FDA.reportPublic FDA data

AdvErL EVO

Primary DI
04548213020911
Brand
AdvErL EVO
Company
J.MORITA MFG.CORP.
Model
MEY-1-A
Published
2016-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K120377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120377000ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-AJ. Morita USA, Inc.2012-07-25GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548213020911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548213020911045482130209114548213020911

GMDN Terms#

Term, Definition table
TermDefinition
Dental solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
693811465
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04548213056545Root ZX3RZX3 Type: HF2023-06-27
04548213021260Spaceline EMCIACU-5802026-04-15
04548213015641Root ZX miniRCM-72026-04-07
04548213055999J. MORITA MFG. CORP.TR-ZX2 Type PLUS2023-03-06
04548213027408J. MORITA MFG. CORP.CA-5IF2023-02-01
04548213060153STERLINGBEN-4HEX-O-KV-452026-02-20
04548213060160STERLINGBEN-4HG-O-KV2026-02-20
04548213060177STERLINGBEN-4HG-O-NK2026-02-20
04548213057320TWINPOWER TURBINE 4HPAR-4HG-O2026-02-03
04548213057337TWINPOWER TURBINE 4HPAR-4HG-O-KV2026-02-03
04548213057344TWINPOWER TURBINE 4HPAR-4HG-O-NK2026-02-03
04548213057368TWINPOWER TURBINE 4HPAR-4HG-O-WH2026-02-03
04548213057375TWINPOWER TURBINE 4HPAR-4HG-O-SR2026-02-03
04548213745043Midwest 45 FBE NFO7450442023-08-18
04548213745241Midwest 45 K-Style NFO7452442023-08-18
04548213016556TORQTECHCA-5IF-O2022-12-19
00887919758013EndoSync A.I.RCM-75025412U02022-12-12
00887919832249EndoSync PLUSTR-CM5027135U02022-12-12
04548213008476N/ACP42022-12-12

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Primary DI, Brand, Company table
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08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
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08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
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08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
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