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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E27662291290SIDEXIS XG62291292016-09-10
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E27666164650Sidexis 466164652017-04-20
E27666632770Sidexis 466632772018-08-27
E27668234260Primevision 3D682342667585982026-02-13
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E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27660437020IMPLANT 20:160437022016-09-10
E27668082030Primescan 268082032025-11-21
E27668325910TiBase683259168325912025-10-28
E27668326410TiBase683264168326412025-10-28

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