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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Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00109
In Commercial Distribution

  • 10858395006513 ()
  • 00858395006516 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00108
In Commercial Distribution

  • 10858395006506 ()
  • 00858395006509 ()
GW-MOL-SC08

  • Dental delivery system instrument unit, electric
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00107
In Commercial Distribution

  • 10858395006490 ()
  • 00858395006493 ()
GW-MOL-SC07

  • Dental delivery system instrument unit, electric
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00106
In Commercial Distribution

  • 10858395006483 ()
  • 00858395006486 ()
GW-MOL-SC06

  • Dental delivery system instrument unit, electric
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00105
In Commercial Distribution

  • 10858395006476 ()
  • 00858395006479 ()
GW-MOL-SC05

  • Dental delivery system instrument unit, electric
No Description
QUANTA SYSTEM SPA
PLMS00125
Not in Commercial Distribution

  • 08033945934361 ()


  • Intense pulsed light skin surface treatment system
No Description
QUANTA SYSTEM SPA
PLMS00122
Not in Commercial Distribution

  • 08033945934354 ()


  • Intense pulsed light skin surface treatment system
No Description
BEAR DOWN CONSULTING
VT53WW4
In Commercial Distribution

  • 00817387026765 ()


  • Neurological visible-light phototherapy unit, home-use
No Description
BEAR DOWN CONSULTING
VT39WW1
In Commercial Distribution

  • 00817387026543 ()


  • Neurological visible-light phototherapy unit, home-use
No Description
BEAR DOWN CONSULTING
VT43CG3
In Commercial Distribution

  • 00817387025805 ()


  • Neurological visible-light phototherapy unit, home-use
No Description
BEAR DOWN CONSULTING
VT43MB3
In Commercial Distribution

  • 00817387025799 ()


  • Neurological visible-light phototherapy unit, home-use
No Description
BEAR DOWN CONSULTING
VT37WW1
In Commercial Distribution

  • 00817387024228 ()


  • Neurological visible-light phototherapy unit, home-use
1 OdneClean Device containing hose, metal rod holder, handpiece, multiple connection hoses, hose for disinfection, plug and cable, 500 sleeves, IFU / manual
Odne AG
E-0003
In Commercial Distribution

  • 07649988156632 ()
E-0003

  • Dental delivery system instrument unit, electric
Incubator, KVM Model 120, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
934090F
In Commercial Distribution

  • 10758750005352 ()
934090F

  • Microplate/tube/assay card incubator IVD
PREPSTART
DANVILLE MATERIALS, LLC
200259-00
In Commercial Distribution

  • 00816594021785 ()
200259-00

  • Dental abrasive air jet system control unit
PREPAIR
DANVILLE MATERIALS, LLC
200782
In Commercial Distribution

  • 00816594021778 ()
200782

  • Dental abrasive air jet system control unit
No Description
BEAR DOWN CONSULTING
VT54WW6
In Commercial Distribution

  • 00810115633235 ()


  • Neurological visible-light phototherapy unit, home-use
Built-in Component
W & H Dentalwerk Bürmoos GmbH
30363000
In Commercial Distribution

  • J021303630000 ()
  • J021303630001 ()


  • Dental delivery system instrument unit, electric
Built-in Component
W & H Dentalwerk Bürmoos GmbH
30358000
In Commercial Distribution

  • J021303580000 ()
  • J021303580001 ()


  • Dental delivery system instrument unit, electric
Built-in Component
W & H Dentalwerk Bürmoos GmbH
30353000
In Commercial Distribution

  • J021303530000 ()
  • J021303530001 ()


  • Dental delivery system instrument unit, electric
Built-in Component
W & H Dentalwerk Bürmoos GmbH
30348000
In Commercial Distribution

  • J021303480001 ()
  • J021303480000 ()


  • Dental delivery system instrument unit, electric
Built-in Component
W & H Dentalwerk Bürmoos GmbH
30347000
In Commercial Distribution

  • J021303470001 ()
  • J021303470000 ()


  • Dental delivery system instrument unit, electric
Built-in Component
W & H Dentalwerk Bürmoos GmbH
30344000
In Commercial Distribution

  • J021303440001 ()
  • J021303440000 ()


  • Dental delivery system instrument unit, electric
Engler Dental Unit Drill Aire Mini
DCI International, LLC
4751
In Commercial Distribution

  • 00810021436852 ()
4751

  • Dental delivery system instrument unit, electric
Engler Dental Unit Drill Aire Mini Plus
DCI International, LLC
4752
In Commercial Distribution

  • 00810021436845 ()
4752

  • Dental delivery system instrument unit, electric
12 O'Clock Floor Mount Delivery Series 5
DCI International, LLC
DR5
In Commercial Distribution

  • 00810021435275 ()


  • Dental delivery system instrument unit, electric
Ortho Cabinet
DCI International, LLC
CZ1
In Commercial Distribution

  • 00810021435268 ()


  • Dental delivery system instrument unit, electric
Engler Dental Unit Manual 1 Wet
DCI International, LLC
4750
In Commercial Distribution

  • 00810021434957 ()
4750

  • Dental delivery system instrument unit, electric
Automatic Control Unit
DCI International, LLC
ACU
In Commercial Distribution

  • 00810021432946 ()


  • Dental delivery system instrument unit, electric
Reliance Automatic Control Cart
DCI International, LLC
ACC Reliance
In Commercial Distribution

  • 00810021432588 ()


  • Dental delivery system instrument unit, electric
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