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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Cinch™ - M595S463S0

Quick Cinch™ Heavy Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S463S
Not in Commercial Distribution

  • M595S463S1 ()
  • M595S463S0 ()
S463S

  • Silicone dental impression material

Cinch™ - M595S461S0

Quick Cinch™ Light-Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S461S
Not in Commercial Distribution

  • M595S461S1 ()
  • M595S461S0 ()
S461S

  • Silicone dental impression material

Cinch™ - M595S460S0

Cinch™ Light Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S460S
Not in Commercial Distribution

  • M595S460S1 ()
  • M595S460S0 ()
S460S

  • Silicone dental impression material

Blu-Mousse® - M595S457S0

Super-Fast Blu-Mousse® Split-Cartridge System
PARKELL, INC.
S457S
Not in Commercial Distribution

  • M595S457S1 ()
  • M595S457S0 ()
S457S

  • Silicone dental impression material

Blu-Mousse® - M595S4570

Super-Fast Blu-Mousse® Standard-Cartridge System
PARKELL, INC.
S457
Not in Commercial Distribution

  • M595S4571 ()
  • M595S4570 ()
S457

  • Silicone dental impression material

Green-Mousse® - M595S455S0

Green-Mousse® In Split-Cartridge System
PARKELL, INC.
S455S
Not in Commercial Distribution

  • M595S455S1 ()
  • M595S455S0 ()
S455S

  • Silicone dental impression material

Cinch™ - M595S454S0

Cinch™ Platinum Medium Body In Split-Cartridge No Clog Auto Mix System (4-Cartridges & Tips)
PARKELL, INC.
S454S
Not in Commercial Distribution

  • M595S454S1 ()
  • M595S454S0 ()
S454S

  • Silicone dental impression material

Cinch™ - M595S453S0

Cinch™ 90 Medium-Body Split-Cartridge System (4-Cartridges & Tips)
PARKELL, INC.
S453S
Not in Commercial Distribution

  • M595S453S1 ()
  • M595S453S0 ()
S453S

  • Silicone dental impression material

Cinch™ - M595S4350

Cinch™ Platinum Tubes (Contains: 2-Tubes Base & 2-Tubes Catalyst)
PARKELL, INC.
S435
Not in Commercial Distribution

  • M595S4351 ()
  • M595S4350 ()
S435

  • Silicone dental impression material

AMALGAMBOND® - M595S3760

‘HPA’ Powder AMALGAMBOND®
PARKELL, INC.
S376
Not in Commercial Distribution

  • M595S3760 ()
S376

  • Dentine bonding agent/set
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