-23
GUDID 05712821006738 Elos Medtech Pinol A/S	Z-HIGH TORQUE INDICATING RATCHET WRENCH	2020-07-23
GUDID 05712821006646 Elos Medtech Pinol A/S	L-TIRW SHORT ISO 1797 ADAPTER	2020-07-23
GUDID 05712821006639 Elos Medtech Pinol A/S	L-TIRW STANDARD ISO 1797 ADAPTER	2020-07-23
GUDID 05712821006578 Elos Medtech Pinol A/S	HIGH TORQUE INDICATING RATCHET WRENCH	2020-07-23
GUDID 05712821006561 Elos Medtech Pinol A/S	LOW TORQUE INDICATING RATCHET WRENCH	2020-07-23
GUDID 05712821006462 Elos Medtech Pinol A/S	ISO Adapter For Multi wrench	2020-07-23
GUDID 05712821006455 Elos Medtech Pinol A/S	Square Adapter For Multi wrench	2020-07-23
GUDID 05712821006448 Elos Medtech Pinol A/S	Multi wrench with ISO adapter	2020-07-23
GUDID 05712821005359 Elos Medtech Pinol A/S	Elos Driver	2020-07-23
GUDID 05712821005342 Elos Medtech Pinol A/S	Elos Driver	2020-07-23
GUDID 05712821005335 Elos Medtech Pinol A/S	Elos Driver	2020-07-23
GUDID 05712821005328 Elos Medtech Pinol A/S	Elos Driver	2020-07-23
GUDID 05712821005311 Elos Medtech Pinol A/S	Elos Driver	2020-07-23
GUDID 05712821005304 Elos Medtech Pinol A/S	Elos Driver	2020-07-23
GUDID 05712821005298 Elos Medtech Pinol A/S	Elos Driver	2020-07-23
GUDID 05712821005281 Elos Medtech Pinol A/S	Elos Driver	2020-07-23
GUDID 05712821005274 Elos Medtech Pinol A/S	Elos Driver	2020-07-23
GUDID 05712821002679 Elos Medtech Pinol A/S	Abutment Blank	2020-04-08
GUDID 05712821002655 Elos Medtech Pinol A/S	Abutment Blank	2020-04-08
GUDID 05712821002594 Elos Medtech Pinol A/S	Abutment Blank	2020-04-08
GUDID 05712821002518 Elos Medtech Pinol A/S	Abutment Blank	2020-04-08
GUDID 05712821002495 Elos Medtech Pinol A/S	Abutment Blank	2020-04-08
GUDID 05712821002464 Elos Medtech Pinol A/S	Abutment Blank	2020-04-08
GUDID 05712821002440 Elos Medtech Pinol A/S	Abutment Blank	2020-04-08
GUDID 05712821002426 Elos Medtech Pinol A/S	Abutment Blank	2020-04-08
GUDID 05712821002402 Elos Medtech Pinol A/S	Abutment Blank	2020-04-08
GUDID 05712821002358 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002334 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002327 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002310 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002303 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002297 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002280 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002266 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002228 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002211 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002204 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002198 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002181 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002167 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002150 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002143 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002136 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002129 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002112 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002105 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw	2020-04-08
GUDID 05712821002099 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001986 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001979 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001962 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001955 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001948 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001917 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001900 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001894 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001863 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001856 Elos Medtech Pinol A/S	Elos Prosthetic Screw	2020-04-08
GUDID 05712821001283 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001276 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001269 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001252 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001245 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001238 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001221 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001214 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001191 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001184 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001177 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001160 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001153 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001146 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001108 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001092 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821001085 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Non-Engaging	2020-04-08
GUDID 05712821000545 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000538 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000521 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000514 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000507 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000491 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000484 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000477 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000439 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000422 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000415 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000408 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000392 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000385 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000378 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000361 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000354 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
GUDID 05712821000347 Elos Medtech Pinol A/S	Elos Accurate® Hybrid Base™ Engaging	2020-04-08
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