Manufacturer registered with FDA
Bicon, LLC
Boston, MA, United States. Lists 18 dental device types with FDA across 1 registered establishment, and holds 18 510(k) clearances as applicant.
- Device types listed
- 18
- Brands and models
- 44
- 510(k) clearances
- 181997–2015
- Markets registered in
- 14663 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 14 markets
Where regulators' registries name Bicon, LLC 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 | Bicon, LLC | 18 clearances | 1997–2015 | Below |
| European Union | EUDAMED | Manufacturer | Bicon, LLC | 525 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | BICON, LLC | 28 | 1999–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BICON, LLC | 25 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Bicon Inc.Bicon, LLC · Bicon, Inc · +2 | 25 | 2001–2013 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Bicon, LLC. | 12 | 2022–2023 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Bicon, LLC | 10 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Bicon LLC | 9 | 2008–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BICON, LLCBicon, LLC | 9 | 2004–2023 | Pure Global AI |
| China | NMPA | Registration holder | 百康有限公司BICON, LLC百康有限公司BICON, LLC. · 百康有限公司BICON,LLC · +2 | 5 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Bicon, LLC.Bicon, LLC | 5 | 2025–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BICON LLC | 5 | 2012–2022 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｂｉｃｏｎ， ＬＬＣ． | 3 | 2014–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Bicon LLC | 2 | — | 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 Bicon, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Bicon ImplantIntegra-CPIntegra-TiMAX 2.5 Implant SystemOriginal Bicon Dental Implant Syste3mm Narrow Bicon Implant System4.5 x 6mm and 6 x 6mm Implant4.5mm Implants - 8,11,14mm Lengths5 x 6mm Implant System5mm SHORT Implants 2 more6 x 5.7mm Implant System6 x 8mm Implant | 2007 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | TRINIA | 2014 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | ImpulsionWI-75 E/KM | 2016 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Pilot Drill | 2026 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Bone ExpanderChiselHand ReamerOsteotomeSeating TipSulcus ReamerTissue Punches | 2013 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | TRINIA | 2014 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | Hydroplastic Resin | 2014 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | TRINIA | 2014 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Gauges | 2013 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Latch ReamerPilot Drill | 2013 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Lister | Polishing Kit IAC | 2014 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | AEU-26BIC | 2016 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | Chisel | 2014 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Lister | Osteotome | 2014 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | SynthoGraft | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | AnalogsBrevis ComponentsFixed-Detachable ComponentsImpression CopingsLocator Components | 2013 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | MAX 2.5 Implant System | 2011 |
| Non-Irrigation Endosseous Dental Implant Drill BitsQRQ · Class 1 | Implant instruments & surgical kits | Maker | ReamersSpade DrillsSurgical KitsTissue Punches | 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 Bicon, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Jun 2015 | K143524 | Fiber Disks and Blocks (TRINIA) | EBF Resin Tooth Shade Material |
| 14 Mar 2014 | K133608 | TRINIA | EBF Resin Tooth Shade Material |
| 1 Oct 2010 | K101849 | BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 15 Oct 2009 | K092035 | BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION | DZE Root-Form Endosseous Implant |
| 10 Oct 2008 | K073368 | 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 21 Nov 2006 | K062044 | THE 5.0 X 6.0MM DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 1 Sep 2005 | K051091 | SYNTHOGRAFT | LYC Synthetic Bone Grafting Material |
| 22 Apr 2005 | K050712 | 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 7 Apr 2005 | K050408 | BICON ORTHODONTIC IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 23 Nov 2004 | K031568 | BICONITE SURFACE TREATMENT | DZE Root-Form Endosseous Implant |
| 15 Nov 2004 | K042637 | THE 5.0 X 6.0MM DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 29 Jan 2003 | K023705 | BICON TRANSITIONAL IMPLANT (BTI) SYSTEM | DZE Root-Form Endosseous Implant |
| 30 Dec 2002 | K010185 | 6.0 X 5.7MM DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 11 Jan 2000 | K994037 | THE 4.5MM DIAMETER BICON DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 26 Jan 1999 | K982488 | BICON BONE SCREW SYSTEM | DZE Root-Form Endosseous Implant |
| 12 Nov 1997 | K973056 | BONE GRAFT SCREW SYSTEM | DZL Intraosseous Fixation Screw |
| 17 Sep 1997 | K972417 | THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 18 Aug 1997 | K972029 | BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Shofu Inc (1).
Also lists devices cleared under other names
Bicon, LLC 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: Aseptico, Inc. (2), W&H Dentalwerk Buermoos GmbH (1), Stryker (1), Driskell Bioengineering (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Jun 2011 | K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | Aseptico, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 4 Mar 2002 | K020137 | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON | Aseptico, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 28 Jun 2001 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | W&H Dentalwerk Buermoos GmbH | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 10 Mar 1994 | K921805 | STRYKER PRECISION DENTAL IMPLANT SYSTEM | Stryker | DZE Root-Form Endosseous Implant |
| 31 Oct 1985 | K853788 | DB PRECISION IMPLANT SYSTEM | Driskell Bioengineering | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BICON, LLCFDA reg. 1223843 | Boston, MA, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9010847). 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.