FDA.reportPublic FDA data

Dalbo®-Z

Primary DI
07640166513988
Brand
Dalbo®-Z
Company
Cendres+Métaux SA
Model
051507
Catalog number
051507
Device description
Dalbo®-Z Female part O
Published
2020-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
07640166513988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166513988076401665139887640166513988

GMDN Terms#

Term, Definition table
TermDefinition
Dental anchorA device made of austenitic alloys or alloys containing 75 percent or greater gold (Au) or metals of the platinum group, intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
487506230
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
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
D990PTB10PKOA0Pre-Coated TiBase 10PK, OmnibutSmart Denture Conversions, LLCEJX2025-05-19
D990STB1PK0Standard TiBase 1PKSmart Denture Conversions, LLCEJX2025-05-19
D990STB1PKOA0Standard TiBase 1PK, OmnibutSmart Denture Conversions, LLCEJX2025-05-19
D990TC10PKOA0Temporary Cylinder 10PK, OmnibutSmart Denture Conversions, LLCEJX2025-05-19
D990TC1PKOA0Temporary Cylinder 1PK, OmnibutSmart Denture Conversions, LLCEJX2025-05-19
D990TTB1PK0Tall TiBase 1PKSmart Denture Conversions, LLCEJX2025-05-19
D990TTB1PKOA0Tall TiBase 1PK, OmnibutSmart Denture Conversions, LLCEJX2025-05-19
08059224205366OT EQUATORRHEIN 83 SRLEJX2025-04-30
08059224205373OT EQUATORRHEIN 83 SRLEJX2025-04-30
08059224205380OT EQUATORRHEIN 83 SRLEJX2025-04-30
08059224205397OT EQUATORRHEIN 83 SRLEJX2025-04-30
08059224205403OT EQUATORRHEIN 83 SRLEJX2025-04-30
08059224205410OT EQUATORRHEIN 83 SRLEJX2025-04-30