FDA.reportPublic FDA data

MARK3

Primary DI
D79659701
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
5970
Device description
Endo Pulp Vitality Refrigerant Spray 6oz. Bottle - MARK3®
Published
2021-10-04
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
D79659701PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
096191093
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
00850014374648MARK3863-014C863-014C2025-10-16
00850014374655MARK3837-018XC837-018XC2025-10-16
D79690931MARK3909390932022-03-25
D79690901MARK390902017-04-14
D79690911MARK390912017-04-14
D79690921MARK390922017-04-14
D79641251MARK3412541252022-05-27
D79641261MARK3412641262022-05-27
D79653701MARK3537053702022-05-19
D79690031MARK390032025-03-06
D7969003MARK390032025-03-06
D79690011MARK390012025-02-28
D7969001MARK390012025-02-28
D7966125CS1MARK36125CS2021-04-22
D7966127CS1MARK36127CS2021-04-22
D7966129CS1MARK36129CS2021-04-23
D79661270MARK361272021-04-23
D79661290MARK361292021-04-23

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
00195062030093Vitality ScannerKerr CorporationEAT2021-03-05
00195062030109Vitality ScannerKerr CorporationEAT2021-03-05
00195062030116Vitality ScannerKerr CorporationEAT2021-03-05