FDA.reportPublic FDA data

CM LOC®

Primary DI
07640166511168
Brand
CM LOC®
Company
Cendres+Métaux SA
Model
05001304
Catalog number
05001304
Device description
05001304 CM LOC CAD/CAM Abutment
Published
2018-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
07640166511168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166511168076401665111687640166511168

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], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]; 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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088000968496738plant Implant System8dent Inc.NHA2026-10-16
088000968499498plant Implant System8dent Inc.NHA2026-10-16
088000968499638plant Implant System8dent Inc.NHA2026-10-16
088000968501438plant Implant System8dent Inc.NHA2026-10-16
088000968501508plant Implant System8dent Inc.NHA2026-10-16
088000968501678plant Implant System8dent Inc.NHA2026-10-16
088000968501818plant Implant System8dent Inc.NHA2026-10-16
088000968501988plant Implant System8dent Inc.NHA2026-10-16
088000968513248plant Implant System8dent Inc.NHA2026-10-16
088000968513318plant Implant System8dent Inc.NHA2026-10-16
088000968513488plant Implant System8dent Inc.NHA2026-10-16
088000968513558plant Implant System8dent Inc.NHA2026-10-16
088000968513628plant Implant System8dent Inc.NHA2026-10-16
088000968513798plant Implant System8dent Inc.NHA2026-10-16
088000968513868plant Implant System8dent Inc.NHA2026-10-16
088000968513938plant Implant System8dent Inc.NHA2026-10-16
088000968514308plant Implant System8dent Inc.NHA2026-10-16
088000968514478plant Implant System8dent Inc.NHA2026-10-16
088000968514548plant Implant System8dent Inc.NHA2026-10-16
088000968515088plant Implant System8dent Inc.NHA2026-10-16
088000968515918plant Implant System8dent Inc.NHA2026-10-16
088000968516458plant Implant System8dent Inc.NHA2026-10-16
088000968516528plant Implant System8dent Inc.NHA2026-10-16
088000968516698plant Implant System8dent Inc.NHA2026-10-16
088000968581328plant Implant System8dent Inc.NHA2026-10-16
088000968586518plant Implant System8dent Inc.NHA2026-10-16
088000968586688plant Implant System8dent Inc.NHA2026-10-16