FDA.reportPublic FDA data

HurriSeal Dentin Desensitizer 5mL

Primary DI
10723797697143
Brand
HurriSeal Dentin Desensitizer 5mL
Company
BEUTLICH PHARMACEUTICALS, LLC
Model
5mL bottle
Device description
Dentin desensitizing liquid formula. 1 x 5mL bottle in box
Published
2020-01-07
Public version status
Update
Distribution status
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
20723797697140PackageGS172In Commercial Distribution
01723797697145PreviousGS10
10723797697143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2072379769714020723797697140
01723797697145017237976971451723797697145
1072379769714310723797697143

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizing, professionalA substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or 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., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. 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
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
02723797697113HurriSeal Dentin Desensitizer Snap-N-Go SwabSnap-N-Go Swab2016-10-01

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J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
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