DENTSPLY NORTH AMERICA LLC

FDA Device Registration & Listing · Lancaster, PA, US · Registration 3006186796

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
3006186796
FEI Number
3006186796
Entity Name
DENTSPLY NORTH AMERICA LLC
City/State/Country
Lancaster, PA, US
Establishment Address
1800 Cloister Drive, Lancaster, PA 17601, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
DENTSPLY SIRONA INC (Owner Number: 2511302)
Owner / Operator Contact Address
221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Drills GATES LARGO Flex-View Interproximal Strips Interproximal Serrated Strips Caulk Post & Core Kit Paper Points

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFT Cleanser, Denture, Over The Counter Dental Class 1 872.3520 2005-12-28
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 1996-08-21
EHM Strip, Polishing Agent Dental Class 1 872.6010 2006-06-12
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2019-11-20
NTK Caries Detector, Laser Light, Transmission Dental Class 2 872.1745 2019-11-20
EKN Point, Paper, Endodontic Dental Class 1 872.3830 1996-08-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DENTSPLY SIRONA INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9612618 DEGUDENT GMBH Rosbach V.D.H. Hesse, DE
3003756493 DENTSPLY INDUSTRIA E COMERCIO LTDA PIRASSUNUNGA Sao Paulo, BR
3001226627 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) ST. EGREVE Isere, FR
3003136642 OraMetrix GmbH Berlin Brandenburg, DE
3000303964 DENTSPLY DENTAL (TIANJIN) CO., LTD. TEDA Tianjin, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K902838 Denture Dynamic'S, Inc. DENTURE DYNAMIC'S DENTURE MAGIC 1990-09-06
K243921 Foshan Coxo Medical Instrument Co., Ltd. LED Curing Lights (DB686 HALO) 2025-04-11
K033201 Apoza Enterprise Co., Ltd. LA500 BLUE LIGHT 2003-12-02

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1821514 KULZER, LLC SOUTH BEND, IN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006186796. Last updated year: 2026. Please use registration number 3006186796 when referencing this establishment in official correspondence.
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