FDA.reportPublic FDA data

Dalbo®-PLUS

Primary DI
07640173095828
Brand
Dalbo®-PLUS
Company
Cendres+Métaux SA
Model
07000389
Catalog number
07000389
Device description
Dalbo®-PLUSScrewdriver / Activator
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640173095828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640173095828076401730958287640173095828

GMDN Terms#

Term, Definition table
TermDefinition
Dental precision attachment fitting/adjustment toolA manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41583602000info@cmsa.ch

Regulatory Flags#

DUNS number
487506230
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640239932098Dalbo®-PLUS05000081050000812026-02-16
07640239932104Dalbo®-PLUS05000083050000832026-02-16
07640239932562Dalbo®-Classic05003693050036932026-02-16
07640239932579Dalbo®-Classic05003695050036952026-02-16
97640173081831Dentalor 6001000302010003022024-07-01
97640173081848Dentalor 6001000303010003032024-07-01
97640173081855Dentalor 6001000304010003042024-07-01
97640173081862Dentalor 6001000305010003052024-07-01
97640173082036Solaro 401000322010003222024-07-01
97640173082043Solaro 401000323010003232024-07-01
97640173082050Solaro 401000324010003242024-07-01
07640239932135Soprano® 1008058742080587422024-06-04
07640239932142Soprano® 1008058743080587432024-06-04
07640239932159Soprano® 1008058744080587442024-06-04
07640239932166Soprano® 1008058745080587452024-06-04
07640239932173Soprano® 1008058746080587462024-06-04
07640239932180Soprano® 1008058747080587472024-06-04
07640239932197Soprano® 1008058748080587482024-06-04
07640239932203Soprano® 1008058749080587492024-06-04
07640239932210Soprano® 1008058750080587502024-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E0HM36KHKS1Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungNDP2026-10-23
07392532032349Bone TrapDentsply Implants Manufacturing GmbHNDP2026-10-16
06009544052913N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-14
08809918259713LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07