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
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
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