FDA.reportPublic FDA data

Dental Chair

Primary DI
07899581340925
Brand
Dental Chair
Company
Alliage S/A Indústrias Médico Odontológica
Model
Syncrus G2
Catalog number
41000008156
Device description
CADEIRA SYNCRUS G2 P1
Published
2025-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KLCChair, Dental, With Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLCChair, Dental, With Operative UnitDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863016000DENTATUS L SETSds Dental, Inc.1986-10-01KLC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899581340925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899581340925078995813409257899581340925

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-12 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898231451
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899581345197Intraoral ScannerAXR-S160000047592026-08-22
07899581360671Intraoral ScannerAXR-S160000047922026-08-22
07899581361289Evolve PortableAXR60 S160000047972026-08-22
07899581339639Dental CT Scanner AXRAXR90160000040582023-10-18
07899581342707Delivery UnitSyncrus G2410000082932025-12-31
07899581342844Delivery UnitSyncrus G3410000083072025-12-31
07899581343186Delivery UnitSyncrus G3 H410000083092025-12-31
07899581343414Delivery UnitSyncrus G8 FE410000083492025-12-31
07899581343599Delivery UnitSyncrus G8 HE410000083502025-12-31
07899581343834Water UnitSyncrus G2410000081882025-12-31
07899581343933Water UnitSyncrus G2410000081842025-08-01
07899581343957Water UnitSyncrus G3410000081992025-08-01
07899581344015Water UnitSyncrus G4A410000082052025-08-01
07899581337437EAGLE X-RAYAXR60 S160000034952024-02-26
07899581340703EAGLE X-RAYAXR65 S160000043752024-02-26
07899581340642Dental CT Scanner AXRAXR120160000042552024-02-23
07899581340659Dental CT Scanner AXRAXR120160000042562024-02-23
07899581340734SXR / SaevoAXR90 B160000043702024-02-23
07899581340741SXR / SaevoAXR120 B160000043712024-02-23
07899581340758SXR / SaevoAXR90 B160000043772024-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975220031162Dental UnitLakong Medical Devices Co., Ltd.KLC2026-10-20
06975220031179Dental UnitLakong Medical Devices Co., Ltd.KLC2026-10-20
00810021435916DCI EdgeDCI International, LLCKLC2026-07-21
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-09-04
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-04-24
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDKLC2024-09-19
H816MBB0312H1ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB0528X1ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB2930C1ProBarrierMicroCare, LLCKLC2022-10-26
H816MDC0115S1ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB0312H2ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB0528X2ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB2930C2ProBarrierMicroCare, LLCKLC2022-10-26
H816MDC0115S2ProBarrierMicroCare, LLCKLC2022-10-26
ERICV00000110VanguardRitter Concept GmbHKLC2022-08-17
ERICVP0000110VanguardRitter Concept GmbHKLC2022-08-17
ERICVS0000110VanguardRitter Concept GmbHKLC2022-08-17
ERICVSP000110VanguardRitter Concept GmbHKLC2022-08-17
06430035420162Planmeca ChairPlanmeca OyKLC2017-05-08
H816BB0312H1BarrierCERTOL INTERNATIONAL, LLCKLC2017-01-13
H816BB0312H2BarrierCERTOL INTERNATIONAL, LLCKLC2017-01-13
H816BB0528X1BARRIERCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816BB2930C1BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816DC0115S1BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816BB0528X2BARRIERCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816BB2930C2BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816DC0115S2BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23