Manufacturer registered with FDA

Medical Products Laboratories, Inc.

Philadelphia, PA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator2513595Contract manufacturer

Device types listed: 3
Brands and models: 1
510(k) clearances: 21985–2004
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 1980–2026

Devices listed with FDA

What Medical Products Laboratories, 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
Oral Cavity Abrasive Polishing AgentEJR · Class 1	Polishing & prophylaxis	Maker	Enamel Pro	1992
Cavity VarnishLBH · Class 2	Sealants & varnishes	Maker	—	2006
Root Canal Endodontic PreparerEKQ · Class 1	Endodontic files	Maker	—	1992

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 Medical Products Laboratories, Inc. as the applicant.

Decided	510(k)	Device	Device type
4 Feb 2004	K040098	VARNISHAMERICA	LBH Cavity Varnish
18 Jan 1985	K844572	PRE-KLENE ENAMEL CLEANER	EFT Over the Counter Denture Cleanser

Some of these clearances are listed with FDA today by another company: 3D Dental Designs and Development LLC (1), SPS/Crosstex International (1), DMG America, L.L.C. (1), Premier Dental Products Company (1), Young Innovations Inc (1), AMD Medicom Inc (1).

Registered establishments

Establishment	Location	What it does
MEDICAL PRODUCTS LABORATORIES, INC.FDA reg. 2513595	Philadelphia, PA, United States	Contract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 2513595). 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.