Manufacturer registered with FDA
Dentalez, Inc.
Malvern, PA, United States. Lists 17 dental device types with FDA across 2 registered establishments, and holds 9 510(k) clearances as applicant.
- Device types listed
- 17
- Brands and models
- 95
- 510(k) clearances
- 92007–2026
- Markets registered in
- 5124 registrations outside the US
- Establishments
- 2United States
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Dentalez, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dentalez, Inc. | 9 clearances | 2007–2026 | Below |
| Canada | Health Canada | Registration holder | DENTALEZ, INC., STARDENTAL DIVISION | 118 | 2001–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DENTALEZ INC- STARDENTAL DIVISION | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTALEZ, INC. | 2 | 2010–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DentalEZ, Inc. StarDental Division | 1 | 2004–2004 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Dentalez, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Concentrix MX Handpiece - 265630DentaLube II - 262539HiFlo Fiber Optic SwivelLED Plug N Play Swivel AssemblyLED SwivelLubricant, Electric HPProphy Star 3 Handpiece - 264422Prophy Star 3 SW Handpiece - 266281Simplicity FX Handpiece - 265634Star 400 Flex Handpiece, LubeFree, Fiber Optic 19 moreStar 400 Flex Handpiece, LubeFree, non-Fiber OpticStar 400 Flex Handpiece, Lubricated, Fiber OpticStar 400 Flex Handpiece, Lubricated, non-Fiber OpticStar 440 Flex HandpiecesStar 440 HandpieceStar 500 Elite Handpiece, LubeFree, Fiber OpticStar 500 Elite Handpiece, LubeFree, non-Fiber OpticStar 500 Elite Handpiece, Lubricated non-Fiber OpticStar 500 Elite Handpiece, Lubricated, Fiber OpticStar 500 Swivel, non-Fiber OpticStar 500 Swlvel, Fiber Optic2-line Non-Fiber Optic Swivel4-line Non-Fiber Optic Swivel430 Series Lube Free High Speed Handpieces - 266153, 266182, 262057, 262052, 268840, 264450, 268841430 Series Lubricated High Speed Handpieces - 266154, 266183, 264451, 268861, 264951, 264952430 SW 45 Handpiece - 265822430 SWL 45 Handpiece - 265821430 Torque HP5-Hole Fiber Optic Swivel | 2016 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | ETorque Handpieces - 265471, 265472, 265473, 265474, 265475Star E900 1:1 Auto Latch, Fiber Optic Handpiece - 266343Star E900 1:1 Straight, Handpiece - 266345Star E900 1:5 Auto Chuck, Fiber Optic Handpiece - 266342Star E900 1:5 Auto Chuck, Non-Fiber Optic, Handpiece - 266490Star Titan 20K Motor FXStar Titan 20K Motor SWStar Titan 5K Motor FXStar Titan 5K Motor SWTitan 3 Attachments 11 moreTitan 3 Lubefree AnglesTitan 3 Lubricated AnglesTitan 3 MotorsTitan EX AnglesTitan EX AttachmentsTitan EX Motor 20KTitan-E 20K MotorTitan-T AttachmentsTitan-T Lubefree AnglesTitan-T Lubricated AnglesTitan-T Motors | 2007 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Star E900 Electric SystemStar ETorque Electric Motor System - 265461, 265464, 265463, 268880 | 2017 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | CORE Delivery UnitGalaxy Delivery UnitStarBright Dual Lamp Control SystemStarBright Single Lamp Control System | 2008 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Classique Diamond Burs | 1992 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | CORE LightSimplicity LED LightSimplicity Light | 1992 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | Visi-Frame | 1992 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | Hand Instruments Explorers - Endodontic | 1999 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | Hand Instruments - Excavators | 1992 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Hand Instrument - Spreaders | 1992 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | Hand Instruments - Pluggers | 1992 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | iStar Cordless Prophy Handpiece | 2015 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Titan Blis-sonic Scalers | 2007 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Hand Instruments - Scalers | 1992 