FDA.reportPublic FDA data

N/A

Primary DI
08809447651521
Brand
N/A
Company
Lutronic Corporation
Model
DENTA II arm
Device description
DENTA II Articulated Arm(DENTA II arm)
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091320000SPECTRA SP II, SPECTRA DENTA IILutronic Corporation2009-08-19GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
8809447651538PackageGS11In Commercial Distribution
08809447651521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
8809447651538088094476515388809447651538
08809447651521088094476515218809447651521

GMDN Terms#

Term, Definition table
TermDefinition
Dental carbon dioxide laser systemA mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite carbon dioxide (active medium) to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation for application in dental procedures, mainly to excise or vaporize tissue in the oral cavity. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It typically emits energy at a wavelength of 10,600 nm (far infrared) to tissues through a handpiece; it may be operated in continuous-wave or pulsed modes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
215-205-2219jvojir@lutronic.com

Regulatory Flags#

DUNS number
688282516
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809447650883INFINIINFINI MFR G U110V2016-09-09
08809447650982N/AMFR Handpiece 2016-09-09
08809447651019N/AHandpiece cradle2016-09-09
08809447651675N/A830&590nm Head2016-09-09
08809447651699Healite IIHealite Body Assy2016-09-09
08809447651729N/AArm2016-09-09
08809447651781N/ATIP A-49 1 ea2016-11-18
08809447652375INFINI49 pin Tip (Standard) 1 ea2019-01-15
08809447652399INFINI16 pin Tip (Optional) 1 ea2019-01-15
08809447651033N/AMFR 49 TIP II 1 ea2016-09-09
08809447651064N/ATIP A-16 1 ea2016-09-09
08809447651170N/AINFINI Operator's Manual USA2016-09-09
08809447651712N/AManual2016-09-09
08809447652122N/AGoggle ASSY (For patient)2018-08-06
08809447652139N/APatient Goggle2018-08-06
08809447652351INFINI49 pin (Enhanced) 1 ea2019-01-15
08809447657424MOSAIC 3DPill Tip Package2025-11-28
08809447657745XERFXERF EFFECTOR 60(600)2025-11-28
08809447657011MOSAIC 3DMOSAIC 3D2025-11-28
08809447657370MOSAIC 3DSapphire Tip Package2025-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800291820040CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820057CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820187CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820460HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820477HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820484HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
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08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
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08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
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