FDA.report

Smartlite Pro Endo Activator

Primary DI
D0016444311
Brand
Smartlite Pro Endo Activator
Company
Dentsply International Inc.
Model
644431
Catalog number
644431
Published
2022-11-11
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
EKQPREPARER, ROOT CANAL ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKQPreparer, Root Canal EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0016444311PrimaryHIBCC0

GMDN Terms

TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
606173334
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
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
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21
D0013010321Ceramco® 3Powder Opaque Modifier Sienna3010322016-09-21
D0013010361Ceramco® 3Powder Opaque Modifier Pink3010362016-09-21
D0013010371Ceramco® 3Powder Opaque Modifier Ochre3010372016-09-21
D0013010481Ceramco® 3Paste Opaque A3.53010482016-09-21
D0013010591Ceramco® 3Paste Opaque C23010592016-09-21
D0013010701Ceramco® 3Paste Opaque Modifiers White3010702016-09-21
D0013011031Ceramco® 3Opaceous Dentin i13011032016-09-21
D0013011071Ceramco® 3Opaceous Dentin A3.53011072016-09-21
D0013011101Ceramco® 3Opaceous Dentin i63011102016-09-21
D0013011181Ceramco® 3Opaceous Dentin C23011182016-09-21
D0013011221Ceramco® 3Opaceous Dentin D33011222016-09-21
D0013011501Ceramco® 3Dentin C43011502016-09-21
D0013011611Ceramco® 3Dentin Modifier A3.53011612016-09-21
D0013011671Ceramco® 3Dentin Modifier Blue3011672016-09-21
D0013012001Ceramco® 3Natural Enamel White3012002016-09-21
D0013012011Ceramco® 3Natural Enamel Extra Light3012012016-09-21
D0013013221Ceramco® 3Overglaze3013222016-09-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850440008407EDTAEngineered Endodontics, LLCEKQ2026-01-02
TQ26126091140Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091160Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091180Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091200Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091220Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091240Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091260Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091280Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091300Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091320Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091340Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091360Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091380Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091400Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091420Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091440Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091460Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091470Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091480Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091490Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091500Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091510Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091520Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091530Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091540Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091550Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091560Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091570Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091580Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28