ORTHO DENTAL LAB, LLC

FDA Device Registration & Listing · Antioch, TN, US · Registration 3032193293

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
3032193293
FEI Number
3032193293
Entity Name
ORTHO DENTAL LAB, LLC
City/State/Country
Antioch, TN, US
Establishment Address
1530 Antioch Pike, Antioch, TN 37013, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
Ortho Dental Lab, LLC (Owner Number: 10091367)
Owner / Operator Contact Address
1530 Antioch Pike, Antioch, TN 37013, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SmileSet Nighttime Aligners SmileSet All-Day Aligners SmileSet Nighttime Clear Aligners Ortho Aligner System SmileSet Aligners SmileSet Premium Handheld Water Flosser SmileSet Water Flosser Replacement Tips SmileSet Premium Floss Picks SmileSet Aligner/Retainer Seater/Removal Tool SmileSet Wireless Whitening Light SmileSet Premium Whitening Kit SmileSet Retainers Impression Tray SmileSet Impression Tray SmileSet Night Guards SmileSet Premium Whitening SmileSet Premium Whitening Pen SmileSet Premium Whitening Kit SmileSet Premium Whitening Refill SmileSet Premium Sensitive Whitening Strips SmileSet Cheek Retractor SmileSet Aligners SmileSet Impression Kit IMPRESSION KIT SmileSet Premium Sonic Toothbrush SmileSet Premium Sonic Toothbrush Refill Heads

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NXC Aligner, Sequential Dental Class 2 872.5470 2024-09-07
EFS Unit, Oral Irrigation Dental Class 1 872.6510 2024-09-22
JES Floss, Dental Dental Class 1 872.6390 2025-09-24
ECR Setter, Band, Orthodontic Dental Class 1 872.4565 2025-09-24
EEG Heat Source For Bleaching Teeth Dental Class 1 872.6475 2024-09-26
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2024-09-07
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2025-09-04
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2025-08-20
MAU Eraser, Dental Stain Dental Class 1 872.6855 2024-12-28
EIG Retractor, All Types Dental Class 1 872.4565 2025-09-04
NXC Aligner, Sequential Dental Class 2 872.5470 2025-03-11
ELW Material, Impression Dental Class 2 872.3660 2024-09-22
JEQ Toothbrush, Powered Dental Class 1 872.6865 2024-09-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ortho Dental Lab, LLC
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
K844318 Pro Pulse, Inc. ORAL IRRIGATION TIP 1984-11-23
K882164 Arthur Blank & Co., Inc. FLOSS CARD 1988-06-10
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13

Similar Registrations

Registration Number Establishment Name Location
3027500898 EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada Escazu, San Rafael San Jose, CR
3035691085 CRISTALINE ALIGNERS GMBH Pforzheim Baden-Wurttemberg, DE
3031606517 Envista (Sichuan) Medical Device Co., Ltd. Ziyang Sichuan, CN
3009011037 MEM DENTAL TECHNOLOGY CO LTD Tainan, TW
3017155477 uLab Systems, Inc Memphis, TN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032193293. Last updated year: 2026. Please use registration number 3032193293 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.