FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919571919
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5013159U0
Device description
UWO ASST INST 1ST YR 2006
Published
2022-12-08
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
ELJTEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELJTeeth, Artificial, Posterior With Metal InsertDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919571919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919571919008879195719198879195719190887919571919

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental burnisher, reusableA hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919581727DENTFLEX FIBER POST5013918L05013918L02026-09-25
00887919581741DENTFLEX FIBER POST5013919L05013919L02026-09-25
00887919581765DENTFLEX FIBER POST5013920L05013920L02026-09-25
08404535030334Brasseler USA5032038U05032038U02026-09-25
08404535030365Brasseler USA5032039U05032039U02026-09-25
08404535030396Brasseler USA5032040U05032040U02026-09-25
08404535030426Brasseler USA5032041U05032041U02026-09-25
08404535030433Brasseler USA5032042U05032042U02026-09-25
08404535030464Brasseler USA5032043U05032043U02026-09-25
08404535030488Brasseler USA5032044U05032044U02026-09-25
08404535030518Brasseler USA5032045U05032045U02026-09-25
08404535030549Brasseler USA5032046U05032046U02026-09-25
08404535030570Brasseler USA5032047U05032047U02026-09-25
08404535030600Brasseler USA5032048U05032048U02026-09-25
08404535030631Brasseler USA5032049U05032049U02026-09-25
08404535030662Brasseler USA5032050U05032050U02026-09-25
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25
00887919749981Brasseler USA5025306U05025306U02023-01-25
00887919752301Brasseler USA5025362U05025362U02023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720604633771Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633788Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633795Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633801Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633818Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633825Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08719425508924Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508948Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508955Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508962Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508979Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508986Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
06975409642004CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15
06975409643001CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15
06975409644008CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15
00887919505587Brasseler USAPeter Brasseler Holdings, LLCELJ2022-12-08
00887919558736Brasseler USAPeter Brasseler Holdings, LLCELJ2022-12-08
08800003006052RAYDENT C&BRay Co., LtdELJ2022-11-03
08800003006069RAYDENT C&BRay Co., LtdELJ2022-11-03
08800003006076RAYDENT C&BRay Co., LtdELJ2022-11-03
08800003006083RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006004RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006011RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006028RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006035RAYDENT C&BRay Co., LtdELJ2022-11-03
18800003006042RAYDENT C&BRay Co., LtdELJ2022-11-03
00850039704178OnX Tough - Hollywood BleachSprintray, Inc.ELJ2022-10-04
00850039704079OnX - BleachSprintray, Inc.ELJ2022-02-28
00850039704086OnX - A1Sprintray, Inc.ELJ2022-02-28
00850039704093OnX - B1Sprintray, Inc.ELJ2022-02-28