Nusmile L T D

FDA Filings

This page includes the latest FDA filings for Nusmile L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006444232
FEI Number3006444232
NameNUSMILE, LTD
Owner & OperatorNUSMILE, LTD
Contact Address3315 W. 12th --
Houston TX 77008 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address3315 W 12th St
HOUSTON, TX 77008 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File one of each 31 mm (ZS1, ZS2, ZS3) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File one of each 25 mm (ZS1, ZS2, ZS3) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File one of each 21 mm (ZS1, ZS2, ZS3) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 31 mm (ZS1-ZS3) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 31 mm (ZS3) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 31 mm (ZS2) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 31 mm (ZS1) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1-ZS3) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS3) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS2) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS3) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS2) 2024-02-20
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1) 2024-02-20
NUSMILE, LTD.
Ultradent MTApex Sealer (Sample) 2024-02-07
NUSMILE, LTD.
Ultradent MTApex Sealer 2024-02-07
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper Gutta-Percha (ZS1) 2024-02-07
NUSMILE, LTD.
Avalon Biomed by Zarc SlimShaper Paper Point ZS1 2024-02-07
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z7) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z6) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z5) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z4) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z3) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z2) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z1) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 31mm (ZX-Z5) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z7) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z6) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z5) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z4) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z3) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z2) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z1) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 25mm (ZX-Z5) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z7) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z6) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z5) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z4) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z3) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z2) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z1) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 21mm (ZX-Z5) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 19mm (ZX) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z1-4) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z1-4) 2024-01-05
NUSMILE, LTD.
Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z1-4) 2024-01-05
NUSMILE, LTD.
NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU) 2023-12-08
NUSMILE, LTD.
Ultradent MTApex Sealer 2023-11-30
NUSMILE, LTD.
Avalon Biomed NeoSEALER Flo Professional Kit 4.4 g - SAMPLE 2023-11-30
NUSMILE, LTD.
Avalon Biomed NeoSEALER Flo 0.5 g Mini Kit, 10 Flex Flo Tips - SAMPLE 2023-11-30
NUSMILE, LTD.
Avalon Biomed NeoSEALER Flo 2.2 g w/ 20 Flex Flo Tips - SAMPLE 2023-11-30
NUSMILE, LTD.
Avalon Biomed NeoSEALER Flo Starter Kit 2.2 g - SAMPLE 2023-11-30
NUSMILE, LTD.
Avalon Biomed NeoSEALER Flo 2.2 g Refill Syringe - SAMPLE 2023-11-30
NUSMILE, LTD.
Avalon Biomed NeoSEALER Flo – 0.5g EU Mini Kit, 4 Flex Flo Tips - SAMPLE 2023-11-30
NUSMILE, LTD.
Avalon Biomed NeoSEALER Flo Starter Kit 2.2 g (Int'l) - SAMPLE 2023-11-30
NUSMILE, LTD.
Avalon Biomed NeoSEALER Flo – 0.5 g Int’l Mini Kit, 10 Flo Tips - SAMPLE 2023-11-30
NUSMILE, LTD.
NeoSEALER Flo Bioceramic Root Canal Sealer 2.2 g Refill Syringe - SAMPLE 2023-11-30
NUSMILE, LTD.
Zarc by AB NeoSEALER Flo 2.2 g Kit + 20 Flex Flo Tips - SAMPLE 2023-11-30
NUSMILE, LTD.
