FDA.report

Smartlite Pro Endo Activator

Primary DI
D0016444321
Brand
Smartlite Pro Endo Activator
Company
Dentsply International Inc.
Model
644432
Catalog number
644432
Published
2022-11-10
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
D0016444321PrimaryHIBCC0

GMDN Terms

TermDefinition
Solution agitatorA mains electricity (AC-powered), electromechanical, device typically used to keep substances, e.g., a liquid, liquids, or a combination of particles suspended in these, in a continual motion in order to prevent sedimentation. This device can achieve this by mechanical movement, by ultrasonic means, or other techniques. For devices used during the tapping of blood from blood donors and devices that mix components in the laboratory see the respective GMDN code.

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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850440008407EDTAEngineered Endodontics, LLCEKQ2026-01-02
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