510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bicon, LLC

Boston, MA, US

BICON, LLC appears in FDA device records in Boston, MA. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Bicon, LLC between 1997 and 2015. The busiest year on record is 1997, with 3. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bicon, LLC, by decision year
YearClearances
19973
19991
20001
20021
20031
20042
20053
20061
20081
20091
20101
20141
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K143524Fiber Disks and Blocks (TRINIA)EBFSubstantially Equivalent
K133608TRINIAEBFSubstantially Equivalent
K101849BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANTDZESubstantially Equivalent
K092035BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTIONDZESubstantially Equivalent
K0733685.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANTDZESubstantially Equivalent
K062044THE 5.0 X 6.0MM DENTAL IMPLANTDZESubstantially Equivalent
K051091SYNTHOGRAFTLYCSubstantially Equivalent
K0507124.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANTDZESubstantially Equivalent
K050408BICON ORTHODONTIC IMPLANT SYSTEMDZESubstantially Equivalent
K031568BICONITE SURFACE TREATMENTDZESubstantially Equivalent
K042637THE 5.0 X 6.0MM DENTAL IMPLANTDZESubstantially Equivalent
K023705BICON TRANSITIONAL IMPLANT (BTI) SYSTEMDZESubstantially Equivalent
K0101856.0 X 5.7MM DENTAL IMPLANTDZESubstantially Equivalent
K994037THE 4.5MM DIAMETER BICON DENTAL IMPLANTDZESubstantially Equivalent
K982488BICON BONE SCREW SYSTEMDZESubstantially Equivalent
K973056BONE GRAFT SCREW SYSTEMDZLSubstantially Equivalent
K972417THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K972029BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEMDZESubstantially Equivalent

Registered establishments

FDA registered establishments for Bicon, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12238431000305589BICON, LLC501 Arborway, Boston, MA 02130 US2026and 8 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain