FDA.reportPublic FDA data

CM LOC®

Primary DI
07640166511175
Brand
CM LOC®
Company
Cendres+Métaux SA
Model
05001605
Catalog number
05001605
Device description
05001605 CM LOC® Male Part C for casting-on and soldering technique
Published
2019-02-22
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
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
07640166511175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166511175076401665111757640166511175

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

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
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20
088000968621778plant Implant System8dent Inc.NHA2026-10-20
088000968642878plant Implant System8dent Inc.NHA2026-10-20
088000968645778plant Implant System8dent Inc.NHA2026-10-20
088000968782398plant Implant System8dent Inc.NHA2026-10-20
10841307135883Legacy™ DIRECTarch™ 3.0 MUA Replacement ScrewIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135890Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135906Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135913Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 3.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135920Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 4.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135937Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 5.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135944Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135951Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135968Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135975Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135982Legacy™ DIRECTarch™ 3.5 MUA Replacement ScrewIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307135999Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136002Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136019Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 3.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136026Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 4.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136033Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 5.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136040Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 1.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20
10841307136057Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 2.0mmL CollarIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2026-10-20