DIGISMILES LAB

FDA Device Registration & Listing · Philipsburg, PA, US · Registration 3035335007

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035335007
FEI Number
3035335007
Entity Name
DIGISMILES LAB
City/State/Country
Philipsburg, PA, US
Establishment Address
219 N Second st, Suite #200, Philipsburg, PA 16866, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
DigiSmiles Lab (Owner Number: 10092397)
Owner / Operator Contact Address
220 Oakwood Dr, Philipsburg, PA 16866, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Alloy, Other Noble Metal temporary crown Teeth, Artificial, POSTERIOR with Metal Insert Alloy, Metal, Base Clasp Wire Crown Preformed

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJS Alloy, Other Noble Metal Dental Class 2 872.3060 2025-01-02
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2025-01-02
ELJ Teeth, Artificial, Posterior With Metal Insert Dental Class 1 872.3900 2025-01-02
EJH Alloy, Metal, Base Dental Class 2 872.3710 2025-01-02
EJW Clasp, Wire Dental Class 1 872.3285 2025-01-02
ELZ Crown, Preformed Dental Class 1 872.3330 2025-01-02

Official Correspondent

Alexander Boumerhi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DigiSmiles Lab
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K810521 C.Vaupel Dental, Inc. CO-SPAN 13.5 CASTING ALLOY 1981-03-17

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2921595 Sterngold Dental LLC Attleboro, MA, US
9611458 Dentaurum GmbH & Co. KG ISPRINGEN Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035335007. Last updated year: 2026. Please use registration number 3035335007 when referencing this establishment in official correspondence.
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