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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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Advanced Endodontic System - 00850309007305

Advanced Endodontic System
ASI MEDICAL, INC.
90-2134E/C
In Commercial Distribution

  • 00850309007305 ()
90-2134E/C

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007299

Advanced Dental System
ASI MEDICAL, INC.
90-2134D/C
In Commercial Distribution

  • 00850309007299 ()
90-2134D/C

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007282

Advanced Endodontic System
ASI MEDICAL, INC.
90-2134E
In Commercial Distribution

  • 00850309007282 ()
90-2134E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007275

Advanced Dental System
ASI MEDICAL, INC.
90-2134D
In Commercial Distribution

  • 00850309007275 ()
90-2134D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007268

Advanced Endodontic System
ASI MEDICAL, INC.
90-2133E
In Commercial Distribution

  • 00850309007268 ()
90-2133E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007251

Advanced Dental System
ASI MEDICAL, INC.
90-2133D
In Commercial Distribution

  • 00850309007251 ()
90-2133D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007244

Advanced Endodontic System
ASI MEDICAL, INC.
90-2143E
In Commercial Distribution

  • 00850309007244 ()
90-2143E

  • Dental delivery system instrument unit, electric

Advanced Dental System - 00850309007237

Advanced Dental System
ASI MEDICAL, INC.
90-2143D
In Commercial Distribution

  • 00850309007237 ()
90-2143D

  • Dental delivery system instrument unit, electric

Advanced Endodontic System - 00850309007220

Advanced Endodontic System
ASI MEDICAL, INC.
90-2140E
In Commercial Distribution

  • 00850309007220 ()
90-2140E

  • Dental delivery system instrument unit, electric

Vitalcontrol - 00852547004498

Light based, over the counter device intended for the removal of unwanted hair as well as permanent reduction in hair regrowth.
BEURER NORTH AMERICA, L.P.
IPL100 (Art.-No. 575.40)
In Commercial Distribution

  • 10852547004495 ()
  • 00852547004498 ()
Art.-No. 575.40

  • Intense pulsed light skin surface treatment system

A-dec - 10194665007300

A-dec CART343pro Cart Delivery System
A-DEC, INC.
343pro
In Commercial Distribution

  • 10194665007300 ()
343pro

  • Dental delivery system instrument unit, electric

WORLD AESTHETIX BROAD PULSED LIGHT - 00850062978003

The World Aesthetix Broad Pulsed Light device is indicated for use in surgical, aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
WORLD AESTHETIX LLC
WAX161286
Not in Commercial Distribution

  • 00850062978003 ()


  • Intense pulsed light skin surface treatment system

SCALEX - 00858466005165

Ultrasonic Scaler
DENTAMERICA, INC.
170
In Commercial Distribution

  • 00858466005165 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005158

Ultrasonic Scaler
DENTAMERICA, INC.
173
In Commercial Distribution

  • 00858466005158 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005141

Ultrasonic Scaler
DENTAMERICA, INC.
890
In Commercial Distribution

  • 00858466005141 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005134

Ultrasonic Scaler
DENTAMERICA, INC.
850
In Commercial Distribution

  • 00858466005134 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005127

Ultrasonic Scaler
DENTAMERICA, INC.
880P
In Commercial Distribution

  • 00858466005127 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005110

Ultrasonic Scaler
DENTAMERICA, INC.
830
In Commercial Distribution

  • 00858466005110 ()


  • Dental delivery system instrument unit, electric

SCALEX - 00858466005103

Ultrasonic Scaler
DENTAMERICA, INC.
800
In Commercial Distribution

  • 00858466005103 ()


  • Dental delivery system instrument unit, electric

Premolar CrossFire Procedure Instrument with Matrix - 00858395006653

Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on the premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-014-00001
In Commercial Distribution

  • 00858395006646 ()
  • 00858395006653 ()
GW-PRE-XF10

  • Dental delivery system instrument unit, electric
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