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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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XCP-DS® Prosensor Kit. Contains: 8 Vertical Bitewings. XCP-DS® EVA: Plus 4 Horizontal Posterior Biteblocks, 4 Vertical Anterior Biteblocks. XCP-ORA®: Arm and Ring. XCP-DS®: Kodak 4 Horizontal Posterior Biteblocks, 4 Vertical Anterior Biteblocks, 8 Horizontal Bitewings with Biteblock. 1 Eezee-Grip. 50 Bulk Sensor Covers.
Dentsply International Inc.
553871
Not in Commercial Distribution

  • D0035538711 ()


  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
RINN® XCP-DS FIT® Carestream Kit
Dentsply International Inc.
553712
In Commercial Distribution

  • D0035537121 ()
553712

  • Dental x-ray film holder, reusable
XCP-ORA® Schick Elite Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® EVA Plus 8 Anterior Biteblocks, 8 Posterior Biteblocks, XCP-DS® Kodak 8 Horizontal Bitewings with Biteblock, 8 Vertical Bitewings with Biteblock, 50 Bulk Sensor Covers.
Dentsply International Inc.
552971
Not in Commercial Distribution

  • D0035529711 ()


  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
XCP-ORA® Dexis Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® Dexis 4 Horizontal Bitewings with Biteblocks, 4 Vertical Bitewings with Biteblocks. XCP-DS® Dexis 4 Posterior Biteblocks, 4 Anterior Biteblocks. 50 Bulk Sensor Covers.
Dentsply International Inc.
552571
Not in Commercial Distribution

  • D0035525711 ()


  • Dental x-ray film holder, reusable
XCP-DS® Sensor Positioning System for DEXIS Digital Sensors Contains: XCP-DS® 10 Biteblocks (2 Horizontal, 4 Vertical, 2 Anterior, 2 Posterior) 3 Arms (1 Endo Arm, 1 Anterior Arm, 2 Posterior), 5 Rings (1 Anterior Ring, 1 Endo, 2 Posterior), 5 Bulk Sensor Covers.
Dentsply International Inc.
552500
In Commercial Distribution

  • D0035525001 ()


  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
XCP-ORA® Sirona XIOS Plus. Contains: XCP-DS® Kodak 8 Vertical Anterior Biteblocks, XCP-DS® Kodak 8 Horizontal Posterior Biteblocks, XCP-DS® Kodak 8 Horizontal Bitewings with Biteblock, Schick Elite 8 Vertical Bitewings, XCP-ORA® Arm and Ring, 50 Bulk Sensor Covers.
Dentsply International Inc.
552160
Not in Commercial Distribution

  • D0035521601 ()


  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
XCP-ORA® Schick CDR Kit. Contains: 1 XCP-ORA® Arm and Ring. XCP-DS® 8 Horizontal Bitewings, 8 Vertical Bitewings. XCP-DS® 8 Vertical Anterior Biteblocks. XCP-DS® 8 Horizontal Posterior Biteblocks. 50 Bulk Sensor Covers.
Dentsply International Inc.
551971
Not in Commercial Distribution

  • D0035519711 ()


  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
RINN® XCP-ORA® Arm For DEXIS OEM Positioning Arm
Dentsply International Inc.
550776
Not in Commercial Distribution

  • D0035507761 ()
550776

  • Dental x-ray film holder, reusable
RINN® XCP-ORA® Positioning Arm For Stickybacks
Dentsply International Inc.
550775
In Commercial Distribution

  • D0035507751 ()
550775

  • Dental x-ray film holder, reusable
RINN® XCP-ORA® Positioning Arm
Dentsply International Inc.
550774
In Commercial Distribution

  • D0035507741 ()
550774

  • Dental x-ray film holder, reusable
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