FDA.reportPublic FDA data

FROST ENDO SPRAY

Primary DI
D82795475870
Brand
FROST ENDO SPRAY
Company
DARBY DENTAL SUPPLY, LLC
Model
9547587
Catalog number
9547587
Device description
FROST ENDO SPRAY
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EATTester, pulp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EATTester, PulpDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930764000ENDO-ICE-PULP TESTER-THERMALThe Hygenic Corp.1993-05-27EAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D82795475870PrimaryHIBCC0

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
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags#

DUNS number
825137818
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
00889813067994Darby Dental Supply, LLC525879552587952026-02-12
00889813068007Darby Dental Supply, LLC525879652587962026-02-12
00889813068021Darby Dental Supply, LLC525879752587972026-02-12
00889813068038Darby Dental Supply, LLC525879852587982026-02-12
00889813068045Darby Dental Supply, LLC525879952587992026-02-12
00889813068052Darby Dental Supply, LLC525879052587902026-02-12
00889813068069Darby Dental Supply, LLC525879152587912026-02-12
00889813068076Darby Dental Supply, LLC525879252587922026-02-12
00889813068083Darby Dental Supply, LLC525879352587932026-02-12
00889813068090Darby Dental Supply, LLC525879452587942026-02-12
00889813048566Darby Dental Supply, LLC943020394302032022-07-18
00889813048580Darby Dental Supply, LLC943020494302042022-07-18
00889813048610Darby Dental Supply, LLC943020594302052022-07-18
00889813048672Darby Dental Supply, LLC943021094302102022-07-18
00889813048696Darby Dental Supply, LLC943021194302112022-07-18
00889813048719Darby Dental Supply, LLC943021294302122022-07-18
00889813048443Darby Dental Supply, LLC943020294302022022-07-18
00889813048511Darby Dental Supply, LLC943020194302012022-07-18

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