FDA.report

TrollByte

Primary DI
17310230020144
Brand
TrollByte
Company
Directa AB
Model
Kimera Kit 3803/2905
Catalog number
1570382905
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
17310230020144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1731023002014417310230020144

GMDN Terms

TermDefinition
Dental x-ray film holder, reusableA device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
353954381
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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17310230021592LuxatorP2506632U2022-12-07
17310230021608LuxatorP3506633U2022-12-07
17310230021615LuxatorP4506634U2022-12-07
17310230021493LuxatorL2S TiN506434U2022-12-07

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