Registered with FDA

Universal Sapers

Woodbury, NY, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10094611Repacker / relabeler
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1United States

Devices listed with FDA

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

Device typeCategoryRoleBrands and modelsListed since
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsLister
Universal Shaper Dental Drills
2025

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

Registered establishments

EstablishmentLocationWhat it does
UNIVERSAL SHAPERSFDA reg. 3042750929Woodbury, NY, United StatesRepacker / relabeler

Other names on FDA records

Universal Shapers

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10094611). 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.