FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919807193
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5026551U0
Device description
PULP VITALITY SPRAY 1P
Published
2022-12-09
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
EATTester, pulp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EATTester, PulpDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919807193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919807193008879198071938879198071930887919807193

GMDN Terms#

Term, Definition table
TermDefinition
Cryogenic spray, dentalA liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. After application, this device cannot be reused.

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
00887919912125Brasseler USA5029292U05029292U02023-01-25
00887919752943Brasseler USA5025355U05025355U02026-07-27
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19
00887919711681Brasseler USA5024423U05024423U02026-06-19
00887919683902Brasseler USA5023604U05023604U02026-07-13
08404535030761Brasseler USA5032375U05032375U02026-07-13
08404535030792Brasseler USA5032376U05032376U02026-07-13
08404535030822Brasseler USA5032378U05032378U02026-07-13
08404535018981Brasseler USA5031820U05031820U02026-06-26
08404535019018Brasseler USA5031821U05031821U02026-06-26
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080491065Dental CityECOTEC MANUFACTURING, INC.EAT2026-05-14
00850080491058Darby Dental SupplyECOTEC MANUFACTURING, INC.EAT2026-05-07
00371347019902Advance Dental ProductsThe Atlanta Dental Supply CompanyEAT2026-04-16
00840016202056CanalProCOLTENE/WHALEDENT INCEAT2026-02-10
10840016202053CanalProCOLTENE/WHALEDENT INCEAT2026-02-10
00850080491034Primo Dental ProductsECOTEC MANUFACTURING, INC.EAT2025-11-26
00850080491027Advance Dental ProductsECOTEC MANUFACTURING, INC.EAT2025-10-21
00850080491003Marie ReikoECOTEC MANUFACTURING, INC.EAT2025-10-13
00850080491010Marie ReikoECOTEC MANUFACTURING, INC.EAT2025-10-13
00860177000698Allure OrthoECOTEC MANUFACTURING, INC.EAT2025-07-29
00817744022720Primo FreezeECOTEC MANUFACTURING, INC.EAT2024-10-02
00752080000035SkyChoice Polar-FreezeECOTEC MANUFACTURING, INC.EAT2024-09-25
00752080000028Hexa FreezeECOTEC MANUFACTURING, INC.EAT2024-09-24
00752080000011RMH3 DentalECOTEC MANUFACTURING, INC.EAT2024-08-19
00810132807435HOUSE BRAND DENTISTRY ECOTEC MANUFACTURING, INC.EAT2024-03-18
D771412051WINTERGREEN FREEZE SPRAYECOTEC MANUFACTURING, INC.EAT2023-10-31
00889813059845Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAT2023-05-25
00810000521029Digitest™PARKELL, INC.EAT2022-12-23
00371347008128Advance Dental ProductsThe Atlanta Dental Supply CompanyEAT2022-12-07
10371347008125Advance Dental ProductsThe Atlanta Dental Supply CompanyEAT2022-12-07
D773330100050Health-Tec/DHP Refrigerant SprayDental Health Products IncEAT2022-10-20
06970873260013PULP TESTERDENJOY DENTAL CO.,LTDEAT2022-02-19
00810000520077Gentle Pulse™PARKELL, INC.EAT2021-12-10
00810000520657Digitest™PARKELL, INC.EAT2021-12-10
00810000520961Gentle Pulse™PARKELL, INC.EAT2021-12-10
00810000520978Gentle Pulse™PARKELL, INC.EAT2021-12-10
D79659701MARK3CARGUS INTERNATIONAL, INCEAT2021-10-04
00195062030093Vitality ScannerKerr CorporationEAT2021-03-05
00195062030109Vitality ScannerKerr CorporationEAT2021-03-05
00195062030116Vitality ScannerKerr CorporationEAT2021-03-05