FDA.reportPublic FDA data

Planmeca Chair

Primary DI
06430035420162
Brand
Planmeca Chair
Company
Planmeca Oy
Model
Chair
Catalog number
10026000
Device description
Planmeca Chair is electronically controlled patient chair with swivel funcion allowing the chair to be swivelled 90 degrees to left and right. The chair has an integrated foot control for automatic chair positions and manual movements. The chair can be equipped with optional foldable knee-break.
Published
2017-05-08
Public version status
Update
Distribution status
Not 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
K923534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923534000PM2002 PROLINEPlanmeca USA, Inc.1994-01-31KLC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035420162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035420162064300354201626430035420162

GMDN Terms#

Term, Definition table
TermDefinition
Dental chair, electricA mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
368788568
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035420292Planmeca ProMaxProMax 2D100306882016-08-10
06430035420988Planmeca VisoG5 (G3)30048120, 30035196, 30016794, 30054720, 30064043, 2024-01-10
06430035420322Planmeca ProOneProOne30010469, 30054727, 300547352016-08-10
06430035420360Planmeca IntraProX10029551, 30054728, 30054748, 30054749, 30054750, 2016-08-10
06430035420445Planmeca ProMaxProMax 2D30003108, 30054723, 30064278, 30054724, 30054736, 2016-09-19
06430035420452Planmeca ProMaxProMax 2D30003107, 30054725, 30064279, 30054726, 30054738, 2016-09-19
06430035420476Planmeca ProMaxProMax 3D30003109, 30054721, 30064042, 30054722, 30054744, 2016-09-19
06430035420995Planmeca VisoG730048121,30016793, 300642692024-01-10
06430035420483Planmeca ProMaxProMax 3D Plus30016946, 30054717, 30054719, 30064041, 30054740, 2016-09-19
06430035420490Planmeca ProMaxProMax 3D Mid30003112, 30054742, 300547432016-09-19
06430035420551Planmeca VisoG730004941,30064509, 300547322018-09-21
06430035420100Planmeca SovereignClassic10032746, 100327472017-05-05
06430035420346Planmeca ProMaxProMax 3D300169432016-08-10
06430035420353Planmeca ProMaxProMax 3D Max100200192016-08-10
06430035420469Planmeca ProMaxProMax 3D300169452016-09-19
06430035420506Planmeca ProMaxProMax 3D Max300031142016-09-19
06430035420513Planmeca ProMaxProMax 3D Max300031152016-09-19
06430035420599Planmeca Romexis6100415462023-06-14
06430035420964Planmeca Pro50 Chair-2022-12-19
06430035420407Planmeca ProMaxProMax 3D Plus300169442016-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-09-04
07899581340925Dental ChairAlliage S/A Indústrias Médico OdontológicaKLC2025-07-25
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
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