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 05712821013057 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-CBA34-1	2025-01-30
GUDID 05712821013040 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-CAS50-1	2025-01-30
GUDID 05712821013033 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-CAS43-1	2025-01-30
GUDID 05712821013026 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-CAS38-1	2025-01-30
GUDID 05712821013019 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-CAS33-1	2025-01-30
GUDID 05712821013002 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-BCE41-1	2025-01-30
GUDID 05712821012999 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-BCE34-1	2025-01-30
GUDID 05712821012982 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ZSV57-1	2025-01-30
GUDID 05712821012975 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ZSV45-1	2025-01-30
GUDID 05712821012968 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-ZSV35-1	2025-01-30
GUDID 05712821012951 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-NGA35-1	2025-01-30
GUDID 05712821012944 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-NGM45-1	2025-01-30
GUDID 05712821012937 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-HET45-1	2025-01-30
GUDID 05712821012920 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-HET35-1	2025-01-30
GUDID 05712821012876 Elos Medtech Pinol A/S	Elos Accurate® Scan Body 22 SB-SBX45-1	2025-01-30
GUDID 05712821014603 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (XS) low 68012590	2024-12-20
GUDID 05712821014580 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (XL) high 68012599	2024-12-20
GUDID 05712821014573 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (XL) low 68012598	2024-12-20
GUDID 05712821014566 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (L) high 68012597	2024-12-20
GUDID 05712821014559 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (L) low 68012596	2024-12-20
GUDID 05712821014542 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (M) high 68012595	2024-12-20
GUDID 05712821014535 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (M) low 68012594	2024-12-20
GUDID 05712821014528 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (S) high 68012593	2024-12-20
GUDID 05712821014511 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (S) low 68012592	2024-12-20
GUDID 05712821014504 Elos Medtech Pinol A/S	TitaniumBase EV ASA Abutment Screw (XS) high 68012591	2024-12-20
GUDID 05712821014481 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XL) 4mm NI 68012589	2024-12-20
GUDID 05712821014474 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XL) 3mm NI 68012588	2024-12-20
GUDID 05712821014467 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XL) 2mm NI 68012587	2024-12-20
GUDID 05712821014450 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XL) 1mm NI 68012586	2024-12-20
GUDID 05712821014443 Elos Medtech Pinol A/S	TitaniumBase EV ASA (L) 4mm NI 68012585	2024-12-20
GUDID 05712821014436 Elos Medtech Pinol A/S	TitaniumBase EV ASA (L) 3mm NI 68012584	2024-12-20
GUDID 05712821014429 Elos Medtech Pinol A/S	TitaniumBase EV ASA (L) 2mm NI 68012583	2024-12-20
GUDID 05712821014412 Elos Medtech Pinol A/S	TitaniumBase EV ASA (L) 1mm NI 68012582	2024-12-20
GUDID 05712821014405 Elos Medtech Pinol A/S	TitaniumBase EV ASA (M) 4mm NI 68012581	2024-12-20
GUDID 05712821014399 Elos Medtech Pinol A/S	TitaniumBase EV ASA (M) 3mm NI 68012580	2024-12-20
GUDID 05712821014382 Elos Medtech Pinol A/S	TitaniumBase EV ASA (M) 2mm NI 68012579	2024-12-20
GUDID 05712821014375 Elos Medtech Pinol A/S	TitaniumBase EV ASA (M) 1mm NI 68012578	2024-12-20
GUDID 05712821014368 Elos Medtech Pinol A/S	TitaniumBase EV ASA (S) 4mm NI 68012577	2024-12-20
GUDID 05712821014351 Elos Medtech Pinol A/S	TitaniumBase EV ASA (S) 3mm NI 68012576	2024-12-20
GUDID 05712821014344 Elos Medtech Pinol A/S	TitaniumBase EV ASA (S) 2mm NI 68012575	2024-12-20
GUDID 05712821014337 Elos Medtech Pinol A/S	TitaniumBase EV ASA (S) 1mm NI 68012574	2024-12-20
GUDID 05712821014320 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XS) 4mm NI 68012573	2024-12-20
GUDID 05712821014313 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XS) 3mm NI 68012572	2024-12-20
GUDID 05712821014306 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XS) 2mm NI 68012571	2024-12-20
GUDID 05712821014290 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XS) 1mm NI 68012570	2024-12-20
GUDID 05712821014283 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XL) 4mm 68012569	2024-12-20
GUDID 05712821014276 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XL) 3mm 68012568	2024-12-20
GUDID 05712821014269 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XL) 2mm 68012567	2024-12-20
