FDA.reportPublic FDA data

Brasseler USA

Primary DI
08404535038422
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5032514U0
Catalog number
5032514U0
Device description
WVU RESTORATIVE OPER FINISHING
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZPINSTRUMENT, DIAMOND, DENTAL
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08404535038422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08404535038422084045350384228404535038422

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
08404535038446Brasseler USA5032515U05032515U02026-10-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810149983191ROOTTTRATE LLCEJL2026-10-26
E0HM51008203140041n/aHager & Meisinger Gesellschaft mit beschränkter HaftungDZP2026-10-23
E0HM510820C3140021n/aHager & Meisinger Gesellschaft mit beschränkter HaftungDZP2026-10-23
E0HM510820C3140031n/aHager & Meisinger Gesellschaft mit beschränkter HaftungDZP2026-10-23
E0HM510820G3140051n/aHager & Meisinger Gesellschaft mit beschränkter HaftungDZP2026-10-23
E0HM72C1170FG1n/aHager & Meisinger Gesellschaft mit beschränkter HaftungEJL2026-10-23
E0HM72C169FG1n/aHager & Meisinger Gesellschaft mit beschränkter HaftungEJL2026-10-23
08404535025309Brasseler USAPeter Brasseler Holdings, LLCDZP2026-04-29
08404535025309Brasseler USAPeter Brasseler Holdings, LLCEJL2026-04-29
E527049101DA1ECOLINE Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-08-09
E527041456DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041496DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041508DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041514DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041522DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041540DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041541DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041542DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041543DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041544DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041545DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041546DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041550DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041557DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041565DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041566DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041567DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041571DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041573DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E527041576DA1Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01