FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919641056
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5019505U0
Device description
K0208 BC OBTURATION .06 KIT
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKNPOINT, PAPER, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919641056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919641056008879196410568879196410560887919641056

GMDN Terms#

Term, Definition table
TermDefinition
Root canal obturation kitA collection of sterile dental devices, synthetic materials, and solutions designed to permanently prime, seal, and fill a tooth undergoing a root canal procedure. This device typically includes materials such as a primer (for bonding to the walls of the canal), a sealer (for bonding to the primer), and endodontic points and pellets (for the filling). This bonding process creates a monoblock filling resulting in increased resistance to bacteria penetration and fracture for root canal-treated teeth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082080136
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535030853Brasseler USA5032379U05032379U02026-08-21
08404535030822Brasseler USA5032378U05032378U02026-07-13
00887919912125Brasseler USA5029292U05029292U02023-01-25
00887919752943Brasseler USA5025355U05025355U02026-07-27
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19
00887919711681Brasseler USA5024423U05024423U02026-06-19
00887919683902Brasseler USA5023604U05023604U02026-07-13
08404535030761Brasseler USA5032375U05032375U02026-07-13
08404535030792Brasseler USA5032376U05032376U02026-07-13
08404535018981Brasseler USA5031820U05031820U02026-06-26
08404535019018Brasseler USA5031821U05031821U02026-06-26
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941974305156Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974305170Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974305200Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974308461Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974308577Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974309277Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974316343Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974319764Gutta Percha Points Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
08800069213463Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213470Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213487Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213494Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213500Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213517Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213524Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213531Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213548Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213555Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213562Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213579Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213586Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213593Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213609Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213616Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213142Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213159Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213166Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213173Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069204850XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204867XP-4DSURE DENT CORPORATIONEKN2025-01-07