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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-ORA® RVG 6100. Contains: XCP-DS® Kodak 8 Horizontal Bitewings with Biteblocks, 8 Vertical Bitewings with Biteblocks. XCP-DS® Kodak 8 Horizontal Posterior Biteblocks, XCP-DS® Kodak 8 Vertical Anterior Biteblocks, XCP-ORA® Arm and Ring, 50 Bulk Sensor Covers.
Dentsply International Inc.
553071
Not in Commercial Distribution

  • D0035530711 ()


  • Dental x-ray film holder, reusable
  • Medical equipment/instrument drape, single-use
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® Universal Digital Sensor Covers, 500-pk
Dentsply International Inc.
550500
In Commercial Distribution

  • D0035505001 ()
  • D0035505000 ()


  • Medical equipment/instrument drape, single-use
Uni-Grip® 360, Universal Sensor Holder. Contains: 100 Sensor Holders, 100 Sensor Covers, Uni-GripAR® Positioning Arm and Ring
Dentsply International Inc.
550252
In Commercial Distribution

  • D0035502521 ()


  • Dental x-ray film holder, reusable
  • Cable/lead/sensor/probe cover, non-sterile
Rinn® Large Digital Sensor Covers, 200-pk
Dentsply International Inc.
550200
In Commercial Distribution

  • D0035502001 ()
  • D0035502000 ()


  • Cable/lead/sensor/probe cover, non-sterile
RINN® Tight Sensor Covers – Size 1, Box of 300.
Dentsply International Inc.
550149
In Commercial Distribution

  • D0035501491 ()
  • D0035501490 ()


  • Cable/lead/sensor/probe cover, non-sterile
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