FDA.reportPublic FDA data

Visionary by 3D Dental

Primary DI
00817169023333
Brand
Visionary by 3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
XTC-BL
Catalog number
XTC-BL
Device description
Lead Apron Thyroid Collar Blue
Published
2023-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWOApron, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWOApron, ProtectiveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817169023333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817169023333008171690233338171690233330817169023333

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.

Regulatory Flags#

DUNS number
080194935
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126508362Essentials By 3D DentalGN300-L2026-04-16
008101265062213D DentalRCPC2026-03-24
00810126506757Comfortox5CC30132026-03-24
00810126506764Comfortox5CC2982026-03-24
00810126508355Basik by 3D DentalBPGLA4672026-03-17
00810126508331Basik by 3D DentalBPGC9422026-03-17
00810126508348Basik by 3D DentalBPGC9432026-03-17
10817169023019Basik by 3D DentalBPGLA4672026-03-17
008171690214833D Dental - DreamDFVMLDFVML2023-01-11
00817169023005Basik by 3D DentalBPGLA4532026-03-17
00810126506054The Essentials By 3D DentalPL-HCSPL-HCS2023-02-28
00810126506061The Essentials By 3D DentalPL-HRLGPL-HRLG2023-02-28
008171690201723D Dental - DreamDFVBG2016-12-12
008171690201893D Dental - DreamDFVSM2016-12-12
008171690214763D Dental-DreamDFVCM2017-12-04
008171690219643D Dental- BiovivaBHG2018-08-30
008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031VBO2XFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13