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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Aquasil Ultra+ Soft Putty in DECA Delivery, Regular Set
DENTSPLY INTERNATIONAL INC.
678622
Not in Commercial Distribution

  • D0026786220 ()
  • D0026786221 ()
678622

  • Silicone dental impression material
Aquasil Ultra Heavy FS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678276
In Commercial Distribution

  • D0026782760 ()
  • D0026782761 ()
678276

  • Silicone dental impression material
Aquasil Ultra Heavy RS Cartridge Bulk Refill
DENTSPLY INTERNATIONAL INC.
678275
In Commercial Distribution

  • D0026782750 ()
  • D0026782751 ()
678275

  • Silicone dental impression material
Aquasil Ultra digit LV & XLV Fast Set Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678032
Not in Commercial Distribution

  • D0026780321 ()
678032

  • Silicone dental impression material
Aquasil Ultra digit LV & XLV Regular Set Evaluator Kit
DENTSPLY INTERNATIONAL INC.
678031
Not in Commercial Distribution

  • D0026780311 ()
678031

  • Silicone dental impression material
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is Part B of the two part system
RELIANCE ORTHODONTIC PRODUCTS INC
CIQB
Not in Commercial Distribution

  • D798CIQB0 ()
CIQB

  • Dentine bonding agent/set
3M™ Impregum™ Penta™ Super Quick MB Introductory Kit Dual, 69414
3M Deutschland GmbH
69414
In Commercial Distribution

  • 04054596582620 ()
69414

  • Dental material mixing nozzle
  • Gingival retraction kit
  • Dental material injection cannula, single-use
  • Polyether dental impression material
  • Dental impression material adhesive
  • Dental impression material mixer
3M™ Impregum™ Penta™ Super Quick MB/LB Introductory Kit Dual, 69415
3M Deutschland GmbH
69415
In Commercial Distribution

  • 04054596582477 ()
69415

  • Dental material injection cannula, single-use
  • Dental impression material adhesive
  • Dental material mixing nozzle
  • Polyether dental impression material
  • Dental impression material mixer
  • Gingival retraction kit
3M™ Impregum™ Penta™ Super Quick HB/LB Introductory Kit Dual, 69407
3M Deutschland GmbH
69407
In Commercial Distribution

  • 04054596582514 ()
69407

  • Gingival retraction kit
  • Dental material injection cannula, single-use
  • Polyether dental impression material
  • Dental impression material adhesive
  • Dental impression material mixer
  • Dental material mixing nozzle
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.
RELIANCE ORTHODONTIC PRODUCTS INC
CIQA
Not in Commercial Distribution

  • D798CIQA0 ()
CIQA

  • Dentine bonding agent/set
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