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CEREC® Essentials with Celtra® Chairside Consumables Kit
DENTSPLY INTERNATIONAL INC.
61N002
Not in Commercial Distribution
- D00261N0021 ()
- 12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit
61N002
- Dental appliance fabrication material, ceramic
Pressure PreventionGroup 1 Surfaces Product Description: Enf.,Dlx APP w/Pad w/End Flaps,1/ea, RTL
Drive Devilbiss Healthcare
E-14001EFD
In Commercial Distribution
- 50822383524530 ()
- 00822383524535 ()
- Alternating-pressure bed mattress overlay system
- Alternating-pressure inflator
- Alternating-pressure bed mattress overlay, reusable
Pressure PreventionGroup 1 Surfaces Product Description: Dlx APP w/Pad w/End Flaps,1/CV, 6/CT
Drive Devilbiss Healthcare
14001EFD
In Commercial Distribution
- 00822383145457 ()
- 50822383145452 ()
- Alternating-pressure bed mattress overlay, reusable
- Alternating-pressure inflator
- Alternating-pressure bed mattress overlay system
A clinical information and medical device data system for patient engagement and monitoring of treatment outcomes that can be customised by healthcare professionals to match their treatment pathways. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.
FUTURE HEALTH WORKS LTD
MD
In Commercial Distribution
- G333OUG001 ()
- Configurable electronic form web-based application software
A clinical information system with a digital goniometer. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.
FUTURE HEALTH WORKS LTD
MD
In Commercial Distribution
- G333KQX001 ()
- Electronic goniometer/kinesiology sensor
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets.
This is a 1.1 gm push syringe of Rely A Bond Paste.
RELIANCE ORTHODONTIC PRODUCTS INC
1.1GRPP
In Commercial Distribution
- D79811GRPP0 ()
1.1GRPP
- Orthodontic bracket adhesive
Opti-Free Pure Moist Multi-Purpose Disinfecting Solution Twin Pack 2 x 10 ozhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Alcon Laboratories, Inc.
OPTI-FREE PUREMOIST 2x10oz
In Commercial Distribution
- 00300650361057 ()
- 20300650362539 ()
- 20300650370077 ()
- Multi-purpose soft contact lens solution
Intense Pulsed Light handpiece 625 nm 25x13 (for Discohttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#very Pico family)
QUANTA SYSTEM SPA
OAM002020
In Commercial Distribution
- 08059173390168 ()
- Light-energy skin surface treatment system applicator
Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.
OTODYNAMICS LIMITED
NOVA-TABLET
In Commercial Distribution
- 05060396171512 ()
- Otoacoustic emission system, battery-powered
- Evoked-potential audiometer
Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
ENSODATA, INC.
8.0
In Commercial Distribution
- 00864458000452 ()
- Sleep disorder interpretive software, professional-only