Medical Device Manufacturer · US , Amherst , NY

Ivoclar North America, Inc.

131 submissions · 131 cleared · Since 1989
131
Total
131
Cleared
0
Denied

Ivoclar North America, Inc. — FDA 510(k) Submissions

Ivoclar North America, Inc. has submitted 131 FDA 510(k) premarket notifications since 1989, of which 131 received clearance as substantially equivalent to a predicate device.

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

131 devices
1–25 of 131
ERIS LAYERING MATERIALS
K012174 · EIH Powder, Porcelain · Dental
Aug 2001 46d
HELIOSEAL CLEAR CHROMA
K011491 · EBC Sealant, Pit And Fissure,... · Dental
Aug 2001 93d
IN TEN-S
K011492 · EBF Material, Tooth Shade, Resin · Dental
Jul 2001 51d
MODIFICATION TO EXCITE
K011490 · KLE Agent, Tooth Bonding, Resin · Dental
Jun 2001 43d
BIOUNIVERSAL PDF
K011022 · EJT Alloy, Gold-based Noble... · Dental
May 2001 28d
D.SIGN 96
K011023 · EJT Alloy, Gold-based Noble... · Dental
May 2001 28d
D.SIGN 30
K010381 · EJH Alloy, Metal, Base · Dental
Mar 2001 26d
TETRIC CERAM HB
K010250 · EBF Material, Tooth Shade, Resin · Dental
Feb 2001 33d
EXCITE DSC
K003293 · KLE Agent, Tooth Bonding, Resin · Dental
Feb 2001 109d
SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)
K003407 · EMA Cement, Dental · Dental
Jan 2001 86d
DW 276 #3
K003635 · EJT Alloy, Gold-based Noble... · Dental
Dec 2000 28d
DW 272 #1
K003634 · EJT Alloy, Gold-based Noble... · Dental
Dec 2000 27d
DW 273 #1
K003632 · EJS Alloy, Other Noble Metal · Dental
Dec 2000 26d
DW 277 #4
K003633 · EJT Alloy, Gold-based Noble... · Dental
Dec 2000 26d
FERMIT PLUS
K003374 · EBG Crown And Bridge,... · Dental
Dec 2000 35d
FERMIT N PLUS
K003377 · EBG Crown And Bridge,... · Dental
Dec 2000 35d
PROCAD ADD-ON
K003373 · EIH Powder, Porcelain · Dental
Nov 2000 29d
R&D PROJECT DW271#11A
K002872 · EJT Alloy, Gold-based Noble... · Dental
Nov 2000 49d
R&D PROJECT DW269#25
K001469 · EJS Alloy, Other Noble Metal · Dental
Jul 2000 56d
TETRIC FLOW
K993783 · EBF Material, Tooth Shade, Resin · Dental
Dec 1999 35d
IPS D.SIGN PORCELAIN
K990817 · EIH Powder, Porcelain · Dental
Apr 1999 26d
EXCITE
K990534 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 1999 28d
MONOPAQUE
K990315 · EBF Material, Tooth Shade, Resin · Dental
Mar 1999 31d
D-SIGN V (R&D PROJECT DW267#17)
K990182 · EJH Alloy, Metal, Base · Dental
Mar 1999 40d
D-SIGN VI (R&D PROJECT DW266#9)
K990235 · EJH Alloy, Metal, Base · Dental
Mar 1999 35d

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