Smyles Above Innovations, Inc

FDA Device Registration & Listing · Barrington, IL, US · Registration 3030228577

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030228577
FEI Number
3030228577
Entity Name
Smyles Above Innovations, Inc
City/State/Country
Barrington, IL, US
Establishment Address
205 West Main Street, Barrington, IL 60010, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Smyles Above Innovations, Inc (Owner Number: 10089519)
Owner / Operator Contact Address
205 West Main Street, Barrington, IL 60010, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

The AutoFlosser The AutoFlosser FLOSS IrriGUIDE Adapter IrriGUIDE Surgical Guide IrriGUIDE Trimming Bur IrriGUIDE Seating Bur

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JES Floss, Dental Dental Class 1 872.6390 2024-10-11
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2023-12-13
EJL Bur, Dental Dental Class 1 872.3240 2024-02-01

Official Correspondent

Thomas Jackson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Smyles Above Innovations, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882164 Arthur Blank & Co., Inc. FLOSS CARD 1988-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030228577. Last updated year: 2026. Please use registration number 3030228577 when referencing this establishment in official correspondence.
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