Hismile Pty L T D

FDA Filings

This page includes the latest FDA filings for Hismile Pty 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 Number: 3014610038
• FEI Number: 3014610038
• Name: Fiona Chan
• Owner & Operator: HiSmile Pty Ltd
• Contact Address: Shop 1-7, 2563 Gold Coast Highway, ; Mermaid Beach AU-QLD Queensland 4218 AU
• US Agent:
  • Fiona Chan
  • SUNGO Technical Service Inc.
  • 855 9577779
  • sungo.group@yahoo.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6050 W EASTWOOD AVE APT 201, CHICAGO, ILLINOIS ; Chicago, IL 60630 US
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast HISMILE PTY LTD, ACCUPAC LLC	Otc Medication	2025-09-06
Hismile Hismile Pty Ltd, Accupac LLC	Otc Medication	2025-06-01
hismile COCONUT WHIP FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2025-05-29
hismile SMOOTH MINT FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2025-05-29
hismile RED VELVET FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2025-05-29
hismile WATERMELON FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2025-05-29
hismile MANGO SORBET FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2025-05-29
Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity Toothpast Hismile Pty Ltd, Accupac LLC	Otc Medication	2025-03-15
Hismile Pink Lemonade Sodium Fluoride Anticavity Toothpast Hismile Pty Ltd, Accupac LLC	Otc Medication	2025-03-15
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast Hismile Pty Ltd, Accupac LLC	Otc Medication	2025-03-15
Pink Lemonade Flavor Sodium Fluoride Anticavity Toothpast HISMILE PTY LTD, ACCUPAC LLC	Otc Medication	2024-09-21
Ice Pop Flavor Sodium Fluoride Anticavity Toothpast HISMILE PTY LTD, ACCUPAC LLC	Otc Medication	2024-09-21
HISMILE HISMILE PTY LTD	Otc Medication	2024-09-11
HISMILE HISMILE PTY LTD	Otc Medication	2024-08-16
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-08-01
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-08-01
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-31
Hismile HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-31
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-31
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-31
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-31
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-24
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-24
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-24
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-24
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-24
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-24
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-16
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-16
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-16
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-16
HISMILE HISMILE PTY LTD, Accupac LLC	Otc Medication	2024-07-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-07-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-07-13
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-07-13
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-07-13
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-07-13
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-07-13
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-07-13
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-07-13
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-07-13
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-16
Hismile Hismile Pty Ltd, Accupac, LLC	Otc Medication	2024-01-13
hismile SMOOTH MINT FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2023-08-11
hismile STRAWBERRY FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2023-07-28
hismile BANANA FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2023-07-28
hismile VANILLA FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2023-07-28
hismile GRAPE BUBBLEGUM FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2023-07-28
hismile RED VELVET FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2023-02-02
NDC 83013-305 HISMILE PTY LTD	Hismile WATERMELON FLAVOR Anticavity	2022-12-09
NDC 83013-304 HISMILE PTY LTD	Hismile SMOOTH MINT FLAVOR Anticavity	2022-12-09
NDC 83013-303 HISMILE PTY LTD	Hismile MANGO SORBET FLAVOR Anticavity	2022-12-09
NDC 83013-302 HISMILE PTY LTD	Hismile COCONUT WHIP FLAVOR Anticavity	2022-12-09
NDC 83013-301 HISMILE PTY LTD	Hismile PEACH ICED TEA FLAVOR Anticavity	2022-12-09
hismile COCONUT WHIP FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2022-12-09
hismile SMOOTH MINT FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2022-12-09
hismile PEACH ICED TEA FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2022-12-09
hismile WATERMELON FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2022-12-09
hismile MANGO SORBET FLAVOR anticavity HISMILE PTY LTD	Otc Medication	2022-12-09
MAU Fiona Chan [HiSmile Pty Ltd]	Teeth whitening kit, Teeth whitening gel, Teeth whitening pen	2018-05-31
EHY Fiona Chan [HiSmile Pty Ltd]	Mouth tray	2018-05-31
EEG Fiona Chan [HiSmile Pty Ltd]	Teeth whitening device	2018-05-31

Similar & Related FDA Registered Companies

• ACCUPAC LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092825772	Shanghai ,China (Mainland) -> Oakland, California	CARDBOARD CARTO	92 PKG
2020092616831	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	TEETH WHITENING KIT TEETH WHITENING REFILL PACK	166 CTN
2020091039365	Yantian,China (Mainland) -> Oakland, California	TEETH WHITENING KIT TEETH WHITENING REFILL PACK	125 CTN
2020082914058	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	TEETH WHITENING KIT	120 CTN
2020081723771	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	TEETH WHITENING KIT US VAT NUMBER 184701 66698	100 CTN
2020080634329	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	CARDBOARD CARTON	3 PKG
2020073019220	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	TEETH WHITENING KIT TOOTHPASTE	114 CTN
2020061315363	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	BUBBLE MAILER	44 PKG