FDA.reportPublic FDA data

EasyTip Endo Pack 25

Primary DI
E27665358890
Brand
EasyTip Endo Pack 25
Company
SIRONA Dental Systems GmbH
Model
6535905
Device description
Endo Tips for SIROLaser Blue
Published
2020-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
E27665359052PrimaryHIBCC0
E27665358890Unit 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
340306351
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27665716860SiroLaser65716862025-09-03
E27662122080Motor BL implant62122082025-08-20
E27668534800CAD/CAM Software68534802025-08-19
E2766802040Primescan 2680204068020402025-05-16
E27668020400Primescan 2680204068020402025-05-16
E27668053650Primescan 2 Multiuse Sleeve680536568053652025-05-06
E27668325750TiBase683257568325752025-05-06
E27668325830TiBase683258368325832025-05-06
E27668326090TiBase683260968326092025-05-06
E27668326170TiBase683261768326172025-05-06
E27668326250TiBase683262568326252025-05-06
E27668326330TiBase683263368326332025-05-06
E27668326580TiBase683265868326582025-05-06
E27668326660TiBase683266668326662025-05-06
E27668004570Primescan 2 Cart680045768004572025-03-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08052286590517LASER THERMAL THERAPY KIT L EELESTA SPAGEX2026-03-24
06975617991024DIODE LASER FOR HIAR REMOVALBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617992014Q-SWITCHED ND:YAG LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617993011CO2 FRACTIONAL LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
16977331780080GigaaMedGigaalaser Company Ltd.GEX2026-03-19
02816901023318NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
02816901024032NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
01816901024156NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
00860015460615NextGen Aesthetics CO2T AESTHETICS LLCGEX2026-03-12
00860015460639NextGen Aesthetics LHRT AESTHETICS LLCGEX2026-03-12
08034108512877TORODEKA M.E.L.A. SRLGEX2026-03-11
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