FDA.reportPublic FDA data

HurriSeal Dentin Desensitizer 12mL

Primary DI
01723797697824
Brand
HurriSeal Dentin Desensitizer 12mL
Company
BEUTLICH PHARMACEUTICALS, LLC
Model
12mL bottle
Device description
12mL bottle - dentin desensitizing liquid formula.
Published
2016-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
02723797697823PackageGS172In Commercial Distribution
01723797697824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
02723797697823027237976978232723797697823
01723797697824017237976978241723797697824

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
Lot or batch
true
Expiration date on label
true

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
00723797010419HurriViewbase unit2019-10-01
00723797110515HurriView IIbase unit2019-10-01
02723797104727HurriViewbase unit2019-10-01
02723797110575HurriView IIbase unit2019-10-01
02723797697113HurriSeal Dentin Desensitizer Snap-N-Go SwabSnap-N-Go Swab2016-10-01

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