Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042750929

FEI Number

3042750929

Entity Name

UNIVERSAL SHAPERS

City/State/Country

Woodbury, NY, US

Establishment Address

94 Cypress Dr, Woodbury, NY 11797, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Universal Sapers (Owner Number: 10094611)

Owner / Operator Contact Address

94 Cypress Drive, Woodbury, NY 11797, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Universal Shaper Dental Drills

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2025-12-10

Official Correspondent

Gary Bram

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Universal Sapers

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042750929. Last updated year: 2026. Please use registration number 3042750929 when referencing this establishment in official correspondence.