Data / Medical devices / United States / Johns Dental Laboratory

Johns Dental Laboratory: FDA-registered device maker in Terre Haute, IN, United States, 1 510(k) clearance

Name: Johns Dental Laboratory FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Johns Dental Laboratory is registered with the FDA (registration 3014680794) in Terre Haute, IN, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 9, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014680794
Address: 423 S 13th Street, Terre Haute, IN, United States, 47807
Owner or operator: Johns Dental Lab (10058109)
Roles: Contract manufacturer, Manufacturer
First device listed: August 26, 2018
Registered through: 2026
Brand names listed: EMA 3D, Elastic Mandibular Advancement (EMA) appliance, Indirect Bonding Tray, Redline, Redline Clear Aligner System, Vivos DNA, Vivos mRNA, Vivos mmRNA

Devices it lists

Device	Product code	Class	Role	Source
Aligner, Sequential	NXC	2	Manufacturer	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Contract manufacturer	accessdata.fda.gov
Device, Jaw Repositioning	LQZ	2	Contract manufacturer	accessdata.fda.gov
Indirect Bonding Tray	QJJ	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 9, 2022	K213297	Redline	NXC	Substantially Equivalent	Johns Dental Laboratories	accessdata.fda.gov

Compare with other makers

Updated February 9, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.