DENTALEZ, INC., STARDENTAL DIVISION

FDA Device Registration & Listing · Lancaster, PA, US · Registration 2520265

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
2520265
FEI Number
2520265
Entity Name
DENTALEZ, INC., STARDENTAL DIVISION
City/State/Country
Lancaster, PA, US
Establishment Address
1816 Colonial Village Ln, Lancaster, PA 17601, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DENTALEZ, INC. (Owner Number: 2513147)
Owner / Operator Contact Address
301 Lindenwood Drive, Suite 100, Malvern, PA 19355, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K130455
PMA Number
N/A

All Registered Proprietary Names

Star E900 Electric System StarBright Dual Lamp Control System StarBright Single Lamp Control System LED Plug N Play Swivel Assembly 430 Torque HP 5-Hole Fiber Optic Swivel HiFlo Fiber Optic Swivel LED Swivel 4-line Non-Fiber Optic Swivel 2-line Non-Fiber Optic Swivel Star 440 Handpiece Star ETorque Electric Motor System - 265461, 265464, 265463, 268880 Titan Blis-sonic Scalers Lubricant, Electric HP Prophy Star 3 Handpiece - 264422 Prophy Star 3 SW Handpiece - 266281 DentaLube II - 262539 Hand Instrument - Curettes Hand Instrument - Spreaders Hand Instruments - Pluggers Hand Instruments Explorers - Endodontic 430 Series Lubricated High Speed Handpieces - 266154, 266183, 264451, 268861, 264951, 264952 430 Series Lube Free High Speed Handpieces - 266153, 266182, 262057, 262052, 268840, 264450, 268841 iStar Cordless Prophy Handpiece Visi-Frame Star E900 1:1 Straight, Handpiece - 266345 Star E900 1:5 Auto Chuck, Fiber Optic Handpiece - 266342 Star E900 1:5 Auto Chuck, Non-Fiber Optic, Handpiece - 266490 Star E900 1:1 Auto Latch, Fiber Optic Handpiece - 266343 ETorque Handpieces - 265471, 265472, 265473, 265474, 265475 Star 500 Swivel, non-Fiber Optic Star 500 Elite Handpiece, Lubricated non-Fiber Optic Star 500 Swlvel, Fiber Optic Star 400 Flex Handpiece, Lubricated, Fiber Optic Star 500 Elite Handpiece, LubeFree, non-Fiber Optic Star 500 Elite Handpiece, LubeFree, Fiber Optic Star 500 Elite Handpiece, Lubricated, Fiber Optic Star 400 Flex Handpiece, Lubricated, non-Fiber Optic Star 400 Flex Handpiece, LubeFree, non-Fiber Optic Star 400 Flex Handpiece, LubeFree, Fiber Optic Hand Instruments - Scalers 430 SWL 45 Handpiece - 265821 430 SW 45 Handpiece - 265822

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2026-01-21
EIA Unit, Operative Dental Dental Class 1 872.6640 2015-10-27
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2016-04-21
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2017-11-07
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-10-10
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2019-08-08
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2024-10-22
EMS Curette, Periodontic Dental Class 1 872.4565 1992-09-30
EKK Spreader, Pulp Canal Filling Material, Endodontic Dental Class 1 872.4565 1992-09-30
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 1992-09-30
EKB Explorer, Operative Dental Class 1 872.4565 1999-11-15
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2026-04-21
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2015-02-02
EJE Frame, Rubber Dam Dental Class 1 872.6300 1992-09-30
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2025-05-06
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2017-11-07
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2020-01-08
EMN Scaler, Periodontic Dental Class 1 872.4565 1992-09-30
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2024-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DENTALEZ, 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
1049061 DENTALEZ OF ALABAMA BAY MINETTE, AL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K040153 Indigenous Peoples Technology and Education Center I-TEC PORTABLE DENTAL OPERATORY 2004-05-21
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06
K241065 Dentis Co., Ltd. ChecQ (AC100) 2025-03-21

Similar Registrations

Registration Number Establishment Name Location
3014683120 JMU DENTAL, INC Fullerton, CA, US
3009768364 Foshan CICADA Dental Instrument Co., Ltd. Foshan Guangdong, CN
9611253 NAKANISHI INC. Kanuma Tochigi, JP
1054713 TOYO MEDICAL CO. Doral, FL, US
3025599428 SANKO ELECTRONICS CORPORATION Midori Gunma, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2520265. Last updated year: 2026. Please use registration number 2520265 when referencing this establishment in official correspondence.
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