Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011191212

FEI Number

3011191212

Entity Name

ESTHETIC ORTHODONTIC COMPANY OF AMERICA LLC

City/State/Country

St Petersburg, FL, US

Establishment Address

2860 Scherer Drive North, Suite 650, St Petersburg, FL 33716, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Esthetic Orthodontic Company of America LLC (Owner Number: 10047486)

Owner / Operator Contact Address

2860 Scherer Drive, Suite 650, Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IPR Handsaws IPR Thickness Gauge Aseptalign IPR Diamond strips fine IPR Diamond strips medium IPR Diamond strips superfine Diamond Bur Munchies Maxx Refill Pack Munchies Firm Refill Pack Munchies Starter Pack Munchies Gentle Refill Pack Munchies® VIBE SpaceCHQR Aligner Removal Tool Divulge d.Mistify Buccal cheek retractor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2014-09-17
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2015-04-23
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	Dental	Class 1	872.6855	2022-03-30
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2014-12-09
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2015-08-14
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2020-01-06
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2022-03-30
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2015-09-25
QJC	Plaque Disclosing Agent	Dental	Class 1	872.6855	2022-02-01
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2022-06-07
EIG	Retractor, All Types	Dental	Class 1	872.4565	2014-09-26

Official Correspondent

Belinda Askew

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Esthetic Orthodontic Company of America LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011191212. Last updated year: 2026. Please use registration number 3011191212 when referencing this establishment in official correspondence.