Registered with FDA
Tpc Advanced Technology, Inc.
City of Industry, CA, United States. Lists 25 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 25
- Brands and models
- 53
- 510(k) clearances
- 31999–2007
- Markets registered in
- 640 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 6 markets
Where regulators' registries name Tpc Advanced Technology, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Tpc Advanced Technology, Inc. | 3 clearances | 1999–2007 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | TPC ADVANCED TECHNOLOGY, INC | 20 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TPC ADVANCED TECHNOLOGY, INC.TPC ADVANCED TECHNOLOGY | 15 | 2006–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | TPC Advanced Technology | 3 | 2012–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TPC ADVANCED TECHNOLOGY INC. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TPC ADVANCED TECHNOLOGY, INC. | 1 | 2013–2013 | 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 Tpc Advanced Technology, 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 |
|---|---|---|---|---|
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | TPC Halogen Curing LightTPC LED Curing Light | 2008 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Lister | Bellagio Operatory PackageLaguna Hygiene Operatory PackageLaguna Operatory PackageLaguna Orthodontic Operatory PackageLaguna Swing Mount Operatory PackageMirage Hygiene Operatory PackageMirage Operatory PackageMirage Orthodontic Operatory PackageMirage Swing Mount Operatory PackageTPC USB Camera | 2008 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Dental handpiece | 2008 |
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Lister | TPC Fiber Optic System | 2005 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Lister | TPC LED Dental Light | 2005 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Lister | SuperbAir Air Compressor | 2021 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | TPC Air Driven Dental Drill | 2009 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Lister | TPC D650N Digital Amalgamator | 2002 |
| Roll CottonEFN · Class 1 | — | Lister | TPC Cotton Roll | 2024 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | TPC Disposable Plastic Xray Film Holder | 2005 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | TPC Disposable Prophy Cup | 2005 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | TPC Disposable High Volume Evacuator Tips | 2018 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Syringe | 2007 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Lister | TPC Dental file | 2012 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | TPC PM25 Scaler | 2008 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | TPC Advance 750 Piezo Perio Scaler | 2002 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Lister | Bellagio Operatory PackageLaguna Hygiene Operatory PackageLaguna Operatory PackageLaguna Orthodontic Operatory PackageLaguna Swing Mount Operatory PackageMirage Hygiene Operatory PackageMirage Operatory PackageMirage Orthodontic Operatory PackageMirage Swing Mount Operatory Package | 2026 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | TPC Disposable Fluoride Tray | 2024 |
| Carboxymethylcellulose Sodium (40-100&) Denture AdhesiveKOQ · Class 1 | — | Lister | TPC Denture Poly Grip Adhesive | 2008 |
| Color ScannerKZN · Class 2 | — | Lister | Infinity 5 ScannerRapid 5 Scanner | 2026 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | Mirage 2 Delivery System with Swivel Holder Bar- Export ONLYMirage Delivery System | 2007 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | TPC Barrier Films, Barrier Envelopes, Chair SleevesTPC Laguna Patient Chair | 2007 |
| Dental Hygiene KitNXZ · Class 1 | — | Lister | dental hygiene kit | 2007 |
| General Purpose Dental TrayOFX · Class 1 | — | Lister | TPC Stainless Steel Dental Tray | 2010 |
| Portable Dental Operative UnitSJH · Class 1 | — | Lister | MC3600CV Mirage Mobile CartMC3600CVSL Mirage Mobile CartOMC2375CV Mobile Orthodontic Cabinet w UnitOMC2375CVSL Orthodontic Mobile Cabinet w UnitPC2530 Mobile VacuumPC2630 Portable UnitPC2635 Mobile Dental UnitPC2930 Portable Unit | 2026 |
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 Tpc Advanced Technology, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Aug 2007 | K071485 | TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 | EIA Operative Dental Unit |
| 14 Jul 2005 | K051547 | POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 | ELC Ultrasonic Scaler |
| 29 Jan 1999 | K983029 | POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001 | ELC Ultrasonic Scaler |
Some of these clearances are listed with FDA today by another company: Kuang Yeu Co. Ltd (1), Lakong Medical Devices Co., Ltd. (1).
Also lists devices cleared under other names
Tpc Advanced Technology, 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: Lakong Medical Devices Co., Ltd. (2), Codent Technical Industry Co., Ltd. (1), Rolence Ent., Inc. (1), Rolence Enterprise, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 Sep 2026 | K254009 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Lakong Medical Devices Co., Ltd. | SJH Portable Dental Operative Unit |
| 7 Aug 2026 | K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | EIA Operative Dental Unit |
| 6 Feb 2004 | K033213 | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS | Codent Technical Industry Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 12 Jun 2002 | K020874 | ULTRA-LITE 5 TURBO LIGHT CURE UNIT | Rolence Ent., Inc. | EBZ Ultraviolet Activator for Polymerization |
| 10 Oct 2000 | K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT | Rolence Enterprise, Inc. | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TPC ADVANCED TECHNOLOGY, INC.FDA reg. 2031508 | City Industry, CA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9034634). 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.