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

Bavaria D-82228 Seefeld, DE

Espe Dental AG appears in FDA device records in Bavaria D-82228 Seefeld, DE. FDA records list 29 510(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
29
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 29 510(k) clearances for Espe Dental AG between 1998 and 2001. The busiest year on record is 1999, with 16. The most recent is 2001, with 2.

Clearances by year, as a table
510(k) clearance decisions for Espe Dental AG, by decision year
YearClearances
19981
199916
200010
20012
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K011394LAVA FRAME, LAVA FRAME SHADE, LAVA CERAMEIHSubstantially Equivalent
K011154ELIPAR FREELIGHTEBZSubstantially Equivalent
K002793KETAC CEM UEMASubstantially Equivalent
K002364PROTEMP HEBGSubstantially Equivalent
K001494MODIFICATION TO PROMPT L-POPKLESubstantially Equivalent
K000595DIMENSION PENTA LELWSubstantially Equivalent
K000591DIMENSION PENTA H, DIMENSION PENTA H QUICKELWSubstantially Equivalent
K000588DIMENSION GARANT L, DIMENSION GARANT L QUICKELWSubstantially Equivalent
K994193IMPREGUM PENTA DUOSOFTELWSubstantially Equivalent
K994192IMPREGUM PENTA M MONOSOFTELWSubstantially Equivalent
K994190IMPREGUM GARANT L DUOSOFTELWSubstantially Equivalent
K994251KETAC-MOLAR QUICKEBFSubstantially Equivalent
K993566PROMPTFLOWEBFSubstantially Equivalent
K992909HYTACEBFSubstantially Equivalent
K992966REFERENCEEBFSubstantially Equivalent
K992645SINFONYEBFSubstantially Equivalent
K992897IMPREGUM PENTAELWSubstantially Equivalent
K992895IMPREGUM FELWSubstantially Equivalent
K992048MODIFICATION OF PROMPT L-POPKLESubstantially Equivalent
K991913PENTAMIX 2EFDSubstantially Equivalent
K991008DIMENSION BITEELWSubstantially Equivalent
K990763VITRON MEBISubstantially Equivalent
K991221VESTOGUMELWSubstantially Equivalent
K991220VITRON HEBISubstantially Equivalent
K990982CAVIT LCEBFSubstantially Equivalent
K984247ELIPAR TRILIGHTEBZSubstantially Equivalent
K984248PROCEMEMASubstantially Equivalent
K984246PROMPT L-POPKLESubstantially Equivalent
K983414EVERBONDKLESubstantially 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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