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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iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered
#13K/TG DE Curette/Chisel #9Hdl
HU-FRIEDY MFG. CO., LLC
S13K/TG9
In Commercial Distribution

  • 10889950022563 ()
S13K/TG9

  • Periodontal file/rasp, manual
ERGOPERIO KIRKLAND CHISEL S13K/TG 190MM
Aesculap AG
DB030R
In Commercial Distribution

  • 04046964540165 ()
DB030R

  • Bone-coring punch, reusable
Periodontal Surgical chisel, TG, double ended
A. TITAN INSTRUMENTS, INC.
CTG
In Commercial Distribution

  • 00841685109080 ()


  • Dental osteotome
6.5mm TG Hex Abutment Impression Coping
TITAN IMPLANT INC
TN2-65TGHAIC
In Commercial Distribution

  • 00842448115614 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Titan Design TG Hex Abutment Driver
TITAN IMPLANT INC
TN-TGHAD
In Commercial Distribution

  • 00842448112613 ()


  • Dental implant system
TG PRO TACO ANKLE LG RIGHT
MEDI MANUFACTURING, INC.
501965
In Commercial Distribution

  • 00636257156889 ()


  • Ankle/foot orthosis
TG PRO TACO ANKLE SM RIGHT
MEDI MANUFACTURING, INC.
501963
In Commercial Distribution

  • 00636257156797 ()


  • Ankle/foot orthosis
TG PRO TACO ANKLE MD LEFT
MEDI MANUFACTURING, INC.
501954
In Commercial Distribution

  • 00636257156605 ()


  • Ankle/foot orthosis
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