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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Non-stick silicone for acrylics, with suction base. Large, 80cc (Single) (2 1/4” diameter).
PULPDENT CORPORATION
B-ML
In Commercial Distribution

  • D701BML2 ()


  • Dental material mixing surface, chairside, reusable
Non-stick silicone for acrylics, with suction base. Assorted (Set: 2 Small, 1 Medium, 1 Large)
PULPDENT CORPORATION
B-MA
In Commercial Distribution

  • D701BMA2 ()
  • D701BMA1 ()


  • Dental material mixing surface, chairside, reusable
Bone Cement Mixing System Accessory: Trumpet Adapter[Model No.:CL006-01]
Guangzhou Clean Medical Products Manufacturing Corp.
CL006-01-18(CM194)
In Commercial Distribution

  • 04260102136038 ()
CL006-01-18(CM194)

  • Manual orthopaedic cement mixer, single-use
PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing system PALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum.
Heraeus Medical GmbH
UNO
In Commercial Distribution

  • 04260102133587 ()
  • 04260102133600 ()
  • 04260102133594 ()
66057893

  • Manual orthopaedic cement mixer, single-use
Nozzle to be used in combination with PALACOS Pro system
Heraeus Medical GmbH
66054436
In Commercial Distribution

  • 04260102133037 ()
  • 04260102133051 ()


  • Manual orthopaedic cement mixer, reusable
A slab, tray, or well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic or glass and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a reusable device.
OSUNG MND Co., Ltd.
BWSUS1
In Commercial Distribution

  • 08800075626318 ()


  • Dental material mixing surface, chairside, reusable
No Description
SALVIN DENTAL SPECIALTIES, LLC
GRAFT-DISH
In Commercial Distribution

  • 00841336103498 ()


  • Dental material mixing surface, chairside, reusable
White 2-Cavity Mixing Wells (2-pcs)
PARKELL, INC.
S373
In Commercial Distribution

  • 00810000529650 ()
  • 10810000529657 ()
S373

  • Dental material mixing surface, chairside, reusable
Buck Femoral Cement Restrictor Inserter 14"
Avalign Technologies, Inc.
1-112428
In Commercial Distribution

  • 00190776399221 ()


  • Manual orthopaedic cement mixer, reusable
MIXOR HOSE ADAPTER FOR STRYKER PUMP
Smith & Nephew, Inc.
71270060
In Commercial Distribution

  • 03596010472175 ()
71270060

  • Manual orthopaedic cement mixer, reusable
CEMENT DRILL 4.5MM
Smith & Nephew, Inc.
71369045
In Commercial Distribution

  • 03596010437617 ()
71369045

  • Manual orthopaedic cement mixer, reusable
MIX-OR VACUUM PUMP CONNECTOR - DISS
Smith & Nephew, Inc.
71270052
Not in Commercial Distribution

  • 03596010384645 ()
71270052

  • Manual orthopaedic cement mixer, reusable
MIX-OR VACUUM PUMP CONNECTOR - DRAGER
Smith & Nephew, Inc.
71270051
Not in Commercial Distribution

  • 03596010384638 ()
71270051

  • Manual orthopaedic cement mixer, reusable
MIXOR PUMP ONLY
Smith & Nephew, Inc.
71270042
In Commercial Distribution

  • 03596010384607 ()
71270042

  • Manual orthopaedic cement mixer, reusable
MIXOR HOSE ONLY
Smith & Nephew, Inc.
71270041
In Commercial Distribution

  • 03596010384591 ()
71270041

  • Manual orthopaedic cement mixer, reusable
BUCK FEMORAL CEMENT RESTRICTOR INSERTER
Smith & Nephew, Inc.
112428
In Commercial Distribution

  • 03596010041968 ()
112428

  • Manual orthopaedic cement mixer, reusable
PLASTIC CEMENT SPATULA
Smith & Nephew, Inc.
111802
Not in Commercial Distribution

  • 03596010040077 ()
111802

  • Manual orthopaedic cement mixer, reusable
FEMORAL CEMENT COMPRESSOR
Smith & Nephew, Inc.
111434
In Commercial Distribution

  • 03596010038890 ()
111434

  • Manual orthopaedic cement mixer, reusable
ACETABULAR CEMENT COMPRESSOR
Smith & Nephew, Inc.
111430
In Commercial Distribution

  • 03596010038852 ()
111430

  • Manual orthopaedic cement mixer, reusable
BUCK CEMENT RESTRICTOR VENT OPENING TOOL
Smith & Nephew, Inc.
110028
In Commercial Distribution

  • 03596010033246 ()
110028

  • Manual orthopaedic cement mixer, reusable
MixStar eMotion. Fully automatic mixing device for impression materials. High-Speed Design.
DMG Chemisch-Pharmazeutische Fabrik GmbH
999482
In Commercial Distribution

  • EDMG9994821 ()
999482

  • Dental impression material mixer
DYNAMIC MIXING TIPS YELLOW
DARBY DENTAL SUPPLY, LLC
5251881
In Commercial Distribution

  • 00889813051061 ()
  • 00889813051382 ()
5251881

  • Dental impression material mixer
TMIX CORE XFINE IO TIP BROWN
DARBY DENTAL SUPPLY, LLC
5251879
In Commercial Distribution

