FDA.reportPublic FDA data

Planmeca Sovereign

Primary DI
06430035420100
Brand
Planmeca Sovereign
Company
Planmeca Oy
Model
Classic
Catalog number
10032746, 10032747
Device description
Planmeca Sovereign is a dental operative unit including a dental patient chair. The versatile swivelling enables fluent two-handed and four-handed treatment sequences as well as both left-handed and right-handed use. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease of use.The instrument console includes six instrument locations, with easy instrument interchange.
Published
2017-05-05
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
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081699000PLANMECA SOVEREIGNPlanmeca USA, Inc.2008-08-29EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035420100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035420100064300354201006430035420100

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery systemA stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

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
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
06430035420162Planmeca ChairChair100260002017-05-08
06430035420407Planmeca ProMaxProMax 3D Plus300169442016-08-10

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Primary DI, Brand, Company table
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J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
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