FDA.report

Health-Tec Endo Refrigerant Spray

Primary DI
D773330100052
Brand
Health-Tec Endo Refrigerant Spray
Company
Dental Health Products Inc
Model
330-10005
Catalog number
330-10005
Device description
Health-Tec Endo Refrigerant Spray
Published
2017-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EATTester, Pulp

Product Code Classifications

CodeDeviceSpecialtyClass
EATTester, PulpDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D773330100052PackageHIBCC12In Commercial Distribution
D773330100051PrimaryHIBCC0

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
800-626-2163mhull@dhpi.net

Regulatory Flags

DUNS number
623191194
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D7735901000721DHP/Health-Tec Sterilization Tape 590-100072590-1000722023-03-24
D7735901000821DHP/Health-Tec Sterilization Tape590-100082590-1000822023-03-24
D7736001000320DHP/Health-Tec Sterilization Pouches600-100032600-1000322023-03-23
D7736001000420DHP/Health-Tec Sterilization Pouches600-100042600-1000422023-03-23
D7736001000520DHP/Health-Tec Sterilization Pouches600-100052600-1000522023-03-23
D7736001000620DHP/Health-Tec Sterilization Pouches600-100062600-1000622023-03-23
D7736001000720DHP/Health-Tec Sterilization Pouches600-100072600-1000722023-03-23
D7736001000820DHP/Health-Tec Sterilization Pouches600-100082600-1000822023-03-23
D7736001000920DHP/Health-Tec Sterilization Pouches600-100092600-1000922023-03-23
D7736001001020DHP/Health-Tec Sterilization Pouches600-100102600-1001022023-03-23
D7736001001120DHP/Health-Tec Sterilization Pouches600-100112600-1001122023-03-23
D773970100010Health-Tec/DHP Disposable Prophy Angles970-10001970-100012022-11-28
D773970100020Health-Tec/DHP Disposable Prophy Angles970-10002970-100022022-11-28
D7739705220140Health-Tec/DHP Disposable Prophy Angles970-522014970-5220142022-11-28
D773970522140Health-Tec/DHP Disposable Prophy Angles970-522114970-5221142022-11-28
D7739705224140Health-Tec/DHP Disposable Prophy Angles970-522414970-5224142022-11-28
D7739705225140Health-Tec/DHP Disposable Prophy Angles970-522514970-5225142022-11-28
D773930100060Health-Tec/DHP PSP Barrier Envelopes930-10006930-100062022-11-14
D773930HTBWT0Health-Tec/DHP Bite Wing Tabs930-HTBWT930-HTBWT2022-11-14
D773800100020Health-Tec/DHP Matrix Bands800-10002800-100022022-11-10

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