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MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
MC-KP110
Not in Commercial Distribution
- 00810007631523 ()
MC-KP110
- Custom-made organ/bone anatomy model/surgical guide kit
- Dental milling system, CAD/CAM, laboratory
- Craniofacial fixation plate, non-bioabsorbable, non-customized
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
MC-KP100
Not in Commercial Distribution
- 00810007631516 ()
MC-KP100
- Custom-made organ/bone anatomy model/surgical guide kit
- Dental milling system, CAD/CAM, laboratory
- Craniofacial fixation plate, non-bioabsorbable, non-customized
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
ZB-KP200
Not in Commercial Distribution
- 00810007631318 ()
ZB-KP200
- Custom-made organ/bone anatomy model/surgical guide kit
- Dental milling system, CAD/CAM, laboratory
- Craniofacial fixation plate, non-bioabsorbable, non-customized
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
ZB-KP210
Not in Commercial Distribution
- 00810007631301 ()
ZB-KP210
- Custom-made organ/bone anatomy model/surgical guide kit
- Dental milling system, CAD/CAM, laboratory
- Craniofacial fixation plate, non-bioabsorbable, non-customized
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
ZB-KP110
Not in Commercial Distribution
- 00810007631172 ()
ZB-KP110
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Dental milling system, CAD/CAM, laboratory
- Custom-made organ/bone anatomy model/surgical guide kit
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
ZB-KP100
Not in Commercial Distribution
- 00810007631165 ()
ZB-KP100
- Custom-made organ/bone anatomy model/surgical guide kit
- Dental milling system, CAD/CAM, laboratory
- Craniofacial fixation plate, non-bioabsorbable, non-customized
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV
+ Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution
- 00810035220508 ()
- Indirect flat panel x-ray detector
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV
+ Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919.
We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution
- 00810035220515 ()
- Indirect flat panel x-ray detector
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV
+ Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution
- 00810035220492 ()
- Indirect flat panel x-ray detector
This is a 3D face scanner that works with the supplied software programs. By performing facial scanning directly, the scanner could acquire and save the 3D images of the face and the jaw movement tracking data, which can be used for the facial or the oral Computer-aided design (CAD).
Shining 3D Tech Co., Ltd.
MetiSmile
In Commercial Distribution
- 06970163088013 ()
- Jaw physiology evaluation system