FDA.reportPublic FDA data

CM LOC®

Primary DI
07640166511724
Brand
CM LOC®
Company
Cendres+Métaux SA
Model
05001325
Catalog number
05001325
Device description
05001325 CM LOC® Basic Set Pekkton®
Published
2018-06-20
Public version status
Update
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJXAnchor, PreformedDental1
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130618000SFI-ANCHORCendres & Metaux SA2014-03-03NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640166511724PrimaryGS10
07640166511212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166511724076401665117247640166511724
07640166511212076401665112127640166511212

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
07899878066989NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878066996NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067009NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067016NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067023NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067030NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067047NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067054NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067061NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
08800292991923Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991930Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991947Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991954Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991961Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992098Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992104Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992111Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992128Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992135Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992203AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992210AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992227AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992234AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992241AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992258AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992265Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992272Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992289AXZAOAS2006Megagen Implant Co. LtdNHA2026-07-03
08800292992296Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992302Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03