FDA.reportPublic FDA data

Planmeca Onyx

Primary DI
06430035421077
Brand
Planmeca Onyx
Company
Planmeca Oy
Model
1
Catalog number
30067207
Device description
The Planmeca Onyx optical impression system is used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition, it can record the topographical characteristics of the oral anatomy.
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035421077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035421077064300354210776430035421077

GMDN Terms#

Term, Definition table
TermDefinition
Dental milling system, CAD/CAM, chairsideAn assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.

Regulatory Flags#

DUNS number
368788568
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06430035420162Planmeca ChairChair100260002017-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970163089140SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-20
06975456126007UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.NOF2026-05-18
06970163084022SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084039SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084046SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
08800026700760Medit Link ExpressMedit Corp.NOF2026-04-28
08800026700883Medit Link ExpressMedit Corp.NOF2026-04-28
06973993442499Intraoral ScannerAlliedstar Medical Equipment Co., Ltd.NOF2026-04-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCNOF2026-04-13
06970163089966SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089973SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089836SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-16
D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
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07540209957642MicronMapperClaronav IncNOF2026-02-10