Data / Medical devices / United States / Bicon, LLC
Bicon, LLC: FDA-registered device maker in Boston, MA, United States, 18 510(k) clearances
Bicon, LLC is registered with the FDA (registration 1223843) in Boston, MA, United States. It lists 20 device types. The FDA files 18 510(k) clearances under its listings, the newest dated June 2, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1223843
- FEI number
- 1000305589
- Address
- 501 Arborway, Boston, MA, United States, 02130
- Owner or operator
- Bicon, LLC (9010847)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 27, 2007
- Registered through
- 2027
- Brand names listed
- 3mm Guided Surgical Tray, 3mm Narrow Bicon Implant System, 4.5 x 6mm and 6 x 6mm Implant, 4.5mm Guided Surgical Tray, 4.5mm Implants - 8,11,14mm Lengths, 4mm Guided Surgical Tray, 5 x 6mm Implant System, 5mm Guided Surgical Tray and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2015 | K143524 | Fiber Disks and Blocks (TRINIA) | EBF | Substantially Equivalent | Bicon, LLC | accessdata.fda.gov |
| March 14, 2014 | K133608 | TRINIA | EBF | Substantially Equivalent | Bicon, LLC | accessdata.fda.gov |
| February 1, 2013 | K123538 | EPIEN ROOT CANAL CLEANSER | KJJ | Substantially Equivalent | Epien Medical, Inc. | accessdata.fda.gov |
| June 14, 2011 | K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | EKX | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101849 | BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT | DZE | Substantially Equivalent | Bicon, LLC | accessdata.fda.gov |
| October 15, 2009 | K092035 | BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION | DZE | Substantially Equivalent | Bicon, LLC | accessdata.fda.gov |
| October 10, 2008 | K073368 | 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT | DZE | Substantially Equivalent | Bicon, LLC | accessdata.fda.gov |
| September 1, 2005 | K051091 | SYNTHOGRAFT | LYC | Substantially Equivalent | Bicon, Inc. | accessdata.fda.gov |
| April 22, 2005 | K050712 | 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT | DZE | Substantially Equivalent | Bicon, Inc. | accessdata.fda.gov |
| November 15, 2004 | K042637 | THE 5.0 X 6.0MM DENTAL IMPLANT | DZE | Substantially Equivalent | Bicon, Inc. | accessdata.fda.gov |
| January 29, 2003 | K023705 | BICON TRANSITIONAL IMPLANT (BTI) SYSTEM | DZE | Substantially Equivalent | Bicon, Inc. | accessdata.fda.gov |
| December 30, 2002 | K010185 | 6.0 X 5.7MM DENTAL IMPLANT | DZE | Substantially Equivalent | Bicon, Inc. | accessdata.fda.gov |
| March 4, 2002 | K020137 | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON | EGS | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| June 28, 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 | EGS | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| January 11, 2000 | K994037 | THE 4.5MM DIAMETER BICON DENTAL IMPLANT | DZE | Substantially Equivalent | Bicon, Inc. | accessdata.fda.gov |
| September 17, 1997 | K972417 | THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Bicon, Inc. | accessdata.fda.gov |
| March 10, 1994 | K921805 | STRYKER PRECISION DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| October 31, 1985 | K853788 | DB PRECISION IMPLANT SYSTEM | DZE | Substantially Equivalent | Driskell Bioengineering | accessdata.fda.gov |
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Updated June 2, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.