The American Angle, LLC

FDA Device Registration & Listing · Brooklyn, NY, US · Registration 3034725654

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
3034725654
FEI Number
3034725654
Entity Name
The American Angle, LLC
City/State/Country
Brooklyn, NY, US
Establishment Address
8300 4th ave, No. 405, Brooklyn, NY 11209, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
American Angle Ortho, LLC (Owner Number: 10092173)
Owner / Operator Contact Address
8300 4th ave, No. 405, Brooklyn, NY 11209, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AUX Buttons, AUX Hooks, AUX Stops, AUX Golden Chain, AUX Sheath & Cleat, Buccal Tubes orthodontics Beta Titanium Archwires, Cord Archwire Springs Cord Nickel Titanium Archwires, Cord Stainless Steel Archwires, Cord Brilliance Ceramic Bracket, Pearl Ceramic Bracket, Pearl-Compact Ceramic Brackets, Pliers orthodontics Aurora Stainless Steel Mirrors, Aurora Glass Mirrors Donuts Elastic, Donuts Elastomeric Ligature Ties, Donuts Power Chains, Donuts Rotaition Wedges, Donuts Bumper Tubing, Donuts Separators

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2024-12-11
DZD Tube, Orthodontic Dental Class 1 872.5410 2024-12-20
ECN Clamp, Wire, Orthodontic Dental Class 1 872.5410 2024-12-11
JEX Plier, Orthodontic Dental Class 1 872.4565 2024-12-20
EAX Mirror, Mouth Dental Class 1 872.4565 2024-12-11
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2024-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

American Angle Ortho, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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 3034725654. Last updated year: 2026. Please use registration number 3034725654 when referencing this establishment in official correspondence.
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