FDA.reportPublic FDA data

EasyTip Endo Pack 25

Primary DI
E27666592832
Brand
EasyTip Endo Pack 25
Company
SIRONA Dental Systems GmbH
Model
6659283
Device description
Endo Tips for SIROLaser Advance Plus, 25 pcs. Sculpt IQ
Published
2020-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27666592832PrimaryHIBCC0
E27666599600Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.

Contacts#

Phone, Email table
PhoneEmail
+496251161670contact@dentsplysirona.com

Regulatory Flags#

DUNS number
340306351
Device count
25
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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E27668325910TiBase683259168325912025-10-28
E27668326410TiBase683264168326412025-10-28
E27668082450Primescan 2680824568082452025-10-23
E27668534800CAD/CAM Software68534802025-08-19
E27660471250Motor BL 60471252016-09-10
E27663375180Motor BL ISO C63375182016-09-10
E27663082950TiBase63 08 29563 08 2952015-10-17
E27668665240Midwest68665242025-10-17
E27668053651Primescan 2 Multiuse Sleeve680536568053652025-09-16
E27668558402Primescan 2685584068558402025-08-20
E27668020400Primescan 2680204068020402025-05-16
E27665716860SiroLaser65716862025-09-03

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08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
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