GERGENS ORTHODONTIC LAB

FDA Device Registration & Listing · Phoenix, AZ, US · Registration 3008274496

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
3008274496
FEI Number
3008274496
Entity Name
GERGENS ORTHODONTIC LAB
City/State/Country
Phoenix, AZ, US
Establishment Address
1745 West Deer Valley Rd, Suite 112, Phoenix, AZ 85027, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Gergens Orthodontic Lab (Owner Number: 10031363)
Owner / Operator Contact Address
1745 W Deer Valley Rd Suite 112, Phoenix, AZ 85027, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K113126
PMA Number
N/A

All Registered Proprietary Names

mRNA Appliance Vivos DNA Appliance Acylic Herbst

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRK Device, Anti-Snoring Dental Class 2 872.5570 2018-12-21
DZC Wire, Orthodontic Dental Class 1 872.5410 2019-07-10
LRK Device, Anti-Snoring Dental Class 2 872.5570 2013-08-15

Official Correspondent

David Gergen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gergens Orthodontic Lab
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
K122391 Medtronic Xomed, Inc. MEDTRONIC XOMED, INC. 2013-01-10
K112640 Ormco Corp. HYPERELASTIC WIRE 2011-11-16

Similar Registrations

Registration Number Establishment Name Location
3030914478 GELB PRACTICE Dix Hills, NY, US
3017092365 APNOMED, INC. Bellevue, WA, US
3039643908 EMA-SLEEP INC Bastrop, TX, US
3007108578 TRUE FUNCTION LABORATORY INC La Mesa, CA, US
3006786034 Innovative Health Technologies (NZ) Limited Dunedin Otago, NZ
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008274496. Last updated year: 2026. Please use registration number 3008274496 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.