Avalon Biomed NeoPUTTY 0.65 g Kit - SAMPLE 2023-11-30
NUSMILE, LTD.
Zarc by AB NeoSEALER Flo Bioceramic Root Canal Sealer 0.5 g Kit - SAMPLE 2023-11-08
NUSMILE, LTD.
Avalon Biomed NeoSEALER Flo/NeoPUTTY Combo Kit 2.85 g - SAMPLE 2023-11-08
NUSMILE, LTD.
Zarc by AB NeoPUTTY Bioceramic Reparative Cement 1.2 g Kit - SAMPLE 2023-11-08
NUSMILE, LTD.
Zarc by AB NeoPUTTY Bioceramic Reparative Cement Intro Kit 0.5 g - SAMPLE 2023-11-07
NUSMILE, LTD.
Avalon Biomed NeoPUTTY Professional Kit 1.2 g - SAMPLE 2023-11-07
NUSMILE, LTD.
Avalon Biomed NeoPUTTY Introductory Kit 0.5 g - SAMPLE 2023-11-07
NUSMILE, LTD.
NuSmile NeoPUTTY Professional Kit 2.4 g - SAMPLE 2023-11-07
NUSMILE, LTD.
NuSmile NeoPUTTY 1.2 g Kit - SAMPLE 2023-11-07
NUSMILE, LTD.
NuSmile NeoPUTTY Introductory Kit 0.5 g - SAMPLE 2023-11-07
NUSMILE, LTD.
NeoSEALER EZ-Flo (2 x 1.5 g syringes + 30 Tips) Professional Kit - SAMPLE 2023-11-07
NUSMILE, LTD.
NeoSEALER EZ-Flo (2 x 1.5 g syringes + 30 Tips) Professional Kit 2023-11-07
NUSMILE, LTD.
NeoSEALER EZ-Flo (1.5 syringe) Refill Syringe - SAMPLE 2023-11-07
NUSMILE, LTD.
NeoSEALER EZ-Flo (1.5 g syringe & 15 Tips) Starter Kit - SAMPLE 2023-11-07
NUSMILE, LTD.
NeoSEALER EZ-Flo (1.5 g syringe & 15 Tips) Starter Kit 2023-11-07
NUSMILE, LTD.
NeoSEALER EZ-Flo (0.5 g Syringe + 4 Tips) Mini Kit - SAMPLE 2023-11-07
NUSMILE, LTD.
NeoLINER LC 1 g Kit (Canada) 2023-04-20
NUSMILE, LTD.
ApicalShaper sterile 21mm Z30/03 2023-04-20
NUSMILE, LTD.
Excalibur sterile 31mm E20-E45 2023-04-20
NUSMILE, LTD.
Excalibur sterile 25mm E20-E45 2023-04-20
NUSMILE, LTD.
Excalibur sterile 21mm E45 2023-04-20
NUSMILE, LTD.
NuSmile ZR Narrow Posterior Replacement Crown - First Primary Molar Mandibular L 2023-04-11
NUSMILE, LTD.
Flex Flo Tips 2 units 2023-03-29
NUSMILE, LTD.
Flex Flo Tips 40 units 2023-03-29
NUSMILE, LTD.
Flex Flo Tips 20 units 2023-03-29
NUSMILE, LTD.
NeoMTA2 Bioceramic Reparative Cement 2.5 g Kit 2023-03-29
NUSMILE, LTD.
NeoMTA2 Bioceramic Reparative Cement 0.5 g 2023-03-29
NUSMILE, LTD.
NeoMTA2 Bioceramic Reparative Cement 0.5 g 2023-03-29
NUSMILE, LTD.
NeoPUTTY Bioceramic Reparative Cement Refill Kit 1.2 g 2023-03-29
NUSMILE, LTD.
NeoPUTTY Bioceramic Reparative Cement Intro Kit 0.5 g 2023-03-29
NUSMILE, LTD.
NeoSEALER Flo Bioceramic Root Canal Sealer 2.2 g Kit + 20 Flex F 2023-03-29
NUSMILE, LTD.
NeoSEALER Flo Bioceramic Root Canal Sealer 2.2 g Refill Syringe 2023-03-29
NUSMILE, LTD.
NeoSEALER Flo Bioceramic Root Canal Sealer 0.5 g Kit 2023-03-29
NUSMILE, LTD.
NuSmile UCSM Replacement Band 2023-03-01
NUSMILE, LTD.
NuSmile UCSM Replacement Band 2023-03-01
NUSMILE, LTD.
NuSmile UCSM Replacement Band 2023-03-01
NUSMILE, LTD.
NuSmile UCSM Replacement Band 2023-03-01
NUSMILE, LTD.
NuSmile UCSM Replacement Band 2023-03-01
NUSMILE, LTD.
NuSmile UCSM Replacement Band 2023-03-01
NUSMILE, LTD.
NuSmile UCSM Replacement Band 2023-03-01
NUSMILE, LTD.
NuSmile UCSM Replacement Band 2023-03-01
NUSMILE, LTD
Avalon Biomed NeoSEALER Flo Tips2020-04-10
NUSMILE, LTD
NuSmile NeoPutty2019-12-09
NUSMILE, LTD
Avalon Biomed NeoSealer2019-12-09
NUSMILE, LTD
Avalon Biomed NeoPutty2019-12-09
NUSMILE, LTD
NuSmile NeoMTA 22019-09-09
NUSMILE, LTD
Avalon Biomed NeoMTA 22019-09-09
NuSmile, LTD.
MTA2.3 MATERIALS2019-01-11
NUSMILE, LTD
Avalon Biomed Grey MTA Plus2017-11-01
NUSMILE, LTD
NuSmile LED Curing Light2016-10-17
NUSMILE, LTD
NuSmile ZR Adjustment Bur2016-10-17
NUSMILE, LTD
NuSmile Signature Adjustment Bur2016-10-17
NUSMILE, LTD
NuSmile Preparation Bur2016-10-17
NUSMILE, LTD
NuSmile NeoMTA2015-09-14
NUSMILE, LTD
Avalon Biomed NeoMTA Plus2015-09-14
NUSMILE, LTD
NuSmile BioCem2014-04-02
NUSMILE, LTD
NuSmile BioCem2014-04-02
NUSMILE, LTD
NuSmile ZR2007-08-27
NUSMILE, LTD
NuSmile Signature2007-08-27
NUSMILE, LTD
NuSmile Pre-Contoured Stainless Steel Crowns2007-08-27
NUSMILE, LTD
NuSmile Pediatric Crowns2007-08-27

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020051615829Stadersand,Federal Republic of Germany -> Houston, TexasRIGID TUBES OUT OF 99.5 ALUMINIUM HS 761290 BANQBRE4249403 DEST HOU . .5 PKG
2020050923465Stadersand,Federal Republic of Germany -> Houston, TexasRIGID TUBES OUT OF 99.5 ALUMINIUM HS 761290 BANQBRE4249403 DEST HOU . .5 PKG

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