FDA.reportPublic FDA data

Metal Triple Edge Button

Primary DI
D829B770000000M0501
Brand
Metal Triple Edge Button
Company
EC Certification Service GmbH
Model
B70-0000-00M
Device description
Metal Triple Edge Button
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EJFBracket, Metal, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D829B770000000M0501PrimaryHIBCC0
D829B770000000M0Unit of UseHIBCC0

Regulatory Flags#

DUNS number
300669699
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
D829B770000000M0051Metal Triple Edge ButtonB70-0000-00M2026-11-05
D829B770000000M0101Metal Triple Edge ButtonB70-0000-00M2026-11-05
D82944S01520300501Premium Line44S-0152-0302026-07-31
D82944S01620300051Premium Line44S-0162-0302026-07-31
D82944S01620300101Premium Line44S-0162-0302026-07-31
D82944S01620300501Premium Line44S-0162-0302026-07-31
D82944S01720300051Premium Line44S-0172-0302026-07-31
D82944S01720300101Premium Line44S-0172-0302026-07-31
D82944S01720300501Premium Line44S-0172-0302026-07-31
D82944S01820300051Premium Line44S-0182-0302026-07-31
D82944S01820300101Premium Line44S-0182-0302026-07-31
D82944S01820300501Premium Line44S-0182-0302026-07-31
D82944S01920300051Premium Line44S-0192-0302026-07-31
D82944S01920300101Premium Line44S-0192-0302026-07-31
D82944S01920300501Premium Line44S-0192-0302026-07-31
D82944S02020300051Premium Line44S-0202-0302026-07-31
D82944S02020300101Premium Line44S-0202-0302026-07-31
D82944S02020300501Premium Line44S-0202-0302026-07-31
D82955112411000051Premium Line551-1241-1002026-07-31
D82955112411000101Premium Line551-1241-1002026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D829B770000000M0051Metal Triple Edge ButtonEC Certification Service GmbHEJF2026-11-05
D829B770000000M0101Metal Triple Edge ButtonEC Certification Service GmbHEJF2026-11-05
00197998062162SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062179SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062414SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062421SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062438SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062445SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062452SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062469SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062742SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062759SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062858SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062889SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998062902SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063145SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063442SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063459SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063466SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063473SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063589SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063596SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063602SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063619SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063626SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063633SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063640SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063657SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063664SolventumSolventum Orthodontics CorporationEJF2026-11-04
00197998063756SolventumSolventum Orthodontics CorporationEJF2026-11-04