FDA.report

Plasdent

Primary DI
D832XR0010
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
XR-001
Catalog number
XR-001
Device description
Film Carrier #1, Black
Published
2022-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EGZHolder, Film, X-Ray

Product Code Classifications

CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D832XR0011PrimaryHIBCC0
D832XR0010Unit of UseHIBCC0

GMDN Terms

TermDefinition
X-ray film cassette holderA device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).

Sterilization Methods

Method

Regulatory Flags

DUNS number
190377184
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D832600BA4000MAXAPPLICATOR II600B-A-400600B-A-4002025-08-01
D832600BF4000MAXAPPLICATOR II600B-F-400600B-F-4002025-08-01
D832600BR4000MAXAPPLICATOR II600B-R-400600B-R-4002025-08-01
D832600BSF4000MAXAPPLICATOR II600B-SF-400600B-SF-4002025-08-01
D83230000EXPANDII FLOSSII300030002025-06-02
D8323000B0EXPANDII FLOSSII3000B3000B2025-06-02
D8323000T0EXPANDII FLOSSII3000T3000T2025-06-02
D83231000FINE FLOSSII310031002025-06-02
D8323100B0FINE FLOSSII3100B3100B2025-06-02
D8323100T0FINE FLOSSII3100T3100T2025-06-02
D832CTRS20000PlasdentCTR-S2000CTR-S20002024-11-12
D832CTRS5400PlasdentCTR-S540CTR-S5402024-11-12
D8329000HVEXT0Plasdent 9000HV-EXT9000HV-EXT2024-09-06
D8329000PLG0Plasdent 9000PLG9000PLG2024-09-06
D832CCIMP20PlasdentCC-IMP2CC-IMP22024-09-06
D832TSTSA0ACUTIPS TST-SATST-SA2024-08-27
D832IITBIENAIR0PlasdentIIT-BIENAIRIIT-BIENAIR2024-07-30
D832IITKAVOT0PlasdentIIT-KAVO-TIIT-KAVO-T2024-07-30
D832IITNSK0PlasdentIIT-NSKIIT-NSK2024-07-30
D832IITU10PlasdentITT-U1ITT-U12024-07-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
E24721301003290VistaPosition AnteriorDÜRR DENTAL SEEGZ2026-03-13
E24721301003300VistaPosition PosteriorDÜRR DENTAL SEEGZ2026-03-13
E24721301003320VistaPosition EndoDÜRR DENTAL SEEGZ2026-03-13
E24721301003330VistaPosition BitewingDÜRR DENTAL SEEGZ2026-03-13
00810126506092Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506184Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506818Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506825Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2026-03-05
00810126506801Visionary By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2025-12-16
00817169029335Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2025-12-16
00817169029861Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEGZ2025-12-16
00371347019636Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
08404535005134Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005226Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005257Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005288Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005349Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-11-07
08404535005011Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005042Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005073Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005103Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005165Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005196Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005318Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
08404535005370Brasseler USAPeter Brasseler Holdings, LLCEGZ2025-10-28
07898561549150Cartridge (box) containing one pot with Digital Sensor Cone PositionerMaquira Industria de Produtos Odontologicos S/AEGZ2025-09-05
00304040192115CarinaHENRY SCHEIN, INC.EGZ2025-05-13
00304040190630Henry ScheinHENRY SCHEIN, INC.EGZ2025-03-05
D00361765100XiosDentsply International Inc.EGZ2024-11-06
D00361765280XiosDentsply International Inc.EGZ2024-11-06