Manufacturer registered with FDA

Neodontics, Inc.

Glendale, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10027368Manufacturer

Device types listed: 1
Brands and models: 16
510(k) clearances: 21982–1995
Markets registered in: 24 registrations outside the US
Establishments: 1United States

510(k) clearances per year, 1980–2026

Registered in 2 markets

Where regulators' registries name Neodontics, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Neodontics, Inc.	2 clearances	1982–1995	Below
South Korea	MFDS	Manufacturer	Neodontics Inc.Neodontics, Inc. · Neodontics. Inc	4	2003–2010	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Neodontics, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Base Metal AlloyEJH · Class 2	Dental alloys	Maker	CERAMIC ALLOYS w/Be.CERAMIC ALLOYS w/o Be.COBAFLEX-1COBAFLEX-3FORMULA 45+TiNEOALLOYNEOCAST CNEOCAST SNEOCAST VNEODONTICS, INC. -PRODUCT NAMES 6 more NEOTITANNEOTITAN-PDNICROLITENICROMEDP.D. ALLOYS (PARTIAL DENTURE ALLOYS)ZAIRE	2009

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Neodontics, Inc. as the applicant.

Decided	510(k)	Device	Device type
23 Mar 1995	K950951	NEOCAST C, V, S	EJH Base Metal Alloy
30 Aug 1982	K821025	NEODONTICS DENTAL IMPLANT	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
NEODONTICS INCFDA reg. 2027244	Glendale, CA, United States	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10027368). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.