Manufacturer registered with FDA

OnTel Products Corp

Fairfield, NJ, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10048404Specification developer

Device types listed: 1
Brands and models: 5
510(k) clearances: 11998–1998
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 1990–2026

Devices listed with FDA

What OnTel Products Corp currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Oral Irrigation UnitEFS · Class 1	Oral irrigators	Maker	Miracle SmileMiracle Smile Head Pack MOWater Flosser Head Pack MOWater Flosser Replacement HeadsWater Flosser Total Care Cleaning Heads	2023

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 OnTel Products Corp as the applicant.

Decided	510(k)	Device	Device type
20 May 1998	K980842	COPPER TONGUE SCRAPER	LCN Tongue Scraper

Registered establishments

Establishment	Location	What it does
ONTEL PRODUCTS CORPORATIONFDA reg. 3011457702	Fairfield, NJ, United States	Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10048404). 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.