HurriSeal Dentin Desensitizer 5mL

GUDID 10723797697143

Dentin desensitizing liquid formula. 1 x 5mL bottle in box

BEUTLICH PHARMACEUTICALS, LLC

Dental coating, tooth-desensitizing, professional
Primary Device ID10723797697143
NIH Device Record Key4796aae7-46bf-4877-a546-4d365ceb8741
Commercial Distribution StatusIn Commercial Distribution
Brand NameHurriSeal Dentin Desensitizer 5mL
Version Model Number5mL bottle
Company DUNS005209325
Company NameBEUTLICH PHARMACEUTICALS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com
Phone1-800-238-8542
Emailregulatory@beutlich.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate if not used for long periods of time.

Device Identifiers

Device Issuing AgencyDevice ID
GS101723797697145 [Previous]
GS110723797697143 [Primary]
GS120723797697140 [Package]
Package: 72 count case [72 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-11-05
Device Publish Date2020-01-07

On-Brand Devices [HurriSeal Dentin Desensitizer 5mL]

017237976971455mL bottle - Dentin desensitizing liquid formula.
10723797697143Dentin desensitizing liquid formula. 1 x 5mL bottle in box

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