FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919589150
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5014474U0
Device description
17821.21.30 PAST FIL 2 BLUE 4P
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919589150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919589150008879195891508879195891500887919589150

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation material distribution endpiece, reusableA dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919956815LARGE BONE BLADESSAW6944TSAW6944T2026-10-27
00887919956846LARGE BONE BLADESSAW6945TSAW6945T2026-10-27
00887919956877LARGE BONE BLADESSAW6946TSAW6946T2026-10-27
00887919956969LARGE BONE BLADESSAW6949TSAW6949T2026-10-27
00887919956990LARGE BONE BLADESSAW6950TSAW6950T2026-10-27
00887919957027LARGE BONE BLADESSAW6951TSAW6951T2026-10-27
00887919956907LARGE BONE BLADESSAW6947TSAW6947T2026-10-26
00887919956938LARGE BONE BLADESSAW6948TSAW6948T2026-10-26
08404535025309Brasseler USA5032037U05032037U02026-04-29
00887919673880Brasseler USA5022563U05022563U02023-01-25
00887919676218Brasseler USA5022790U05022790U02023-01-25
00887919676232Brasseler USA5022792U05022792U02023-01-25
00887919676249Brasseler USA5022793U05022793U02023-01-25
00887919810926Brasseler USA5026807U05026807U02023-01-25
08404535020779Brasseler USA5031841U05031841U02026-10-20
08404535020809Brasseler USA5031842U05031842U02026-10-20
08404535037654Brasseler USA5032402U05032402U02026-10-20
08404535037685Brasseler USA5032403U05032403U02026-10-20
08404535036985Brasseler USA5032405U05032405U02026-10-01
00887919581703DENTFLEX FIBER POST5013917L05013917L02026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640452460194Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460200Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460217Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460224Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460231Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460248Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460255Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460262Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460279Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460286Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460293Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460309Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460316Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460323Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460330Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460347Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460354Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460361Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460378Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460385Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460392Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460408Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460415Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460422Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460439Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460446Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460453Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460460Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460477Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460484Edge EvolveFKG Dentaire SàrlEKS2026-10-27