FDA.reportPublic FDA data

Brasseler USA

Primary DI
08404535024937
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5032030U0
Catalog number
5032030U0
Device description
PKT44 PKT 4 LAB #4 HANDLE 1P
Published
2026-03-23
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
EIKCARVER, WAX, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08404535024937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08404535024937084045350249378404535024937

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. 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
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
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25
00887919749981Brasseler USA5025306U05025306U02023-01-25
00887919752301Brasseler USA5025362U05025362U02023-01-25
00887919752332Brasseler USA5025363U05025363U02023-01-25
00887919773689Brasseler USA5026069U05026069U02023-01-25
00887919813170Brasseler USA5026828U05026828U02023-01-25
00887919921608Brasseler USA5029442U05029442U02023-01-25
00887919504511Brasseler USA5008861U05008861U02022-12-01
00887919581611DENTFLEX FIBER POST5013908U05013908U02022-12-01
00887919581628DENTFLEX FIBER POST5013909U05013909U02022-12-01
00887919581635DENTFLEX FIBER POST5013910U05013910U02022-12-01
00887919581642DENTFLEX FIBER POST5013911U05013911U02022-12-01
00887919581659DENTFLEX FIBER POST5013912U05013912U02022-12-01
00887919581666DENTFLEX FIBER POST5013913U05013913U02022-12-01
00887919581673DENTFLEX FIBER POST5013914U05013914U02022-12-01
00887919581680DENTFLEX FIBER POST5013915U05013915U02022-12-01
00887919581697DENTFLEX FIBER POST5013916U05013916U02022-12-01
00887919581710DENTFLEX FIBER POST5013917U05013917U02022-12-01
00887919581734DENTFLEX FIBER POST5013918U05013918U02022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB8080TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8090TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8100TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8110TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8120TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8140TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8150TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8050TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8060TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8070TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8160TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8170TBS BASICSACME ENTERPRISE.EIK2026-05-17
00348783010077Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010084Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010091Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010107Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
00348783010060Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-27
00348783012309Premier CarversPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-01
08404535024906Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024968Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
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00840018661301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
08800075627551OSUNG MNDOSUNG MND Co., Ltd.EIK2025-11-03
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