FDA.reportPublic FDA data

Panoramic Corporation

Primary DI
00862309000330
Brand
Panoramic Corporation
Company
YOUNG PS ACQUISITION, LLC
Model
PC-3000
Device description
Unit, X-ray, Extraoral with Timer- PC-3000
Published
2017-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043557000MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMSPanoramic Corp.2005-01-13EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862309000330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862309000330008623090003308623090003300862309000330

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119620784
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862309000309Panoramic CorporationPC-10002017-05-24
00862309000316Panoramic CorporationPC-1000/Laser 10002017-05-24
00862309000347Panoramic CorporationPC-40002017-05-24
00862309000354Panoramic CorporationDigital Pnaormic X-Ray Encompass2017-05-24
00862309000361Panoramic CorporationCCD Encompass2017-05-24
00862309000378Panoramic Corporation3D Encompass2017-05-24
00862309000385Panoramic Corporation - Envision P97682040132018-04-20
00862309000392Panoramic Corporation - Envision C197682040142018-04-20

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Primary DI, Brand, Company table
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D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
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07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
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