  • 00889813051047 ()
  • 00889813051368 ()
5251879

  • Dental impression material mixer
TMIX PERM CEMENT BLACK TIP
DARBY DENTAL SUPPLY, LLC
5251877
In Commercial Distribution

  • 00889813051023 ()
  • 00889813051344 ()
5251877

  • Manual orthopaedic cement mixer, single-use
INTRAORAL CLEAR RIBBON TIPS
DARBY DENTAL SUPPLY, LLC
5251871
In Commercial Distribution

  • 00889813050965 ()
  • 00889813051283 ()
5251871

  • Dental impression material mixer
TMIX C&B TIP 1:1 BLUE/WHITE
DARBY DENTAL SUPPLY, LLC
5251887
In Commercial Distribution

  • 00889813051122 ()
  • 00889813051443 ()
5251887

  • Dental impression material mixer
TMIX C&B TIP 10:1/4:1 BLU/ORG
DARBY DENTAL SUPPLY, LLC
5251886
In Commercial Distribution

  • 00889813051115 ()
  • 00889813051436 ()
5251886

  • Dental impression material mixer
DYNAMIC MIXING TIPS BLUE
DARBY DENTAL SUPPLY, LLC
5251882
In Commercial Distribution

  • 00889813051078 ()
  • 00889813051399 ()
5251882

  • Dental impression material mixer
TMIX CORE IO TIP BROWN
DARBY DENTAL SUPPLY, LLC
5251880
In Commercial Distribution

  • 00889813051054 ()
  • 00889813051375 ()
5251880

  • Dental impression material mixer
No Description
IMEDICOM CO., LTD.
MCX-BI
In Commercial Distribution

  • 08800038031999 ()


  • Manual orthopaedic cement mixer, single-use
I Disposable Mixing Bowl and Spatula
STRYKER CORPORATION
6201003410
In Commercial Distribution

  • 34546540257803 ()
  • 04546540257802 ()
6201003410

  • Manual orthopaedic cement mixer, reusable
Dental impression material mixer, type 2
Renfert GmbH
61001000
In Commercial Distribution

  • J009610010000 ()
61001000

  • Dental impression material mixer
Dental impression material mixer, type 1
Renfert GmbH
60001000
In Commercial Distribution

  • J009600010000 ()
60001000

  • Dental impression material mixer
Dental impression material mixer, Brand Dentsply-Sirona
Renfert GmbH
2761001000
In Commercial Distribution

  • J00927610010000 ()
2761001000

  • Dental impression material mixer
Dental impression material mixer, Brand Kulzer GmbH
Renfert GmbH
2562001000
In Commercial Distribution

  • J00925620010000 ()
2562001000

  • Dental impression material mixer
MIXER A07A CEMENT
MEDTRONIC SOFAMOR DANEK, INC.
A07A
In Commercial Distribution

  • 00643169097889 ()


  • Manual orthopaedic cement mixer, reusable
MIXING BOWLS
Premium Plus International Limited
7470-Y
In Commercial Distribution

  • D8387470Y8 ()
  • D8387470Y6 ()
  • D8387470Y4 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
7470-R
In Commercial Distribution

  • D8387470R8 ()
  • D8387470R6 ()
  • D8387470R4 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
7470-L
In Commercial Distribution

  • D8387470L8 ()
  • D8387470L6 ()
  • D8387470L4 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
7470-G
In Commercial Distribution

  • D8387470G8 ()
  • D8387470G6 ()
  • D8387470G4 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
7470-B
In Commercial Distribution

  • D8387470B8 ()
  • D8387470B6 ()
  • D8387470B4 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
7460-Y
In Commercial Distribution

  • D8387460Y8 ()
  • D8387460Y6 ()
  • D8387460Y4 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
7460-R
In Commercial Distribution

  • D8387460R8 ()
  • D8387460R6 ()
  • D8387460R4 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
7460-L
In Commercial Distribution

  • D8387460L8 ()
  • D8387460L6 ()
  • D8387460L4 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
7460-G
In Commercial Distribution

  • D8387460G8 ()
  • D8387460G6 ()
  • D8387460G4 ()


  • Dental material mixing surface, chairside, reusable
MIXING BOWLS
Premium Plus International Limited
7460-B
In Commercial Distribution

  • D8387460B8 ()
  • D8387460B6 ()
  • D8387460B4 ()


  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Small, 150cc, Dark Green
PLASDENT CORPORATION
904MB-S
In Commercial Distribution

  • D832904MBS0 ()
904MB-S

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Medium, 350cc, Pink
PLASDENT CORPORATION
904MBM-6C
In Commercial Distribution

  • D832904MBM6C0 ()
904MBM-6C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Medium, 350cc, Red
PLASDENT CORPORATION
904MBM-5C
In Commercial Distribution

  • D832904MBM5C0 ()
904MBM-5C

  • Dental material mixing surface, chairside, reusable
Mixing Bowl, Medium, 350cc, Green
PLASDENT CORPORATION
904MBM-4C
In Commercial Distribution

  • D832904MBM4C0 ()
904MBM-4C

  • Dental material mixing surface, chairside, reusable
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