510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Jeneric/Pentron, Inc.

Wallingford, CT, US

Jeneric/Pentron, Inc. appears in FDA device records in Wallingford, CT. FDA records list 78 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
78
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

Showing 50 of 78

FDA records hold 78 510(k) clearances for Jeneric/Pentron, Inc. between 1988 and 2002. The busiest year on record is 2000, with 13. The most recent is 2002, with 3.

Clearances by year, as a table
510(k) clearance decisions for Jeneric/Pentron, Inc., by decision year
YearClearances
19882
19895
19901
19912
19927
19937
199412
19956
19962
19974
19982
19994
200013
20018
20023
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K020499BOND-3 ADHESIVEKLESubstantially Equivalent
K013543BOND-1 C & BKLESubstantially Equivalent
K013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)KLESubstantially Equivalent
K012231AVANTE MICRO CRYSTAL SYSTEMEIHSubstantially Equivalent
K011748FIRST FILL R.C.S.KIFSubstantially Equivalent
K010957QUELL DESENSITIZERLBHSubstantially Equivalent
K011331JP CAST 40EJTSubstantially Equivalent
K011330JP CAST 50EJTSubstantially Equivalent
K011362GOLD CORE 73 LSEJTSubstantially Equivalent
K010044COSMICEJTSubstantially Equivalent
K003683AVANTE CURELIGHTEBZSubstantially Equivalent
K002854GOLD CORE POST SOLDEREJTSubstantially Equivalent
K002815GOLD CORE HF PRE SOLDEREJTSubstantially Equivalent
K003039GOLD CORE IIEJHSubstantially Equivalent
K003037JEWEL CAST IIIEJHSubstantially Equivalent
K003011SELF ETCH BONDING PRIMERKLESubstantially Equivalent
K001623SCULPTURE FLOWEBFSubstantially Equivalent
K001218CORRECT PLUSELWSubstantially Equivalent
K001051RX EVERESTEJTSubstantially Equivalent
K994359BOND 1 C & BKLESubstantially Equivalent
K000211BUILD-IT FREBFSubstantially Equivalent
K000173CEMENT IT! UNIVERSAL C&BEMASubstantially Equivalent
K000360RX G-UNIVERSALEJTSubstantially Equivalent
K994435OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINSEIHSubstantially Equivalent
K993249OPC LOW WEAR OPAQUE PORCELAINEIHSubstantially Equivalent
K993175GOLD CORE 75EJTSubstantially Equivalent
K993173GOLD CORE 55EJTSubstantially Equivalent
K991901BIO-97EJTSubstantially Equivalent
K983266FIBREKOR POST SYSTEMELRSubstantially Equivalent
K982377OPC LOWWEAR PORCELAINEIHSubstantially Equivalent
K974131ALERTEBFSubstantially Equivalent
K972985SPLINT ITELSSubstantially Equivalent
K973388DENTIN CONDITIONING AND ADHESIVE (BOND 1)KLESubstantially Equivalent
K970941SLIPPERY GLASSEIHSubstantially Equivalent
K964578FIBREKOREBFSubstantially Equivalent
K963891RX 96EEJHSubstantially Equivalent
K953642AP-18JEHSubstantially Equivalent
K953381PROP. CONQUEST C&B VLC GLAZE/SEALANTEBISubstantially Equivalent
K953859BOND-IT DUAL CURE ACTIVATORKLESubstantially Equivalent
K952662COMP=FLOWEBFSubstantially Equivalent
K952240TOOTH PREPARATION CONDITIONER, PRE-IMPRESSIONEBCSubstantially Equivalent
K952500COMPSEALEBFSubstantially Equivalent
K945401WHITE STAREJTSubstantially Equivalent
K944084JENERIC/PENTRON P0WERED TOOTHBRUSTJEQSubstantially Equivalent
K943487BIO74-PF CROWN & BRIDGE ALLOYEJTSubstantially Equivalent
K941377CONQUEST SMOOTH TOUCHEBFSubstantially Equivalent
K941373PENT CORE PLUS (PASTE-PASTE)EBFSubstantially Equivalent
K941378PROCOMEBFSubstantially Equivalent
K941376CONQUEST SENIOREBFSubstantially Equivalent
K941375CONQUEST GINGA-BLENDEBFSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0482-2010TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.Terminated

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.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Jeneric/Pentron, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

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