COLD AS ICE

Primary DI
00852509006027
Brand
COLD AS ICE
Company
ECOTEC MANUFACTURING, INC.
Model
250
Device description
Endo Freeze Spray
Published
2017-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IFISprays, Synthetic, Smear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFISprays, Synthetic, SmearPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852509006058PackageGS112In Commercial Distribution
00852509006027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852509006058008525090060588525090060580852509006058
00852509006027008525090060278525090060270852509006027

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
2547724661savetime@wonderfill.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
00860177000629ENDODONTIC SPRAY#ENSP2018-02-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860177000681DYNAMIC FREEZEECOTEC MANUFACTURING, INC.IFI2025-07-29
00860009716124SPRAY / PUMPJhk, Inc.IFI2023-07-28
00860009716155SPRAY / PUMPJhk, Inc.IFI2023-07-28
00860177000636Max Pro Medical Freeze SprayECOTEC MANUFACTURING, INC.IFI2018-08-15