FDA.reportPublic FDA data

Phosphor Storage Plate

Primary DI
D6787344540
Brand
Phosphor Storage Plate
Company
AIR TECHNIQUES, INC.
Model
73445-4
Device description
The reusable phosphor storage plates are used to store intraoral or extraoral X-ray images in dental applications. Intraoral phosphor storage plates must be used in combination with Air Techniques barrier envelopes.
Published
2022-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWZFilm, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWZFilm, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6787344541PackageHIBCC1In Commercial Distribution
D6787344540PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging cassette/storage phosphor screen, dentalA combination device for dental applications that consists of a cassette (barrier envelope) used to hold and shield an attached phosphor storage screen [mounted on a phosphor storage plate (PSP)] from exposure to room light during transport and insertion into a diagnostic dental x-ray system, and a computed radiography scanner. The photostimulatable phosphor storage screen is exposed to radiation by the dental x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1 (516) 214-5512mardonio.nicolas@airtechniques.com

Regulatory Flags#

DUNS number
043835081
Device count
1
Premarket exempt
true
Lot or batch
true

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Primary DI, Brand, Model table
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D678J12050ScanX Duo TouchJ1205J12002023-04-21
D678732482K1ScanX Barrier Envelopes73248-2K2023-09-12
D6787324801ScanX Barrier Envelopes73248-02019-08-23
D678A63410"Provecta HD 16"" Center to Center Wall Mounting Plate"A63412023-07-11
D678A63890Provecta HD Single Post Mounting PlateA63892023-07-11
D678A63301Provecta HD 16" Center to Center Wall Mounting PlateA63412023-07-11
D678A63361Provecta HD Single Post Mounting PlateA63892023-07-11
D678AS1200AirStar Clinical Air CompressorAS1202023-06-14
D678AS120C0AirStar Clinical Air CompressorAS120C2023-06-14
D678AS600AirStar Clinical Air CompressorAS602023-06-14

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Primary DI, Brand, Company table
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