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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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No Description
U&C International Co.,Ltd
R2iCE Zirconia Block AT A3 98 * 12T
In Commercial Distribution

  • 08800118607540 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
R2iCE Zirconia Block AT A2 98 * 30T
In Commercial Distribution

  • 08800118607533 ()


  • Dental appliance fabrication material, ceramic
DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights. Retentive caps, metal housing for the caps, directional rings and protective disc.
RHEIN 83 SRL
SPHERO FLEX STRAUMANN AT h.2 TiN
In Commercial Distribution

109BFTAT2R

  • Dental implant suprastructure, permanent, preformed
Periodontics for the premolar and molar sectors, left-oriented First instrument in the sequence for treating all the surfaces and the furcations. • Maxillary: buccal and distal surfaces of sector 2, pivots at 13, then the buccal and mesial surfaces of sector 1. • Mandibular: buccal and distal surfaces of sector 4, pivots at 43, then lingual and mesial surfaces of sector 3.
SATELEC
TIP H4L
In Commercial Distribution

  • 03609820001142 ()
F00114

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
CUSTOM MASTER SET PLUS
DENTALEZ, INC.
264383
Not in Commercial Distribution

  • D7022643830 ()


  • Pneumatic dental scaling/debridement system
  • Dental surgical power tool motorized handpiece/set, pneumatic
Deziree's Hygiene Solution
DENTALEZ, INC.
263996
Not in Commercial Distribution

  • D7022639960 ()


  • Pneumatic dental scaling/debridement system
  • Dental surgical power tool motorized handpiece/set, pneumatic
Adaptor for Instrument Channel
Karl Storz GmbH & Co. KG
28400V
In Commercial Distribution

  • 04048551112304 ()


  • Endoscope inflation bulb adaptor
The CyclaPlex Drill Guide is a “H arm” device intended to guide drill bits at the right points and required drilling angles in the 1st and 2nd metatarsal bones.
ALPHAMET LTD
V7
In Commercial Distribution

  • 07290017626192 ()
DG-9201

  • Orthopaedic implant aiming/guiding block attachment tool
The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
10028871
In Commercial Distribution

  • 00812101030769 ()
10028871

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL.
ARK DIAGNOSTICS INC
5055-0001-01
In Commercial Distribution

  • 00812101030356 ()
5055-0001-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
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