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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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PDT, Inc. - 00813677024947

Kit Includes: (T009D-L) D-Series FlipTop™ Cassette - LiftOut Rack 9 (R138) Montana Jack® (R166) 5 Explorer (R245) Cone Socket Mirror Handle (R375) Mixing Spatula-Applicator (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium
PDT, INC.
R933 PDT Cement (Crown Seating) Kit
In Commercial Distribution

  • 00813677024947 ()
R933

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental spatula, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe

PDT, Inc. - 00813677025005

Kit Includes: (R006) 11-12 Amazing Gracey™ Extended Reach Mini (R007) 13-14 Amazing Gracey™ Extended Reach Mini (R064) Columbia 13-14 (R130S) Jack B. Nimble® (R138) Montana Jack® (R224) 23 Explorer-Williams O Probe (R245) Cone Socket Mirror Handle (T050) #5 Mirror (15/16")
PDT, INC.
R971 Just Be Nice Hygiene Kit
In Commercial Distribution

  • 00813677025005 ()
R971

  • Dental mirror, reusable
  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle

PDT, Inc. - 00813677024848

Kit Includes: T007B-D B-Series FlipTop™ Cassette - Double Rack 14 R067 Columbia 4L-4R R080 Langer 3-4 R090 H5-L5 R138 Montana Jack® R167 11-12 ODU Explorer R216 ACE™-12 Short Probe R245 Cone Socket Mirror Handle T040 Cotton Pliers T050 #5 Mirror (15/16")
PDT, INC.
R915 PDT SRP C Kit
In Commercial Distribution

  • 00813677024848 ()
R915

  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental mirror, reusable

F-Scan GO - B970FG20

Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 In-Shoe Pressure Measurement Software, 2 Velcro Ankle Bands, 20 In-Shoe Sensors (model 3010-125), 2 Li-Ion Battery Packs, 2 Battery Chargers, 2 USB-C to USB-A cables, Wireless Router, Quick Start Guide, System Carrying Case and 1 On-line Training Session (USA Only)
Tekscan, Inc.
F-Scan GO System
In Commercial Distribution

  • B970FG20 ()
FG2

  • Body-surface pressure mapping system

PDT, Inc. - 00813677024473

Kit Includes: T009D-F FlipTop™ Cassette 'D' - Fixed Rack 9 R245 Mirror Handle (Cone-Socket) T050 #5 Front Surface Mirror, Cone-Socket, (15/16') R166 Explorer 5 R138R Montana Jack® Rigid R375 Mixing Spatula/Applicator T046 Articulating paper forceps MILLER T235 Aspirating Anesthetic Syringe Medium T040 Tweezers COLLEGE T319 Bur Block
PDT, INC.
R981 Cement Kit
In Commercial Distribution

  • 00813677024473 ()
R981

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental spatula, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe

F-Scan GO - B970FG2PRO0

Includes 2 TekDAQ 200 Wi-Fi Wearable Sensor Acquisition Units, FootVIEW 10.0 Pro In-Shoe Pressure Measurement Software, 2 Velcro Ankle Bands, 20 In-Shoe Sensors (model 3010-125), 4 Li-Po Battery Packs, 2 Battery Chargers, 2 USB-C to USB-A cables, Wireless Router, Quick Start Guide, System Carrying Case and 1 On-line Training Session (USA Only)
Tekscan, Inc.
F-Scan GO System with FootVIEW Pro
In Commercial Distribution

  • B970FG2PRO0 ()
FG2PRO

  • Body-surface pressure mapping system

PDT, Inc. - 00813677024992

Kit Includes: (T007B-F) B-Series FlipTop™ Cassette - Fixed Rack 7 (R006) 11-12 Amazing Gracey™ Extended Reach Mini (R007) 13-14 Amazing Gracey™ Extended Reach Mini (R064) Columbia 13-14 (R130S) Jack B. Nimble® (R138) Montana Jack® (R224) 23 Explorer-Williams O Probe (R245) Cone Socket Mirror Handle (T050) #5 Mirror (15/16")
PDT, INC.
R970 Just Be Nice Hygiene Kit with Cassette
In Commercial Distribution

  • 00813677024992 ()
R970

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle

PDT, Inc. - 00813677024831

Kit Includes: T009C-D C-Series FlipTop™ Cassette - Double Rack 18 R061 Barnhart 5-6 R080 Langer 3-4 R130S Jack B. Nimble® Slim R138 Montana Jack® R144 Queen of Hearts™ R167 11-12 ODU Explorer R223 23 Explorer-12 Probe R245 Cone Socket Mirror Handle T043 Cotton Pliers T050 #5 Mirror (15/16”)
PDT, INC.
R913 PDT I Dream of Hygiene™ Kit
In Commercial Distribution

  • 00813677024831 ()
R913

  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental mirror, reusable

PDT, Inc. - 00813677024862

Kit Includes: T009C-F C-Series FlipTop™ Cassette - Fixed Rack 9 R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R130 Jack B. Nimble® R138 Montana Jack® R144 Queen of Hearts™ R167 11-12 ODU Explorer R195 Probe 12 (3-6-9-12) R245 Cone Socket Mirror Handle T050 #5 Mirror (15/16")
PDT, INC.
R917 PDT Amazing Gracey™ Prophy Kit
In Commercial Distribution

  • 00813677024862 ()
R917

  • Dental mirror, reusable
  • Manual dental scaler, reusable
  • Periodontal curette
  • Dental surgical probe, reusable
  • Instrument tray, reusable
  • Manual non-rotary dental instrument handle

PDT, Inc. - 00813677025142

Kit Includes: R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R093 N128-L5 Mini R096 N1 R130S Jack B. Nimble® Slim Scaler R135 204S R138 Montana Jack® R166 Explorer 5 R167 Explorer ODU 11-12 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) T009D-F15 FlipTop™ Cassette 'D' - Fixed Rack 15 T055 Double-Sided PrecisionReflect HD
PDT, INC.
R985 Rev B Andy RDH Student Kits
In Commercial Distribution

  • 00813677025142 ()
R983 Rev C

  • Periodontal curette
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Instrument tray, reusable
  • Dental mirror, reusable
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