FDA.reportPublic FDA data

Brasseler USA

Primary DI
08404535005134
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5031558U0
Catalog number
5031558U0
Device description
ADHESIVE SENSOR HOLDER
Published
2025-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EGZHolder, film, x-ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08404535005134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08404535005134084045350051348404535005134

GMDN Terms#

Term, Definition table
TermDefinition
Sensor holder, single-useA device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. 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

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
17310234131044TrollByteDirecta ABEGZ2026-09-21
D090101399140DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399150DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399160DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399170DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399180DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399190DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461070DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461090DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461480DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461490DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461500DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461510DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461520DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
00856145008926Two ClikrayONE Universal Holders WINE + Two G-Rings and RodsCLIKTECH LLCEGZ2026-07-17
00840456221891JMUJMU DENTAL, INCEGZ2026-06-08
00840456221907JMUJMU DENTAL, INCEGZ2026-06-08
00840456221914JMUJMU DENTAL, INCEGZ2026-06-08
00840456221921JMUJMU DENTAL, INCEGZ2026-06-08
00840456221938JMUJMU DENTAL, INCEGZ2026-06-08
00840456221945JMUJMU DENTAL, INCEGZ2026-06-08
00840456222317JMUJMU DENTAL, INCEGZ2026-06-08
00840456222324JMUJMU DENTAL, INCEGZ2026-06-08
00840456222331JMUJMU DENTAL, INCEGZ2026-06-08
00840456222348JMUJMU DENTAL, INCEGZ2026-06-08
00840456222355JMUJMU DENTAL, INCEGZ2026-06-08
00840456222362JMUJMU DENTAL, INCEGZ2026-06-08
00840456221884JMUJMU DENTAL, INCEGZ2026-06-05
10371347019633Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
10304040192112CarinaHENRY SCHEIN, INC.EGZ2025-05-13