NEW IMAGE DENTAL LABORATORY, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004860162	3004860162	NEW IMAGE DENTAL LABORATORY, INC.	1	N	2026-01-01	1395 Southlake Parkway Morrow GA US 30260

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
217385	1936524998	K173785	Custom Clear Aligner System	NXC	2018-03-13
217385	1046770928
217385	1106756395
217385	1123300386
217385	1424246479
217385	1621947297
217385	1626855025
217385	1650145265
217385	1668179565
217385	1786607741
217385	2059759207

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NXC	1	2018-03-13

GUDID#

EMA - A customized, removable,, and patient-adjustable intraoral device, often fabricated using 3D printing or milling technology, that utilizes interchangeable elastic straps of varying lengths and strengths to advance the mandible forward and open the bite.
New Image Dental Laboratory, Inc.
2026-02-11