FDA.reportPublic FDA data

Dalbo®-PLUS

Primary DI
07640166511403
Brand
Dalbo®-PLUS
Company
Cendres+Métaux SA
Model
05001240
Catalog number
05001240
Device description
Dalbo®-PLUS Female Part Basic
Published
2020-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJXAnchor, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJXAnchor, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640166511403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166511403076401665114037640166511403

GMDN Terms#

Term, Definition table
TermDefinition
Root canal post, preformedA prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCEJX2026-07-13
08059224208152OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-06-23
08059224208183TITANIUM EASY FIX T-BASE h9RHEIN 83 SRLEJX2026-06-23
07640239932098Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
07640239932104Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
08059224207810OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224208169OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224001661OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224108865OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224136905OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165189OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165196OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165202OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224166117OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168135OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168173OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168180OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224169910OT EQUATORRHEIN 83 SRLEJX2025-07-07
D990CTB1PK0Cementable TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PK0Pre-Coated TiBase 10PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKEX0Pre-Coated TiBase 10PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKIT0Pre-Coated TiBase 10PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKOA0Pre-Coated TiBase 10PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PK0Pre-Coated TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKEX0Pre-Coated TiBase 1PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKIT0Pre-Coated TiBase 1PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKOA0Pre-Coated TiBase 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKOA0Recharge Kit w/ Tall Spare Parts, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKPOCOA0Recharge Kit w/ POC, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990SFA10PKDKOA0Separable Fastener Assembly 10PK - Drill Kit Included, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19