Medical Device Manufacturer · US , Wallingford , CT

Jeneric/Pentron, Inc.

78 submissions · 78 cleared · Since 1988
78
Total
78
Cleared
0
Denied

Jeneric/Pentron, Inc. — FDA 510(k) Submissions

Jeneric/Pentron, Inc. has submitted 78 FDA 510(k) premarket notifications since 1988, of which 78 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Alloy, Gold-based Noble Metal, Alloy, Other Noble Metal, Agent, Tooth Bonding, Resin, Alloy, Metal, Base . Use the specialty filter in the sidebar to narrow results.

78 devices
1–25 of 78
BOND-3 ADHESIVE
K020499 · KLE Agent, Tooth Bonding, Resin · Dental
Apr 2002 67d
BOND-1 C & B
K013543 · KLE Agent, Tooth Bonding, Resin · Dental
Feb 2002 128d
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
K013542 · KLE Agent, Tooth Bonding, Resin · Dental
Feb 2002 120d
AVANTE MICRO CRYSTAL SYSTEM
K012231 · EIH Powder, Porcelain · Dental
Aug 2001 38d
FIRST FILL R.C.S.
K011748 · KIF Resin, Root Canal Filling · Dental
Aug 2001 58d
QUELL DESENSITIZER
K010957 · LBH Varnish, Cavity · Dental
Jun 2001 87d
JP CAST 50
K011330 · EJT Alloy, Gold-based Noble... · Dental
Jun 2001 51d
JP CAST 40
K011331 · EJT Alloy, Gold-based Noble... · Dental
Jun 2001 51d
GOLD CORE 73 LS
K011362 · EJT Alloy, Gold-based Noble... · Dental
May 2001 26d
COSMIC
K010044 · EJT Alloy, Gold-based Noble... · Dental
Feb 2001 35d
AVANTE CURELIGHT
K003683 · EBZ Activator, Ultraviolet,... · Dental
Jan 2001 43d
GOLD CORE POST SOLDER
K002854 · EJT Alloy, Gold-based Noble... · Dental
Dec 2000 100d
GOLD CORE HF PRE SOLDER
K002815 · EJT Alloy, Gold-based Noble... · Dental
Dec 2000 99d
JEWEL CAST III
K003037 · EJH Alloy, Metal, Base · Dental
Dec 2000 67d
GOLD CORE II
K003039 · EJH Alloy, Metal, Base · Dental
Dec 2000 67d
SELF ETCH BONDING PRIMER
K003011 · KLE Agent, Tooth Bonding, Resin · Dental
Nov 2000 63d
SCULPTURE FLOW
K001623 · EBF Material, Tooth Shade, Resin · Dental
Jul 2000 46d
CORRECT PLUS
K001218 · ELW Material, Impression · Dental
Jul 2000 79d
RX EVEREST
K001051 · EJT Alloy, Gold-based Noble... · Dental
Apr 2000 25d
BOND 1 C & B
K994359 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 2000 85d
BUILD-IT FR
K000211 · EBF Material, Tooth Shade, Resin · Dental
Mar 2000 53d
CEMENT IT! UNIVERSAL C&B
K000173 · EMA Cement, Dental · Dental
Feb 2000 40d
RX G-UNIVERSAL
K000360 · EJT Alloy, Gold-based Noble... · Dental
Feb 2000 14d
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
K994435 · EIH Powder, Porcelain · Dental
Feb 2000 42d
OPC LOW WEAR OPAQUE PORCELAIN
K993249 · EIH Powder, Porcelain · Dental
Nov 1999 62d

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