FDA.reportPublic FDA data

HurriSeal Dentin Desensitizer Snap-N-Go Swab

Primary DI
02723797697113
Brand
HurriSeal Dentin Desensitizer Snap-N-Go Swab
Company
BEUTLICH PHARMACEUTICALS, LLC
Model
Snap-N-Go Swab
Device description
Single swab applicator - Dentin desensitizing liquid formula
Published
2016-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973002000HURRISEAL DENTIN DESENSITIZERCheng & Assoc., Inc.1998-03-23KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01723797697114PackageGS12In Commercial Distribution
01723797697473PackageGS136In Commercial Distribution
01723797697589PackageGS112In Commercial Distribution
02723797697113PackageGS13000In Commercial Distribution
02723797697588PackageGS1156In Commercial Distribution
10723797697471PackageGS136In Commercial Distribution
10723797697587PackageGS112In Commercial Distribution
20723797697119PackageGS12In Commercial Distribution
20723797697584PackageGS1156In Commercial Distribution
00723797697115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01723797697114017237976971141723797697114
01723797697473017237976974731723797697473
01723797697589017237976975891723797697589
02723797697113027237976971132723797697113
02723797697588027237976975882723797697588
1072379769747110723797697471
1072379769758710723797697587
2072379769711920723797697119
2072379769758420723797697584
00723797697115007237976971157237976971150723797697115

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze.
Special Storage Condition, Specify00Refrigerate if not used for long periods of time.
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-238-8542regulatory@beutlich.com

Regulatory Flags#

DUNS number
005209325
Device count
1
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10723797170615InstaNumb17060283-1706-442026-04-15
10723797170721InstaNumb17070283-1707-442026-04-15
10723797170837InstaNumb17080283-1708-442026-04-15
10723797170943InstaNumb17090283-1709-442026-04-15
10723797806446Hurri-Freeze115mL Mist2025-12-15
10723797807443Hurri-Freeze115mL Medium Stream2025-12-15
10723797809447Hurri-Freeze35mL Mist2025-12-15
20723797806443Hurri-Freeze115mL Mist2025-12-15
20723797807440Hurri-Freeze115mL Medium Stream2025-12-15
10723797808440Hurri-Freeze35mL Medium Stream0283-1808-442025-12-15
20723797809444Hurri-Freeze35mL Mist2025-12-15
00723797697115HurriSeal Dentin Desensitizer Snap-N-Go SwabSnap-N-Go Swab2016-10-01
10723797697143HurriSeal Dentin Desensitizer 5mL5mL bottle2020-01-07
10723797697822HurriSeal Dentin Desensitizer 12mL12mL bottle2020-01-07
01723797697145HurriSeal Dentin Desensitizer 5mL5mL bottle2016-10-01
01723797697824HurriSeal Dentin Desensitizer 12mL12mL bottle2016-10-01
00723797010419HurriViewbase unit2019-10-01
00723797110515HurriView IIbase unit2019-10-01
02723797104727HurriViewbase unit2019-10-01
02723797110575HurriView IIbase unit2019-10-01

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