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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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TELEA ELECTRONIC ENGEENERING SRL
D=0,17mm b=10mm h=10mm L=110mm
In Commercial Distribution

  • 08034055292419 ()
  • 18034055292419 ()
2603043

  • Open-surgery electrosurgical electrode, monopolar, reusable
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
Kit Includes: R144 Queen of Hearts™ R138BC Montana Jack® (Breast Cancer Pink) R120 Montana 4-5™ Scaler R044 Amazing Gracey™ 15-16 Extended Reach R043 Amazing Gracey™ 13-14 Extended Reach R093 N128-L5 Mini R067 Columbia 4L-4R T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7
PDT, INC.
R976 Perio Maintenance Kit
In Commercial Distribution

  • 00813677024442 ()
R976

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
Kit Includes: R144 Queen of Hearts™ R138BC Montana Jack® (Breast Cancer Pink) R120 Montana 4-5™ Scaler R044 Amazing Gracey™ 15-16 Extended Reach R043 Amazing Gracey™ 13-14 Extended Reach R093 N128-L5 Mini R067 Columbia 4L-4R T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7
PDT, INC.
R975 SRP Kit
In Commercial Distribution

  • 00813677024435 ()
R975

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SPHERO B/MICRO INTEGRAL ø 4 h.4 TiN
Not in Commercial Distribution

  • D821003CLK44R0 ()


  • Dental implant suprastructure, permanent, preformed
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SPHERO B/MICRO INTEGRAL ø 4 h.3 TiN
Not in Commercial Distribution

  • D821003CLK43R0 ()
003CLK43R

  • Dental implant suprastructure, permanent, preformed
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SPHERO B/NORMO INDEX ø 3,4 h.4 TiN
Not in Commercial Distribution

  • D821002INLK334R0 ()
002INLK334R

  • Dental implant suprastructure, permanent, preformed
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SPHERO B/NORMO INDEX ø 3,4 h.2 TiN
Not in Commercial Distribution

  • D821002INLK332R0 ()
002INLK332R

  • Dental implant suprastructure, permanent, preformed
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S/ B/NORMO ENDURE Imtec ø 3,5-4,3 h.3TiN
Not in Commercial Distribution

  • D821002ENI433R0 ()


  • Dental implant suprastructure, permanent, preformed
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S/ B/NORMO ENDURE Imtec ø 3,5-4,3 h.1TiN
Not in Commercial Distribution

  • D821002ENI431R0 ()
002ENI431R

  • Dental implant suprastructure, permanent, preformed
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