FDA.reportPublic FDA data

ENDODONTIC SPRAY

Primary DI
00860177000629
Brand
ENDODONTIC SPRAY
Company
ECOTEC MANUFACTURING, INC.
Model
#ENSP
Device description
ENDODONTIC SPRAY PULP VITALITY REFRIGERANT
Published
2018-02-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
10860177000626PackageGS112In Commercial Distribution
00860177000629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086017700062610860177000626
00860177000629008601770006298601770006290860177000629

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-605-8061sales@3d-dent.com

Regulatory Flags#

DUNS number
121411859
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080491010Marie ReikoAB10012025-10-13
00850080491003Marie ReikoAB20012025-10-13
00850080491065Dental City41-2052026-05-14
00850080491058Darby Dental Supply52548992026-05-07
00850080491034Primo Dental ProductsRE152SP2025-11-26
00850080491027Advance Dental Products8000012025-10-21
00860177000681DYNAMIC FREEZEZPL FR-67452025-07-29
00860177000698Allure OrthoFR-3151622025-07-29
00817744022720Primo FreezeRE100SP2024-10-02
00752080000035SkyChoice Polar-FreezeKY10602024-09-25
00752080000028Hexa FreezeHFE-00012024-09-24
00752080000011RMH3 Dental001-11002024-08-19
00810132807435HOUSE BRAND DENTISTRY HSB-1021252024-03-18
D771412051WINTERGREEN FREEZE SPRAY41-2052023-10-31
00860177000643Endodontic Specialists of Northern Colorado Endo IceMF-3164472019-03-11
10860177000640Endodontic Specialists of Northern Colorado Endo IceMF-3164472019-03-11
00860177000636Max Pro Medical Freeze SprayMPMF-65672018-08-15
00852509006027COLD AS ICE2502017-11-21

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
00887919807193Brasseler USAPeter Brasseler Holdings, LLCEAT2022-12-09
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