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

Lexington, MA, US

Astra Tech, Inc. appears in FDA device records in Lexington, MA. FDA records list 38 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
38
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 38 510(k) clearances for Astra Tech, Inc. between 1994 and 2013. The busiest year on record is 2011, with 7. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for Astra Tech, Inc., by decision year
YearClearances
19941
19983
19992
20012
20021
20031
20042
20051
20061
20072
20083
20094
20102
20117
20125
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K121810OSSEOSPEED ANGLED ABUTMENT EVNHASubstantially Equivalent
K122078LOFRIC PRIMO, LOFRIC HYDRO-KITEZDSubstantially Equivalent
K120414OSSEOSPEED PLUSDZESubstantially Equivalent
K120338ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIANHASubstantially Equivalent
K113424LOFRIC SINGLE USE URINARY CATHETEREZDSubstantially Equivalent
K113003ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...NHASubstantially Equivalent
K112138ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANTNHASubstantially Equivalent
K111287ASTRA TECH IMPLANT SYSTEMDZESubstantially Equivalent
K101005ASTRA TECH IMPLANT SYSTEM, NEW COMPONENTNHASubstantially Equivalent
K110640ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENTNHASubstantially Equivalent
K110356ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENTNHASubstantially Equivalent
K103759ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANTNHASubstantially Equivalent
K101732ASTRA TECH IMPLANT SYSTEMDZESubstantially Equivalent
K101004ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENTNHASubstantially Equivalent
K093780ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENTNHASubstantially Equivalent
K093483ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENTNHASubstantially Equivalent
K091920ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBELNHASubstantially Equivalent
K091239ASTRA TECH IMPLANT SYSTEMDZESubstantially Equivalent
K083871ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONENHASubstantially Equivalent
K081666ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTSNHASubstantially Equivalent
K080156OSSEOSPEED TM PROFILE SYSTEMDZESubstantially Equivalent
K080396OSSEOSPEED NARROWDZESubstantially Equivalent
K072624ASTRA TECH IMPLANT SYSTEM, NEW COMPONENTNHASubstantially Equivalent
K063779OSSEOSPEED 4.0S-6MM, MODEL 24619DZESubstantially Equivalent
K053384FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEMDZESubstantially Equivalent
K050874ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETERGBMSubstantially Equivalent
K043241LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETERGBMSubstantially Equivalent
K041492ASTRA TECH IMPLANTS - DENTAL SYSTEMDZESubstantially Equivalent
K024111ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEEDDZESubstantially Equivalent
K023631ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTSNHASubstantially Equivalent
K012374MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETERGBMSubstantially Equivalent
K002513ASTRA TECH IMPLANTS - DENTAL SYSTEMDZESubstantially Equivalent
K990304MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEMDZESubstantially Equivalent
K991053ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)DZESubstantially Equivalent
K974738ASTRA TECH IMPLANT DENTAL SYSTEMDZESubstantially Equivalent
K974737ASTRA TECH IMPLANT DENTAL SYSTEMDZESubstantially Equivalent
K980698ASTRA TECH IMPLANTS - DENTAL SYSTEMDZESubstantially Equivalent
K931767ASTRA TECH IMPLANTS-DENTAL SYSTEMDZESubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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