GUDID 05712821014252 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XL) 1mm 68012566	2024-12-20
GUDID 05712821014245 Elos Medtech Pinol A/S	TitaniumBase EV ASA (L) 4mm 68012565	2024-12-20
GUDID 05712821014238 Elos Medtech Pinol A/S	TitaniumBase EV ASA (L) 3mm 68012564	2024-12-20
GUDID 05712821014221 Elos Medtech Pinol A/S	TitaniumBase EV ASA (L) 2mm 68012563	2024-12-20
GUDID 05712821014214 Elos Medtech Pinol A/S	TitaniumBase EV ASA (L) 1mm 68012562	2024-12-20
GUDID 05712821014207 Elos Medtech Pinol A/S	TitaniumBase EV ASA (M) 4mm 68012561	2024-12-20
GUDID 05712821014191 Elos Medtech Pinol A/S	TitaniumBase EV ASA (M) 3mm 68012560	2024-12-20
GUDID 05712821014184 Elos Medtech Pinol A/S	TitaniumBase EV ASA (M) 2mm 68012559	2024-12-20
GUDID 05712821014177 Elos Medtech Pinol A/S	TitaniumBase EV ASA (M) 1mm 68012558	2024-12-20
GUDID 05712821014160 Elos Medtech Pinol A/S	TitaniumBase EV ASA (S) 4mm 68012557	2024-12-20
GUDID 05712821014153 Elos Medtech Pinol A/S	TitaniumBase EV ASA (S) 3mm 68012556	2024-12-20
GUDID 05712821014146 Elos Medtech Pinol A/S	TitaniumBase EV ASA (S) 2mm 68012555	2024-12-20
GUDID 05712821014139 Elos Medtech Pinol A/S	TitaniumBase EV ASA (S) 1mm 68012554	2024-12-20
GUDID 05712821014122 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XS) 4mm 68012553	2024-12-20
GUDID 05712821014115 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XS) 3mm 68012552	2024-12-20
GUDID 05712821014108 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XS) 2mm 68012551	2024-12-20
GUDID 05712821014092 Elos Medtech Pinol A/S	TitaniumBase EV ASA (XS) 1mm 68012550	2024-12-20
GUDID 05712821014665 Elos Medtech Pinol A/S	MultiBase ScanBody 68020522	2024-12-03
GUDID 05712821014658 Elos Medtech Pinol A/S	ScanBody EV (XL) 68020521	2024-12-03
GUDID 05712821014641 Elos Medtech Pinol A/S	ScanBody EV (L) 68020520	2024-12-03
GUDID 05712821014634 Elos Medtech Pinol A/S	ScanBody EV (M) 68020519	2024-12-03
GUDID 05712821014627 Elos Medtech Pinol A/S	ScanBody EV (S) 68020518	2024-12-03
GUDID 05712821014610 Elos Medtech Pinol A/S	ScanBody EV (XS) 68020517	2024-12-03
GUDID 05712821014061 Elos Medtech Pinol A/S	X-Nav FastMap Scan Body XNAC40	2024-10-21
GUDID 05712821014054 Elos Medtech Pinol A/S	X-Nav FastMap Scan Body XDBA40	2024-10-21
GUDID 05712821013972 Elos Medtech Pinol A/S	X-Nav FastMap Scan Body XNGA35	2024-10-21
GUDID 05712821013965 Elos Medtech Pinol A/S	X-Nav FastMap Scan Body XCBA43	2024-10-21
GUDID 05712821013958 Elos Medtech Pinol A/S	X-Nav FastMap Scan Body XATU45	2024-10-21
GUDID 05712821013941 Elos Medtech Pinol A/S	X-Nav FastMap Scan Body XATU20	2024-10-21
GUDID 05712821013934 Elos Medtech Pinol A/S	X-Nav FastMap Scan Body XAUE33	2024-10-21
GUDID 05712821013927 Elos Medtech Pinol A/S	X-Nav FastMap Scan Body XSSA46	2024-10-21
GUDID 05712821013910 Elos Medtech Pinol A/S	X-Nav FastMap Scan Body XSSA35	2024-10-21
GUDID 05712821013422 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-ATO30-1	2024-09-30
GUDID 05712821013415 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-ATE30-1	2024-09-30
GUDID 05712821012890 Elos Medtech Pinol A/S	Elos Accurate Pre-Milled Blank PMB-SBX45-1	2024-09-30
GUDID 05712821012036 Elos Medtech Pinol A/S	CORiTEC Prosthetic Screw CAS-ATOM148POS	2024-09-30
GUDID 05712821011992 Elos Medtech Pinol A/S	CORiTEC Prosthetic Screw CAS-ATEM148POS	2024-09-30
GUDID 05712821011572 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-ATO30-1	2024-09-30
GUDID 05712821011527 Elos Medtech Pinol A/S	CORiTEC preMill CPMB-ATE30-1	2024-09-30
GUDID 05712821011282 Elos Medtech Pinol A/S	Elos Prosthetic Screw AS-SBXM1606POS	2024-09-30
GUDID 05712821011275 Elos Medtech Pinol A/S	Elos Accurate® Hexalobular Prosthetic Screw AS-SBXM1606A-1	2024-09-30
GUDID 05712821011251 Elos Medtech Pinol A/S	Abutment Blank AB-SBX451213	2024-09-30
GUDID 05712821011244 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base Engaging HBN-SBX45H-1	2024-09-30
GUDID 05712821011237 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base Engaging HBN-SBX45-1	2024-09-30
GUDID 05712821011220 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base H Engaging HBE-SBX45H-1	2024-09-30
GUDID 05712821002471 Elos Medtech Pinol A/S	Abutment Blank AB-ATO301010	2024-09-30
GUDID 05712821002389 Elos Medtech Pinol A/S	Abutment Blank AB-ATE301010	2024-09-30
GUDID 05712821011213 Elos Medtech Pinol A/S	Elos Accurate Hybrid Base Engaging HBE-SBX45-1	2024-09-26
GUDID 05712821013804 Elos Medtech Pinol A/S	Analog for Printed Model PS IMPDA 4,1 60795	2024-08-07
GUDID 05712821013798 Elos Medtech Pinol A/S	Analog for Printed Model PS IMPDA 3,75 60794	2024-08-07
GUDID 05712821013781 Elos Medtech Pinol A/S	Analog for Printed Model PS IMPDA 3,25 60793	2024-08-07
GUDID 05712821013774 Elos Medtech Pinol A/S	Analog for Printed Model PS IMPDA 3,0 60792	2024-08-07
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