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | Hand Instrument - Curettes | 1992 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Barracuda CV-101Barracuda CV-102Barracuda MC-201Barracuda MC-202NXT Hg5 Amalgam SeparatorNXT Hg5 High Volume Amalgam SeparatorNXT Hg5 MINI Amalagam SeparatorRamvac 10 Dry Vacuum System (Bison 7)Ramvac 12 CompressorRamvac 12 Dry Vacuum System (Bison 9) 14 moreRamvac 18 CompressorRamvac 3 CompressorRamvac 3 Compressor w/Sound ShieldRamvac 4 Dry Vacuum System (Bulldog QT 2)Ramvac 5 CompressorRamvac 5 Compressor w/Sound ShieldRamvac 5 Dry Vacuum System (Bison 3)Ramvac 7 Dry Vacuum System (Bison 5)Ramvac 8 CompressorRamvac Badger LF Dry VacuumRamvac Tanks 15 Gallon TankRamvac Tanks 30 Gallon TankRamvac Tanks 50 Gallon Cylindrical TankRamvac Tanks Infini Tank | 2019 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | CORE ChairNuSimplicity Chair | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Dentalez, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Jan 2026 | K251701 | Star E900 Electric System | EBW Handpiece and Cord Foot Controller |
| 19 Sep 2024 | K240183 | Star E900 Handpiece Series | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 6 Jan 2020 | K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece | EFB Dental Air-Powered Handpiece |
| 28 Mar 2018 | K173465 | Concentrix MX-AC High-Speed Handpiece | EFB Dental Air-Powered Handpiece |
| 19 Jan 2017 | K162397 | Titan 3 Low Speed Angle Attachments | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 8 Apr 2016 | K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece | EFB Dental Air-Powered Handpiece |
| 23 Jan 2012 | K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES | EFB Dental Air-Powered Handpiece |
| 28 Dec 2009 | K093072 | STARCARE HANDPIECE MAINTENANCE UNIT | EFB Dental Air-Powered Handpiece |
| 15 Jun 2007 | K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 | EFB Dental Air-Powered Handpiece |
Also lists devices cleared under other names
Dentalez, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentalez Group (3), Nakanishi, Inc. (2), Coltene/Whaledent AG (2), Dentalez Group, Stardental Division (1), Dci Intl. (1), Den-Tal-Ez Mfg Co., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Aug 2017 | K163483 | PANA SPRAY Plus | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 31 Jan 2014 | K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | Coltene/Whaledent AG | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 25 Sep 2013 | K130455 | 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES | Dentalez Group, Stardental Division | EFB Dental Air-Powered Handpiece |
| 12 Sep 2013 | K131578 | IPROPHY MOBILE | Nakanishi, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 24 Jul 2009 | K090937 | E-STATIS 40 SYSTEM | Coltene/Whaledent AG | EBW Handpiece and Cord Foot Controller |
| 8 Jan 1999 | K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | Dentalez Group | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 22 Oct 1998 | K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE | Dentalez Group | EFB Dental Air-Powered Handpiece |
| 29 Dec 1994 | K944271 | DENTAL OPERATIVE UNIT ACCESORIES | Dci Intl. | EIA Operative Dental Unit |
| 8 Jul 1993 | K931204 | AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) | Den-Tal-Ez Mfg Co., Inc. | EIA Operative Dental Unit |
| 21 Apr 1988 | K881253 | ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW | Dentalez Group | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTALEZ OF ALABAMAFDA reg. 1049061 | BAY MINETTE, AL, United States | Complaint file establishment, Manufacturer, Repacker / relabeler |
| DENTALEZ, INC., STARDENTAL DIVISIONFDA reg. 2520265 | Lancaster, PA, United States | Manufacturer, Repacker / relabeler, Specification developer |
Other names on FDA records
DentalEZ, Inc. StarDental Division · Dentalez of Alabama
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2513147). 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.